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cfDNA assay during treatment of acute rejection
The objective of this study is to determine whether cell-free DNA (cf-DNA) measurement can be used as a biomarker for successful treatment of an acute rejection (AR) episode after kidney transplantation.
Arthur Matas, MD
All
18 Years to old
STUDY00005393
STUDY00005393
Inclusion Criteria:
Adult kidney transplant recipients undergoing transplant biopsy between 1 and 12 months post-transplant because of graft dysfunction.
Exclusion Criteria:
<1 months post-transplant
>12 months post-transplant Genetic: cf-DNA Collection
Kidney Transplant Failure and Rejection, Kidney Transplant, Complications, Kidney Transplant Rejection, Transplant, Complication, Rejection, Transplant Dysfunction
Assessment of bimodal stimulation device compliance and satisfaction in individuals with tinnitus
Tinnitus or 'ringing in the ears' is a neurological condition affecting brain signals. Around 10-15% of the global population is affected by tinnitus. Many of those living with tinnitus report feeling distressed bytheir symptoms and a negative effect on their quality of life. Unfortunately, there are fewreliable treatment options for people with tinnitus. This study expands on research that found a noninvasive therapy combining audio and tongue stimulation to reduce the severity of tinnitus symptoms. The development of a treatment for tinnitus would meet an unmet need and advance care for military personnel, Veterans and the public. This study involves the use of an investigational device, which means that it has not been approved yet by the FDA for reducing tinnitus symptoms. The device we will use in this study is approved for use in Europe. In Europe, it is fitted in a clinical setting, and patient’s pure-tone audiometric thresholds (hearing ability) need to be obtained by a hearing specialist. Those audiometric hearing thresholds are then used to set up the sound stimuli to a comfortable audible level above the patient's hearing threshold. Adjustments to the device are also completed in a clinical setting. For this pilot study, the researchers want to assess if they can streamline the process of using the device by allowing patients to adjust their own sound stimuli levels within a safe range. This study will also have virtual follow-up assessments, reducing the burden for in person visits that are currently used for the approved device use. We want to know if patients will follow instructions reliably in regards to the use of the device and adjustments, and also if they remain satisfied when the in person clinical burdens are removed.
Meredith Adams
Male or Female
18 Years and over
STUDY00015524
STUDY00015524
Inclusion Criteria:
• 18 years and over at time of consent
• Ability to read and understand English
• Willing and able to provide and understand informed consent
• Willing to commit to the full duration of the investigation
• Subjective tinnitus
• Tinnitus duration of greater than or equal to 3 months and less than or equal to 20 years at time of consent
• Baseline THI score from 38 to 76
• Hearing loss condition
• Low hearing loss group (minimum n=4)
• High hearing loss group (minimum n=4)
• Access to reliable internet connection and device to complete virtual video visits and electronic surveys
Exclusion Criteria:
• Subjective tinnitus, where pulsatility is the dominant feature
• Objective tinnitus
• Middle ear pathology in either ear including documented/known conductive hearing loss >= 20 dB at three adjacent frequencies or if a diagnosis of a tympanic membrane perforation or other middle ear pathology has been rendered, if there is an indwelling pressure equalization tube by patient report, or if middle ear surgery has been performed.
• Began wearing hearing aids within the past 3 months
• Hearing loss greater than 90 dB HL in the set 250, 500, 1k Hz
• Health care provider has rendered a diagnosis of Meniere?s disease or other disorder with fluctuating hearing loss
• A diagnosis of hyperacusis, misophonia or hypersensitivity to loud noises has been rendered
• History of auditory hallucinations
• Tumor on the hearing or balance nervous systems
• Hospitalization, or visit to a physician, for a head or neck injury, including whiplash, in the previous 12 months
• Initiated new prescription medications or medical treatments in the previous 3 months that may impact the outcomes of the investigation, based on class of medication: antidepressants, anticonvulsants, neuroleptics and opioid analgesics. See Appendix 2 for list of medical treatments.
• Ceased prescription medications or medical treatments in the previous 3 months that may impact the outcomes of the investigation, based on class of medication: antidepressants, anticonvulsants, neuroleptics and opioid analgesics. See Appendix 2 for list of medical treatments.
• Changed dosage of prescription medications in the previous 3 months that may impact the outcomes of the investigation, based on class of medication: antidepressants, anticonvulsants, neuroleptics and opioid analgesics. See Appendix 2 for list of medical treatments.
• Any use of benzodiazepines or sedative hypnotics (either regularly or on demand)
• Neurological condition that may lead to seizures or loss of consciousness (e.g., epilepsy)
• Participant with a pacemaker or other electro-active implanted device
• Participant previously diagnosed with psychosis or schizophrenia
• Participants diagnosed with Burning Mouth Syndrome
• A diagnosis of bothersome temporomandibular joint disorder (TMJ) has been rendered
• Previous involvement in a clinical investigation for tinnitus treatment or had an implantable or surgical intervention for tinnitus
• Inability to physically or comprehensively use the device
• Oral piercings that cannot or will not be removed
• Current or previous involvement in medico-legal cases
• Pregnancy per patient report
• Prisoner
• PI does not deem the candidate to be suitable for the investigation for other reasons not listed above. Rationale must be provided.
Ear, Nose & Throat
audiology, bimodal stimulation, ear, hearing, lenire, tinnitus, neuromod
EPI-MINN: Targeting Cognition and Motivation in Coordinated Specialty Care for Early Psychosis
The purpose of this study is to perform a practice-based research project designed to assess whether cognition and motivated behavior in early psychosis can be addressed as key treatment goals within real-world settings by using a 12-week mobile intervention program. The aim of this study is to investigate a well-defined 12-week mobile intervention program specifically designed to target cognitive functioning and motivated behavior for individuals with early psychosis. We will test for differences in the clinical trajectories over 18 months in those who receive the intervention vs. those who do not.
Sophia Vinogradov
All
15 Years to 40 Years old
N/A
STUDY00011512
STUDY00011512
Inclusion Criteria:
Enrolled in EPI-MINN: Measurement Based Care protocol, STUDY00009334
Good general health (i.e. not acutely ill or experiencing a severe/chronic illness that would impede their ability to complete study activities. This determination shall be, if necessary, made at the discretion of the PIs)
Estimated IQ at or above 70, as estimated by the Penn CNP Matrix Reasoning Test
Achieved clinical stability, defined as outpatient status for at least one month prior to study participation and clinically stable doses of psychiatric medication (by PI discretion) for at least one month prior to study participation (including no medication)
Has access to a smartphone or other mobile device to use the PRIME app
Exclusion Criteria:
Under legal commitment to treatment or is under medical guardianship, and there is no provision in the guardianship order or a court order to allow the guardian to consent to participation in research
Participated in significant cognitive training programs within the last three years
Diagnosed with a neurological disorder (Autism Spectrum Disorder is allowed)
Clinically significant substance abuse that is impeding the participant's abulity to participate fully during recruitment, enrollment, assessment, or training, (is unable to remain sober for assessments and training)
Risk of suicidal behavior, as indicated by the clinicall obtained C-SSRS or clinician judgement. Risk of suicidal behavior is defined as:
Active suicidal ideation at screening or baseline, or
Previous intent to act on suicidal ideation with a specific plan, preparatory acts, or an actual suicide attempt within the last 3 months Device: Cognitive and Social Cognitive Training, Other: Early Psychosis Coordinated Specialty Care, Behavioral: Personalized Real-Time Intervention for Motivational Enhancement (PRIME) App
Psychosis
Cognitive Training, Motivation Enhancement, First Episode Psychosis, Schizophrenia Spectrum Disorders
Targeting Family Meal Quality and Quantity to Reduce Childhood Obesity Using Ecological Momentary Intervention (EMI) and Video Feedback
The proposed study is an individual three-arm randomized controlled tiled aimed at utilizing state-of-the-art intervention methods to examine whether increasing the quality and the quantity of family meals reduces childhood obesity.
Jerica Berge
Male or Female
up to 18 Years old
NA
STUDY00000706
STUDY00000706
Inclusion Criteria:
Child 5-10 years old; Have a sibling who lives in the home with the child; Live in the Metro area; Speaks English or Spanish Behavioral: Ecological Momentary Intervention, Behavioral: Feedback on Video-recorded Family Meals, Behavioral: In-home Visits and Food Preparation Activities, Behavioral: Maintenance
Children's Health
family, family meals, nutrition, primary care
CureGN: Cure Glomerulonephropathy Network Version 2.0
The purpose of CureGN2 is to gather a group of people with glomerular disease to create a source of information and blood and urine samples, so that researchers can easily and effectively study glomerular disease.
Michelle Rheault
Male or Female
Not specified
STUDY00009629
STUDY00009629
Inclusion Criteria:
• Diagnosis of Glomerular Disease including MCD (minimal change disease), FSGS (focal segmental glomerulosclerosis), MN (membranous nephropathy), or IgAN (immunoglobulin A nephropathy) on first diagnostic kidney biopsy
• First diagnostic kidney biopsy within 5 years of study enrollment
• Access to first kidney biopsy report and/or slides
• All ages
Exclusion Criteria:
• End Stage Kidney Disease, defined as chronic dialysis or kidney transplant
• Institutionalized patient
• Solid organ or bone marrow transplant recipient at time of first kidney biopsy
• Diagnosis of any of the following at the time of first diagnostic kidney biopsy: o Diabetes mellitus (except gestational or diet controlled) o Histopathologic findings of diabetic glomerulosclerosis o Systemic lupus erythematosus o HIV infection o Active malignancy, except for non-melanoma skin cancer o Active Hepatitis B or C infection, defined as positive viral load
Kidney, Prostate & Urinary, Rare Diseases
Kidney, Glomerular Disease
MT2019-41: A Phase 2 Clinical Trial to Evaluate the Efficacy of the Infusion of Autologous CD34+ Cells Transduced with a Lentiviral Vector Carrying the FANCA Gene in Pediatric Subjects with Fanconi Anemia Subtype A
The objective of this study is to assess the therapeutic efficacy of a hematopoietic gene therapy consisting of autologous CD34+ enriched cells transduced with a LV carrying the FANCA gene in subjects with FA-A.
Margaret MacMillan, MD
All
1 Year to old
Phase 2
STUDY00008719
STUDY00008719
Inclusion Criteria:
Fanconi anemia as diagnosed by chromosomal fragility assay of cultured lymphocytes in the presence of DEB or a similar DNA-crosslinking agent
Patients of the complementation group FA-A
Minimum age: 1 year and a minimum weight of 8 kg
At least 30 CD34+ cells/μL are determined in one bone marrow (BM) aspiration within 3 months prior to CD34+ cell collection OR (see subsequent criterion)
If the number of CD34+ cells/ μL in BM is in the range of 10-29, peripheral blood (PB) parameters should meet two of the three following criteria:
Hemoglobin: ≥11g/dL
Neutrophils: ≥900 cells/μL
Platelets: ≥60,000 cells/μL
Provide informed consent in accordance with current legislation
Women of childbearing age must have a negative urine pregnancy test at the baseline visit, and accept the use of an effective contraception method during participation in the trial
Exclusion Criteria:
Subjects with an available and medically eligible HLA-identical sibling donor.
Evidence of myelodysplastic syndrome or leukemia, or cytogenetic abnormalities other than those reported as variant(s) of normal in BM aspirate analysis. This assessment should be made by valid studies conducted within the 3 months before the subject commences the stem cell mobilization/collection procedures of the clinical trial.
Subjects with somatic mosaicism associated with stable or improved counts in all PB cell lineages. (If T-lymphocyte chromosomal fragility analysis indicates potential mosaicism, a medically significant decrease (≥1 NCI CTCAE grade) in at least one blood lineage over time must be documented to enable eligibility, as should <5% resistance of bone marrow colony forming cells (CFCs) to 10nM MMC; whenever possible potential mosaicism should also be evaluated by gene sequencing of MMC-resistant CFCs).
Lansky performance status ≤60%.
Any concomitant disease or condition that, in the opinion of the Principal Investigator, renders the subject unfit to participate in the study.
Pre-existing sensory or motor impairment ≥grade 2 according to the criteria of the NCI.
Pregnant or breastfeeding women.
Hepatic dysfunction as defined by either:
Bilirubin >3.0 × the upper limit of normal (ULN) or
Alanine aminotransferase (ALT) > 5.0 × ULN or
Aspartate aminotransferase (AST) > 5.0 × ULN
For subjects with bilirubin, ALT or AST above ULN, a workup to identify the etiology of liver abnormality should be conducted prior to confirmation of eligibility as stipulated in exclusion criterion 5, including evaluation of viral hepatitis, iron overload, drug injury or other causes.
Renal dysfunction requiring either hemodialysis or peritoneal dialysis.
Pulmonary dysfunction as defined by either:
Need for supplemental oxygen during the prior 2 weeks in absence of acute infection or
Oxygen saturation by pulse oximetry <90%.
Evidence of active metastatic or locoregionally advanced malignancy for which survival is anticipated to be less than 3 years.
Subject is receiving androgens (i.e. danazol, oxymetholone).
Subject is receiving other investigational therapy for treatment/prevention of FA-associated bone marrow failure. Biological: RP-L102
Fanconi Anemia Complementation Group A
anemia, bone marrow failure, gene therapy
COG APEC1621A - NCI-COG PEDIATRIC MATCH (MOLECULAR ANALYSIS FOR THERAPY CHOICE)- PHASE 2 SUBPROTOCOL OF LOXO-101 (LAROTRECTINIB) IN PATIENTS WITH TUMORS HARBORING ACTIONABLE NTRK FUSIONS
The NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) study, referred to as Pediatric MATCH, will match targeted agents with specific molecular changes identified using genomic sequencing technologies in refractory/recurrent tumors from children and adolescents with cancer. The NCI-COG Pediatric MATCH study (APEC1621) is considered one study under one IND consisting of a Master Version Control protocol, screening protocol component and multiple subprotocol components, with each component being contained in its own separate document. Each “component” consists of the protocol document and its associated informed consent document. The Master Version Control Protocol is the overarching administrative protocol that will keep an up-to-date record of the current version of the screening protocol component and each subprotocol component of Pediatric MATCH. Since each subprotocol component operates independently from the other subprotocol components contained in Pediatric MATCH, each has its own version date. Likewise, the screening protocol component has its own version date since changes in any of the subprotocols may not require changes in the screening protocol.
Emily Greengard
All
12 Months to 21 Years old
Phase 2
STUDY00001752
STUDY00001752
Inclusion Criteria:
• APEC1621SC: Patient must have enrolled onto APEC1621SC and must have been given a treatment assignment to Molecular Analysis for Therapy Choice (MATCH) to APEC1621A based on the presence of an actionable mutation as defined in APEC1621SC
• Patients must be >= than 12 months and =< 21 years of age at the time of study enrollment
• Patients must have radiographically measurable disease at the time of study enrollment; patients with neuroblastoma who do not have measurable disease but have MIBG+ evaluable disease are eligible; measurable disease in patients with CNS involvement is defined as any lesion that is at minimum 10 mm in one dimension on standard MRI or CT; Note: The following do not qualify as measurable disease:
• Malignant fluid collections (e.g., ascites, pleural effusions)
• Bone marrow infiltration except that detected by MIBG scan for neuroblastoma
• Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography [PET] scans) except as noted for neuroblastoma
• Elevated tumor markers in plasma or cerebrospinal fluid (CSF)
• Previously radiated lesions that have not demonstrated clear progression post radiation
• Leptomeningeal lesions that do not meet the measurement requirements for Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
• Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age; Note: neurologic deficits in patients with CNS tumors must have been relatively stable for at least 7 days prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
• Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required time frame, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately
• Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive; for agents not listed, the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment
• >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)
• Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil [ANC] counts): >= 7 days after the last dose of agent; for agents not listed, the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment
• Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1
• Corticosteroids: if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
• Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; for growth factors that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator
• Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)
• Stem cell Infusions (with or without total body irradiation [TBI]):
• Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor leukocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD)
• Autologous stem cell infusion including boost infusion: >= 42 days
• Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, NK cells, dendritic cells, etc.)
• Radiation therapy (XRT)/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial brain metastases (BM) radiation; Note: radiation may not be delivered to "measurable disease" tumor site(s) being used to follow response to subprotocol treatment
• Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131I-MIBG): >= 42 days after systemically administered radiopharmaceutical therapy
• Patients must not have received prior exposure to other NTRK inhibitors including but not limited to LOXO-101 (larotrectinib), entrectinib (RXDX-101), DS6051, PLX7486
• For patients with solid tumors without known bone marrow involvement:
• Peripheral absolute neutrophil count (ANC) >= 1000/mm^3 (within 7 days prior to enrollment)
• Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment) (within 7 days prior to enrollment)
• Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions); these patients will not be evaluable for hematologic toxicity
• Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2 (within 7 days prior to enrollment) or
• A serum creatinine based on age/gender as follows (within 7 days prior to enrollment):
• Age: 1 to < 2 years; maximum serum creatinine (mg/dL); male: 0.6 female: 0.6
• Age: 2 to < 6 years; maximum serum creatinine (mg/dL); male: 0.8 female: 0.8
• Age: 6 to < 10 years; maximum serum creatinine (mg/dL); male: 1 female: 1
• Age: 10 to < 13 years; maximum serum creatinine (mg/dL); male: 1.2 female: 1.2
• Age: 13 to < 16 years; maximum serum creatinine (mg/dL); male: 1.5 female: 1.4
• Age: >= 16 years; maximum serum creatinine (mg/dL); male: 1.7 female: 1.4
• Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment)
• Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L (within 7 days prior to enrollment); (for the purpose of this study, the ULN for SGPT is 45 U/L)
• Serum albumin >= 2 g/dL (within 7 days prior to enrollment)
• Patients with seizure disorder may be enrolled if on anti-convulsants and well controlled
• Nervous system disorders (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 5.0) resulting from prior therapy must be =< grade 2, with the exception of decreased tendon reflect (DTR); any grade of DTR is eligible
• All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
Exclusion Criteria:
• Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method for the duration of study treatment
• Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
• Patients who are currently receiving another investigational drug are not eligible
• Patients who are currently receiving other anti-cancer agents are not eligible
• Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease (GVHD) post bone marrow transplant are not eligible for this trial
• Patients who are currently receiving drugs that are strong inducers or inhibitors of CYP3A4 are not eligible; strong inducers or inhibitors of CYP3A4 should be avoided from 14 days prior to enrollment to the end of the study; Note: CYP3A4 inducing anti-epileptic drugs and dexamethasone for CNS tumors or metastases, on a stable dose, are allowed
• Patients who have received prior therapy with a specific inhibitor of TRK (including but not limited to entrectinib [RXDX-101], DS-6051b, and PLX7486) are not eligible
• Patients who have an uncontrolled infection are not eligible
• Patients who have received a prior solid organ transplantation are not eligible
• Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible
Procedure: Biospecimen Collection, Procedure: Bone Marrow Aspiration and Biopsy, Procedure: Bone Scan, Procedure: Computed Tomography, Drug: Larotrectinib Sulfate, Procedure: Magnetic Resonance Imaging, Procedure: Radionuclide Imaging, Procedure: X-Ray Imaging
Advanced Malignant Solid Neoplasm, Recurrent Ependymoma, Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Recurrent Glioma, Recurrent Hepatoblastoma, Recurrent Kidney Wilms Tumor, Recurrent Langerhans Cell Histiocytosis, Recurrent Malignant Germ Cell Tumor, Recurrent Malignant Glioma, Recurrent Malignant Solid Neoplasm, Recurrent Medulloblastoma, Recurrent Neuroblastoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Osteosarcoma, Recurrent Rhabdoid Tumor, Recurrent Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Refractory Ependymoma, Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Refractory Glioma, Refractory Hepatoblastoma, Refractory Langerhans Cell Histiocytosis, Refractory Malignant Germ Cell Tumor, Refractory Malignant Glioma, Refractory Malignant Solid Neoplasm, Refractory Medulloblastoma, Refractory Neuroblastoma, Refractory Non-Hodgkin Lymphoma, Refractory Osteosarcoma, Refractory Primary Central Nervous System Neoplasm, Refractory Rhabdoid Tumor, Refractory Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma
COG APEC1621D - NCI-COG PEDIATRIC MATCH (MOLECULAR ANALYSIS FOR THERAPY CHOICE)- PHASE 2 SUBPROTOCOL OF LY3023414 IN PATIENTS WITH SOLID TUMORS
The NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) study, referred to as Pediatric MATCH, will match targeted agents with specific molecular changes identified using genomic sequencing technologies in refractory/recurrent tumors from children and adolescents with cancer. The NCI-COG Pediatric MATCH study (APEC1621) is considered one study under one IND consisting of a Master Version Control protocol, screening protocol component and multiple subprotocol components, with each component being contained in its own separate document. Each “component” consists of the protocol document and its associated informed consent document. The Master Version Control Protocol is the overarching administrative protocol that will keep an up-to-date record of the current version of the screening protocol component and each subprotocol component of Pediatric MATCH. Since each subprotocol component operates independently from the other subprotocol components contained in Pediatric MATCH, each has its own version date. Likewise, the screening protocol component has its own version date since changes in any of the subprotocols may not require changes in the screening protocol.
Emily Greengard
All
12 Months to 21 Years old
Phase 2
STUDY00001752
STUDY00001752
Inclusion Criteria:
• Patient must have enrolled onto APEC1621SC and must have been given a treatment assignment to Molecular Analysis for Therapy Choice (MATCH) to APEC1621D based on the presence of an actionable mutation as defined in APEC1621SC; note that treatment assignment may be to primary cohort A for patients with TSC1 or TSC2 loss of function mutations or primary cohort B for patients with other PI3K/MTOR pathway mutations
• Patients accruing to dose level 1 must have a body surface area >= 0.52 m^2 at the time of study enrollment; patients accruing to dose level 2 must have a body surface area >= 0.37 m^2 at the time of study enrollment; patients accruing to dose level -1 must have a body surface area >= 0.75 m^2 at the time of study enrollment
• Patients must have radiographically measurable disease at the time of study enrollment; patients with neuroblastoma who do not have measurable disease but have metaiodobenzylguanidine (MIBG) positive (+) evaluable disease are eligible; measurable disease in patients with CNS involvement is defined as any lesion that is at minimum 10 mm in one dimension on standard magnetic resonance imaging (MRI) or computed tomography (CT)
• Note: The following do not qualify as measurable disease:
• Malignant fluid collections (e.g., ascites, pleural effusions)
• Bone marrow infiltration except that detected by MIBG scan for neuroblastoma
• Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography [PET] scans) except as noted for neuroblastoma
• Elevated tumor markers in plasma or cerebrospinal fluid (CSF)
• Previously radiated lesions that have not demonstrated clear progression post radiation
• Leptomeningeal lesions that do not meet the measurement requirements for Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
• Bone lesions without an associated soft tissue mass >= 10 mm in greatest diameter; bone lesions with an associated soft tissue mass >= 10 mm in greatest diameter imaged by CT or MRI are considered measurable
• Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age; Note: neurologic deficits in patients with CNS tumors must have been stable for at least 7 days prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
• Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately
• Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive; >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)
• Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days after the last dose of agent
• Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1
• Corticosteroids: if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
• Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; for growth factors that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator
• Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)
• Stem cell Infusions (with or without total body irradiation [TBI]):
• Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD)
• Autologous stem cell infusion including boost infusion: >= 42 days
• Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)
• Radiation therapy (XRT)/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation
• Note: radiation may not be delivered to "measurable disease" tumor site(s) being used to follow response to subprotocol treatment
• Radiopharmaceutical therapy (e.g., radiolabeled antibody, iobenguane I-131 [131I-MIBG]): >= 42 days after systemically administered radiopharmaceutical therapy
• Patients must not have received prior exposure to LY3023414
• Patients must not have received prior exposure to an agent specifically directed at the PI3K/MTOR pathway (a PI3K inhibitor, an AKT inhibitor, an MTOR inhibitor, including rapalogs, or a combined PI3K/MTOR inhibitor)
• For patients with solid tumors without known bone marrow involvement:
• Peripheral absolute neutrophil count (ANC) >= 1000/mm^3
• Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
• Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions); these patients will not be evaluable for hematologic toxicity
• Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2 or a serum creatinine based on age/gender as follows:
• Age: 1 to < 2 years; maximum serum creatinine (mg/dL): male 0.6; female 0.6
• Age: 2 to < 6 years; maximum serum creatinine (mg/dL): male 0.8; female 0.8
• Age: 6 to < 10 years; maximum serum creatinine (mg/dL): male 1; female 1
• Age: 10 to < 13 years; maximum serum creatinine (mg/dL): male 1.2; female 1.2
• Age: 13 to < 16 years; maximum serum creatinine (mg/dL): male 1.5; female 1.4
• Age: >= 16 years; maximum serum creatinine (mg/dL): male 1.7; female 1.4
• Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age
• Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L; (for the purpose of this study, the ULN for SGPT is 45 U/L)
• Serum albumin >= 2 g/dL
• Patients must have a normal blood sugar level for age; if an initial random draw (i.e. non-fasting) blood glucose value is out of range, it is acceptable to repeat this test as a fasting draw
• Patients must have a serum triglyceride level =< 300 mg/dL and serum cholesterol level =< 300 mg/dL; if an initial random draw (i.e. non-fasting) is out of range, it is acceptable to repeat this test as a fasting draw
• Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled
• Nervous system disorders (by Common Terminology Criteria for Adverse Events version
• 0 [CTCAE V 5.0]) resulting from prior therapy must be =< grade 2, with the exception of decreased tendon reflex (DTR); any grade of DTR is eligible
• Corrected QT (QTc) interval =< 480 milliseconds
• Patients must be able to swallow intact tablets
• All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines
Exclusion Criteria:
• Pregnant or breast-feeding women will not be entered on this study; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while receiving study treatment and for 3 months after the last dose of LY3023414
• Concomitant medications
• Corticosteroids: patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
• Investigational drugs: patients who are currently receiving another investigational drug are not eligible
• Anti-cancer agents: patients who are currently receiving other anti-cancer agents are not eligible
• Anti-GVHD agents post-transplant: patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial
• Patients who have an uncontrolled infection are not eligible
• Patients who have insulin dependent diabetes are not eligible
• Patients who have received a prior solid organ transplantation are not eligible
• Patients with subependymal giant cell astrocytomas (SEGAs) are not eligible
• Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible
Procedure: Biospecimen Collection, Procedure: Computed Tomography, Procedure: FDG-Positron Emission Tomography, Procedure: Magnetic Resonance Imaging, Drug: Samotolisib, Procedure: X-Ray Imaging
Advanced Malignant Solid Neoplasm, Ann Arbor Stage III Non-Hodgkin Lymphoma, Ann Arbor Stage IV Non-Hodgkin Lymphoma, Malignant Glioma, Recurrent Ependymoma, Recurrent Ewing Sarcoma, Recurrent Glioma, Recurrent Hepatoblastoma, Recurrent Langerhans Cell Histiocytosis, Recurrent Malignant Germ Cell Tumor, Recurrent Malignant Solid Neoplasm, Recurrent Medulloblastoma, Recurrent Neuroblastoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Osteosarcoma, Recurrent Peripheral Primitive Neuroectodermal Tumor, Recurrent Primary Central Nervous System Neoplasm, Recurrent Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Refractory Langerhans Cell Histiocytosis, Refractory Malignant Germ Cell Tumor, Refractory Malignant Solid Neoplasm, Refractory Neuroblastoma, Refractory Non-Hodgkin Lymphoma, Refractory Primary Central Nervous System Neoplasm, Rhabdoid Tumor, Stage III Osteosarcoma AJCC v7, Stage III Soft Tissue Sarcoma AJCC v7, Stage IV Osteosarcoma AJCC v7, Stage IV Soft Tissue Sarcoma AJCC v7, Stage IVA Osteosarcoma AJCC v7, Stage IVB Osteosarcoma AJCC v7, Wilms Tumor
COG APEC1621M - NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 subprotocol of Tipifarnib in patients with tumors harboring HRAS genomic alterations
The NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) study, referred to as Pediatric MATCH, will match targeted agents with specific molecular changes identified using genomic sequencing technologies in refractory/recurrent tumors from children and adolescents with cancer. The NCI-COG Pediatric MATCH study (APEC1621) is considered one study under one IND consisting of a Master Version Control protocol, screening protocol component and multiple subprotocol components, with each component being contained in its own separate document. Each “component” consists of the protocol document and its associated informed consent document. The Master Version Control Protocol is the overarching administrative protocol that will keep an up-to-date record of the current version of the screening protocol component and each subprotocol component of Pediatric MATCH. Since each subprotocol component operates independently from the other subprotocol components contained in Pediatric MATCH, each has its own version date. Likewise, the screening protocol component has its own version date since changes in any of the subprotocols may not require changes in the screening protocol.
Emily Greengard
All
12 Months to 21 Years old
Phase 2
STUDY00001752
STUDY00001752
Inclusion Criteria:
• Patient must have enrolled onto APEC1621SC and must have been given a treatment assignment to MATCH to APEC1621M based on the presence of an actionable mutation as defined in APEC1621SC
• Patients must be >=12 months and =< 21 years of age at the time of study enrollment
• Patients must have a body surface area >= 0.29 m^2 at enrollment
• Patients must have radiographically measurable disease at the time of study enrollment. Patients with neuroblastoma who do not have measurable disease but have metaiodobenzylguanidine (MIBG) positive (+) evaluable disease are eligible. Measurable disease in patients with CNS involvement is defined as any lesion that is at minimum 10 mm in one dimension on standard magnetic resonance imaging (MRI) or computed tomography (CT)
• Note: The following do not qualify as measurable disease:
• Malignant fluid collections (e.g., ascites, pleural effusions)
• Bone marrow infiltration except that detected by MIBG scan for neuroblastoma
• Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography [PET] scans) except as noted for neuroblastoma
• Elevated tumor markers in plasma or cerebral spinal fluid (CSF)
• Previously radiated lesions that have not demonstrated clear progression post radiation
• Leptomeningeal lesions that do not meet the measurement requirements for Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
• Karnofsky >= 50 for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age. Note: Neurologic deficits in patients with CNS tumors must have been relatively stable for at least 7 days prior to study enrollment. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
• Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment. If after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately
• Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive.
• >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)
• Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days after the last dose of agent.
• Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1
• Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
• Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor. For growth factors that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the study chair and the study-assigned research coordinator
• Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)
• Stem cell infusions (with or without total body irradiation [TBI]):
• Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD)
• Autologous stem cell infusion including boost infusion: >= 42 days
• Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)
• Radiation therapy (XRT)/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation
• Note: Radiation may not be delivered to "measurable disease" tumor site(s) being used to follow response to subprotocol treatment
• Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131I-MIBG): >= 42 days after systemically administered radio-pharmaceutical therapy
• Patients must not have received prior exposure to tipifarnib
• For patients with solid tumors without known bone marrow involvement (within 7 days prior to enrollment):
• Peripheral absolute neutrophil count (ANC) >= 1000/mm^3
• For patients with solid tumors without known bone marrow involvement (within 7 days prior to enrollment):
• Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
• Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions). These patients will not be evaluable for hematologic toxicity
• Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2 (within 7 days prior to enrollment) or
• A serum creatinine based on age/gender as follows (within 7 days prior to enrollment):
• Age: Maximum serum creatinine (mg/dL)
• 1 to < 2 years: male (0.6), female (0.6)
• 2 to < 6 years: male (0.8), female (0.8)
• 6 to < 10 years: male (1), female (1)
• 10 to < 13 years: male (1.2), female (1.2)
• 13 to < 16 years: male (1.5), female (1.4)
• >= 16 years: male (1.7), female (1.4)
• Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment)
• Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L. (For the purpose of this study, the ULN for SGPT is 45 U/L.) (within 7 days prior to enrollment)
• Serum albumin >= 2 g/dL (within 7 days prior to enrollment)
• Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled
• Nervous system disorders (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 5.0) resulting from prior therapy must be =< grade 2
• Patients must be able to swallow intact tablets or crushed tablets mixed in water, orange juice, apple juice, tomato juice, ginger ale, applesauce, yogurt, protein shake, or a dietary supplement drink (such as Ensure). Percutaneous endoscopic gastrostomy (PEG)-tube or nasogastric tube administration is permitted
• All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines
Exclusion Criteria:
• Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use two effective contraceptive methods for the duration of study treatment. Both female subjects and male subjects with female partners of child-bearing potential must agree to use a highly effective method of contraception for 2 weeks prior to protocol therapy, during, and at least 4 weeks after last dose of tipifarnib. In addition, since tipifarnib could induce toxicity of male reproductive organs and cause impairment of fertility, sperm cryopreservation should be recommended for male subjects wishing to preserve their fertility following tipifarnib treatment
• Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible. If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
• Patients who are currently receiving another investigational drug are not eligible
• Patients who are currently receiving other anti-cancer agents are not eligible
• Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial
• Patients who are currently receiving drugs that are strong inducers or inhibitors of CYP3A4/5 or UGT are not eligible. Strong inducers or inhibitors of CYP3A4/5 or UGT should be avoided from 14 days prior to the 1st dose of tipifarnib to the end of the study. In addition, patients receiving agents that are sensitive or narrow therapeutic range substrates of CYP3A4/5 are not eligible. Note: CYP3A4/5 inducing anti-epileptic drugs and dexamethasone for CNS tumors or metastases, on a stable dose, are allowed
• Patients with known hypersensitivity to tipifarnib or any components of the tablet are not eligible
• Patients with hypersensitivity to imidazoles, such as clotrimazole, ketoconazole, miconazole and others in this drug class are not eligible
• Patients who have an uncontrolled infection are not eligible
• Patients who have received a prior solid organ transplantation are not eligible
• Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible
Procedure: Biospecimen Collection, Procedure: Bone Marrow Aspiration and Biopsy, Procedure: Computed Tomography, Procedure: Magnetic Resonance Imaging, Procedure: Positron Emission Tomography, Procedure: Radionuclide Imaging, Drug: Tipifarnib
Malignant Solid Neoplasm, Recurrent Adrenal Gland Pheochromocytoma, Recurrent Ectomesenchymoma, Recurrent Ependymoma, Recurrent Ewing Sarcoma, Recurrent Hepatoblastoma, Recurrent Kidney Wilms Tumor, Recurrent Langerhans Cell Histiocytosis, Recurrent Malignant Germ Cell Tumor, Recurrent Malignant Glioma, Recurrent Medulloblastoma, Recurrent Melanoma, Recurrent Neuroblastoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Osteosarcoma, Recurrent Peripheral Primitive Neuroectodermal Tumor, Recurrent Rhabdoid Tumor, Recurrent Rhabdoid Tumor of the Kidney, Recurrent Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Recurrent Thyroid Gland Carcinoma, Recurrent WHO Grade 2 Glioma, Refractory Adrenal Gland Pheochromocytoma, Refractory Ependymoma, Refractory Ewing Sarcoma, Refractory Hepatoblastoma, Refractory Langerhans Cell Histiocytosis, Refractory Malignant Germ Cell Tumor, Refractory Malignant Glioma, Refractory Medulloblastoma, Refractory Melanoma, Refractory Neuroblastoma, Refractory Non-Hodgkin Lymphoma, Refractory Osteosarcoma, Refractory Peripheral Primitive Neuroectodermal Tumor, Refractory Rhabdoid Tumor, Refractory Rhabdoid Tumor of the Kidney, Refractory Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma, Refractory Thyroid Gland Carcinoma, Refractory WHO Grade 2 Glioma
COG APEC1621N - NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 Subprotocol of LOXO-292 in Patients with Tumors Harboring RET Gene Alterations
The NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) study, referred to as Pediatric MATCH, will match targeted agents with specific molecular changes identified using genomic sequencing technologies in refractory/recurrent tumors from children and adolescents with cancer. The NCI-COG Pediatric MATCH study (APEC1621) is considered one study under one IND consisting of a Master Version Control protocol, screening protocol component and multiple subprotocol components, with each component being contained in its own separate document. Each “component” consists of the protocol document and its associated informed consent document. The Master Version Control Protocol is the overarching administrative protocol that will keep an up-to-date record of the current version of the screening protocol component and each subprotocol component of Pediatric MATCH. Since each subprotocol component operates independently from the other subprotocol components contained in Pediatric MATCH, each has its own version date. Likewise, the screening protocol component has its own version date since changes in any of the subprotocols may not require changes in the screening protocol.
Emily Greengard
All
12 Months to 21 Years old
Phase 2
STUDY00001752
STUDY00001752
Inclusion Criteria:
• Patient must have enrolled onto APEC1621SC and must have been given a treatment assignment to MATCH to APEC1621N based on the presence of an actionable mutation
• Patients must be >= 12 months and =< 21 years of age at the time of study enrollment
• Patients must have radiographically measurable disease at the time of study enrollment. Patients with neuroblastoma who do not have measurable disease but have metaiodobenzylguanidine (MIBG) positive (+) evaluable disease are eligible. Measurable disease in patients with CNS involvement is defined as any lesion that is at minimum 10 mm in one dimension on standard MRI or CT
• Note: The following do not qualify as measurable disease:
• Malignant fluid collections (e.g., ascites, pleural effusions)
• Bone marrow infiltration except that detected by MIBG scan for neuroblastoma
• Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography [PET] scans) except as noted for neuroblastoma
• Elevated tumor markers in plasma or cerebral spinal fluid (CSF)
• Previously radiated lesions that have not demonstrated clear progression post radiation
• Leptomeningeal lesions that do not meet the measurement requirements for Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
• Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age. Note: Neurologic deficits in patients with CNS tumors must have been relatively stable for at least 7 days prior to study enrollment. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
• Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment. If after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately
• Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive.
• >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)
• Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil [ANC] counts): >= 7 days after the last dose of agent.
• Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1
• Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
• Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor. For growth factors that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the study chair and the study-assigned research coordinator
• Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)
• Stem cell infusions (with or without total body irradiation [TBI]):
• Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion and no evidence of graft versus host disease (GVHD)
• Autologous stem cell infusion including boost infusion: >= 42 days
• Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)
• Radiation therapy (XRT)/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation
• Note: Radiation may not be delivered to "measurable disease" tumor site(s) being used to follow response to subprotocol treatment
• Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131I-MIBG): >= 42 days after systemically administered radiopharmaceutical therapy
• Patients must not have received prior exposure to selpercatinib (LOXO-292) or other specific RET inhibitors
• For patients with solid tumors without known bone marrow involvement (within 7 days prior to enrollment):
• Peripheral absolute neutrophil count (ANC) >= 1000/mm^3
• For patients with solid tumors without known bone marrow involvement (within 7 days prior to enrollment):
• Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
• Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions). These patients will not be evaluable for hematologic toxicity
• Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2 (within 7 days prior to enrollment) or a serum creatinine based on age/gender as follows (within 7 days prior to enrollment):
• Age: Maximum serum creatinine (mg/dL)
• 1 to < 2 years: male (0.6), female (0.6)
• 2 to < 6 years: male (0.8), female (0.8)
• 6 to < 10 years: male (1), female (1)
• 10 to < 13 years: male (1.2), female (1.2)
• 13 to < 16 years: male (1.5), female (1.4)
• >= 16 years: male (1.7), female (1.4)
• Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment)
• Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L. (within 7 days prior to enrollment) (For the purpose of this study, the ULN for SGPT is 45 U/L.)
• Serum albumin >= 2 g/dL (within 7 days prior to enrollment)
• Corrected QT (QTc) interval =< 480 milliseconds (within 7 days prior to enrollment)
• All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines
Exclusion Criteria:
• Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use two (2) highly effective contraceptive method for the duration of study treatment and for at least 2 weeks after the last dose of selpercatinib (LOXO-292). Male study participants are to refrain from sperm donation during treatment and for 2 weeks after the last dose of selpercatinib (LOXO-292)
• Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible. If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
• Patients who are currently receiving another investigational drug are not eligible
• Patients who are currently receiving other anti-cancer agents are not eligible
• Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial
• Patients who are currently receiving drugs that are moderate or strong inducers or inhibitors of CYP3A4 are not eligible. Strong inducers or inhibitors of CYP3A4 should be avoided from 14 days prior to enrollment to the end of the study. Note: CYP3A4 inducing anti-epileptic drugs and dexamethasone for CNS tumors or metastases, on a stable dose, are allowed
• Proton pump inhibitors (PPIs), H2 receptor antagonists and antacids: Concomitant use of PPIs during selpercatinib (LOXO-292) therapy should be avoided if feasible. If co-administration of selpercatinib and PPI is necessary, administer selpercatinib with a meal. If H2 receptor antagonist is necessary, administer selpercatinib 2 hours before or 10 hours after H2 receptor antagonist administration. If antacid use is necessary, administer selpercatinib 2 or more hours before or 2 or more hours after antacid administration
• Patients who have major surgery within 14 days prior to cycle 1 day 1 (C1D1) are not eligible. (Central line placement or subcutaneous port placement is not considered major surgery)
• Patients with known clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of selpercatinib (LOXO-292) are excluded
• Patients with known hypersensitivity to any of the components of the investigational agent, LOXO 292 are excluded
• Patients with uncontrolled hypertension are excluded
• Patients with uncontrolled symptomatic hyperthyroidism and hypothyroidism (i.e. the patient required a modification to current thyroid medication in 7 days prior to enrollment) are excluded
• Patients with uncontrolled symptomatic hypercalcemia and hypocalcemia are excluded
• Patients who have an uncontrolled infection are not eligible
• Patients who have received a prior solid organ transplantation are not eligible
• Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible
Procedure: Computed Tomography, Procedure: Magnetic Resonance Imaging, Procedure: Positron Emission Tomography, Procedure: Radionuclide Imaging, Drug: Selpercatinib, Procedure: X-Ray Imaging
Hematopoietic and Lymphoid System Neoplasm, Recurrent Ependymoma, Recurrent Ewing Sarcoma, Recurrent Hepatoblastoma, Recurrent Histiocytic and Dendritic Cell Neoplasm, Recurrent Langerhans Cell Histiocytosis, Recurrent Lymphoma, Recurrent Malignant Germ Cell Tumor, Recurrent Malignant Glioma, Recurrent Malignant Solid Neoplasm, Recurrent Medulloblastoma, Recurrent Neuroblastoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Osteosarcoma, Recurrent Peripheral Primitive Neuroectodermal Tumor, Recurrent Rhabdoid Tumor, Recurrent Rhabdomyosarcoma, Recurrent Soft Tissue Sarcoma, Recurrent WHO Grade 2 Glioma, Refractory Ependymoma, Refractory Ewing Sarcoma, Refractory Hepatoblastoma, Refractory Histiocytic and Dendritic Cell Neoplasm, Refractory Langerhans Cell Histiocytosis, Refractory Lymphoma, Refractory Malignant Germ Cell Tumor, Refractory Malignant Glioma, Refractory Malignant Solid Neoplasm, Refractory Medulloblastoma, Refractory Neuroblastoma, Refractory Non-Hodgkin Lymphoma, Refractory Osteosarcoma, Refractory Peripheral Primitive Neuroectodermal Tumor, Refractory Rhabdoid Tumor, Refractory Rhabdomyosarcoma, Refractory Soft Tissue Sarcoma, Refractory WHO Grade 2 Glioma, Wilms Tumor
Geniculate Artery Embolization
This is a single center phase I and II study which is designed to initially assess the safety, and later the efficacy of geniculate artery embolization in reducing pain compared to a control group undergoing only conservative presurgical management. This study will consist of two phases, each with a 1 month preprocedural evaluation, day of treatment and 30 day follow up period for the first 10 participants and 6 month for the remaining 40 participants. 10 participants will be enrolled for the first phase, and 40 participants will be enrolled for the second phase at the University of Minnesota Medical Center. Enrollment is expected to take up to 6 months for each phase of the study. The collection of data will be accomplished by utilizing a clinical research team that will assess the efficacy and safety. Efficacy assessments will include; Joint injection intervals, MRI, X-ray, joint aspiration / serologies and patient questionnaires evaluating joint pain. Safety assessments include participant and investigator reported adverse events, vital signs, (blood pressure, heart rate, temperature), and physical exam.
Reza Talaie
All
40 Years to 70 Years old
N/A
STUDY00006202
STUDY00006202
Inclusion Criteria:
Unilaterally dominant symptomatic osteoarthritis (bilateral radiographic OA will not exclude)
Patients who are symptomatically refractory of at least 3 months of medical and/or rehabilitation measures (anti-inflammatory drugs, and/or physical therapy, and/or strength conditioning, and/or 0-1 intra-articular injections of the affected knee)
Kellgren-Lawrence grade 1, 2, or 3 on radiograph of the knee
Patients who are willing to comply with the protocol requirements and willing to undergo non-contrast MRI 1-30 days prior to procedure and at 12 months following procedure
Patients who are willing to comply with regular follow up during the 12 month follow-up period
Patients who have been evaluated by an orthopaedic surgeon or sports medicine provider and deemed to not be a current candidate for partial or total knee arthroplasty. These patients do, however, need to be considered a potential candidate for partial or total knee as an end point following the natural history of osteoarthritis.
Patients with WOMAC Score >=6 in at least 2 categories
Exclusion Criteria:
Patients with a weight >250 pounds
Patients with advanced peripheral arterial disease (resting ABI <= 0.9)
Patients with known significant peripheral arterial disease precluding common femoral catheterization
Patients who do smoke or have smoked tobacco regularly (smoking 1 or more tobacco product(s) per week) within the last year
Patients with diabetes who have a hemoglobin A1C of >9%
Patients who have undergone previous lower extremity embolization
Patients with uncontrolled emotional disorders per patient medical history
Patients with chronic pain syndrome or currently under a pain contract
Patients with anatomic variants involving the lower extremities which would increase the risk of non-target embolization
Patients with renal insufficiency based on an estimated GFR<45 ml/min who are not already on hemodialysis.
Patients with an abnormal INR (>1.5).
Patients with a platelet count <50x109/L.
Patients who are currently receiving medications for anticoagulation which cannot safely be held for the procedure and for 7 days post-procedure.
Patients with a known severe allergy to iodine which cannot be adequately pre-medicated
Patients who are pregnant or intend to become pregnant within 6 months of the procedure
Patients with a contraindication to drugs used for moderate sedation during interventional procedures, including Midazolam and Fentanyl
Patients with a life expectancy <60 months
Patients who are currently enrolled or who plan to enroll in other investigations that conflict with follow-up testing or confounds data in this trial
Patients with contraindications to medical and physical rehabilitative treatments of OA
Patients with known advanced atherosclerosis
Patients with known current or previous lower extremity fistula
Patients with rheumatoid arthritis or seronegative arthropathies
Patients with prior ipsilateral knee surgery.
Patients with WOMAC Pain Scale < 6
Patients having received more than one steroid injection in the affected joint or an injection in the affected joint within 3 months of screening Device: Geniculate Artery Embolization
Osteo Arthritis Knee, Arthritis, Osteoarthritis, Osteoarthritis, Knee
Clinics and Surgery Center (CSC)
Time Restricted Eating as a Viable Alternative to Caloric Restriction for Treating Hyperglycemia in a Population with Type 2 (T2DM) diabetes (SFS3)
Feasibility study to test our overall hypothesis that time restricted eating (TRE) presents a viable alternative to caloric restriction for improving glycemic measures and reducing weight in overweight/obese patients with metformin-only treated Type 2 diabetes (T2DM).
Lisa Chow
Male or Female
18 Years and over
N/A
STUDY00014853
STUDY00014853
Inclusion Criteria:
• Overweight/obese adults with metformin-only treated type 2 diabetes
• 18-65 years old
• BMI: 25-40 kg/m2 -HbA1c: 6.5-8.5%
• Self reported weight must be stable (+/- 5 pounds) for at least 3 months prior to the study
• owns a smartphone
Behavioral: Caloric reduction, Behavioral: Time restricted eating
Diabetes & Endocrine
time restricted eatin, Type 2 diabetes, diet intervention, intermittent fasting, caloric restriction
Effects of Music Based Intervention (MBI) on Neurodevelopment and Pain Response in Preterm Infants
Study design: Pilot prospective randomized, double blinded, controlled study to test effect of music based intervention (MBI) on pain response and neuro development in preterm infants. Aim 1: Characterize differences in preterm pain responses between MBI and controls.The objective of this aim is to understand the behavioral processes of MBI on pain in preterm infants by comparing the PIPP and EEG pain responses in the MBI and control cohorts. Aim 2: Identify differences between MBI and controls in preterm brain maturation and early neurodevelopment.The objective of this aim is to explore biological mechanisms of MBI on preterm brain maturation and neurodevelopment using electroencephalography (EEG) and event related potentials (ERPs).
Sonya Wang
All
28 Weeks to 32 Weeks old
N/A
STUDY00008369
STUDY00008369
Inclusion Criteria:
Preterm infant born at 30 weeks (+/- 2 weeks)
Medically stable
Exclusion Criteria:
Treatment for major organ system disease
Significant neurological disorder including, but not limited to, abnormal neurological examination, neonatal abstinence syndrome, intraventricular hemorrhage, seizures, meningitis, or congenital brain malformations
Scalp lesions affecting EEG placement Other: Music Based Intervention, Other: Sham Treatment
Children's Health
Music Based Intervention, Preterm Infant Pain Profile
MT2014-10C : Allogeneic Hematopoietic Stem Cell Transplant for Patients with High Risk Hemoglobinopathies and Other Red Cell Transfusion Dependent Disorders
Ashish Gupta
All
to 55 Years old
N/A
1407M52125
1407M52125
Inclusion Criteria:
Diagnosis of Sickle Cell Disease, Thalassemia, Diamond Blackfan Anemia or other non-malignant hematologic disorders for which a stem cell transplant is indicated
Acceptable stem cell source identified
Performance status of ≥ 70% (Karnofsky),or ≥ 70 (Lansky play score)
Creatinine <2.0 mg/dl for adults or glomerular filtration rate > 50 ml/min for children
Bilirubin, Aspartate Aminotransferase, Alkaline phosphatase <5 times the upper limit of institutional normal
Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction > 40%
Exclusion Criteria:
active, uncontrolled infection
pregnant or breastfeeding
HIV positive Drug: Myeloablative Preparative Regimen, Drug: Reduced Intensity Preparative Regimen, Drug: Reduced Toxicity Ablative Regimen
Sickle Cell Disease, Transfusion Dependent Alpha- or Beta- Thalassemia, Diamond Blackfan Anemia, Paroxysmal Nocturnal Hemoglobinuria, Glanzmann Thrombasthenia, Severe Congenital Neutropenia, Shwachman-Diamond Syndrome, Non-Malignant Hematologic Disorders
Clinics and Surgery Center (CSC)
Understanding the long term impact of COVID-19 on the brain by advanced MR imaging and spectroscopy
In this study, we want to learn more about what kinds of structural and chemical changes are happening in the nervous systems of people recovering from COVID-19 compared to people who have not been exposed to COVID-19.
Gulin Oz
Male or Female
18 Years and over
STUDY00012571
STUDY00012571
Inclusion Criteria:
• Participants must be 18 years or older
• Participants must fall into one of the following groups: a) no known COVID-19 exposure (for controls), or b) laboratory confirmed COVID-19 who present with neurological symptoms in the months after infection and were either 1) non-hospitalized, or 2) hospitalized, but never underwent invasive (tube in throat) ventilation
• Participants must be English or Spanish speaking
• Participants must be able to provide written informed consent
• Participants must be clear of any contraindications for MRI (see exclusions) *Study not registered on Clinicaltrials.gov
Exclusion Criteria:
• Medical conditions likely to interfere with the study, including chronic neurologic conditions (such as Alzheimer disease, Parkinson's disease, ALS, HIV-Associated Neurocognitive Disorder, brain infections, or brain tumors), traumatic brain injury with loss of consciousness, end-stage kidney disease, end-stage liver disease, restless leg syndrome, chronic lung disease unrelated to COVID-19 needing oxygen, history of stroke unrelated to COVID-19, history of bipolar disorder or psychotic illness (such as schizophrenia or schizoaffective disorder)
• Individuals who had COVID-19 and required mechanical invasive ventilation
• Pregnant women
• Inability to undergo MRI scanning, including but not limited to claustrophobia, unable to remain still in an MRI scanner for more than 30 minutes, presence of metallic foreign bodies or pacemakers in body, weight over 350 lbs. *Study not registered on Clinicaltrials.gov
Brain & Nervous System, COVID-19
CMRR, COVID-19, Coronavirus, MRI, MRS, SARS-CoV-2, long COVID, long-term, neurological
A Multi-Center, Open-Label, Randomized Phase 3 Trial Comparing the Safety and Efficacy of 177Lu-PSMA-I&T versus Hormone Therapy in Patients with Metastatic Castration-Resistant Prostate Cancer.
This is a prospective, randomized, open-label, multicenter Phase 3 study evaluating the efficacy and safety of 177Lu-PSMA-I&T versus a switch in standard of care hormone therapy in men with metastatic castration-resistant prostate cancer (mCRPC)
Gautam Jha
Male
18 Years to old
Phase III
STUDY00014801
STUDY00014801
Inclusion Criteria:
Male 18 years or older able to understand and provide signed written informed consent.
Histologically or pathologically confirmed prostate adenocarcinoma without predominant small cell component.
Progressive disease by one or more of the following criteria:
Serum/plasma PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week apart with a minimum start value of >2 ng/mL.
Progression of measurable disease (RECIST 1.1) or presence of at least two new bone lesions (PCWG3 criteria).
Previous treatment with next-generation androgen receptor (AR)-directed therapy (e.g. abiraterone, enzalutamide, apalutamide, darolutamide).
Must have received no more than one previous AR-directed therapy.
Must have been administered ARAT (abiraterone, enzalutamide, darolutamide, or apalutamide) in the castration-sensitive or castration-resistant setting.
Must have progressed while on ARAT.
PSMA-PET scan (e.g., 68Ga-PSMA-11 or 18F-DCFPyL) positive as determined by central reader.
Effective castration with serum testosterone level of <50 ng/dL and plan to continue with chronic medical or surgical castration.
Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
Patients with HIV that are healthy and with a low risk of acquired immune deficiency syndrome related outcomes may participate in the trial at the investigators' discretion.
Patients with HBV and HCV may also participate if symptoms are sufficiently managed.
Life expectancy of at least 6 months as assessed by investigator.
Willing to initiate ARAT therapy determined by investigator.
For patients who have partners of childbearing potential: The patient and/or partner must use a method of birth control with adequate barrier protection, deemed acceptable by the principal investigator during the study and for 6 months after the last study drug administration.
Exclusion Criteria:
Prior treatment with radioligand therapy including other lutetium-labeled compounds.
Prior treatment with radium-223 (Xofigo) within the past 12 weeks.
Prior chemotherapy treatment for castration-resistant prostate cancer. Prior docetaxel use in the hormone-sensitive setting is permitted, as long as no more than 6 doses were received, the last dose was administered >1 year prior to consent, and disease progression did not occur during docetaxel treatment.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≥ 2
Patients with known HRR gene-mutation who have not been previously treated with olaparib or rucaparib.
Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy.
Inadequate organ and bone marrow function as evidenced by:
Hemoglobin < 8 g/dL.
Absolute neutrophil count < 1.5 x 109/L.
Platelet count < 100 x 109/L.
AST/SGOT and/or ALT/SGPT > 3.0 x ULN.
Total bilirubin > 2 x ULN unless patient has known Gilbert's syndrome and then may be 3 x ULN.
Creatinine clearance (CrCl) < 50 mL/min based on the Cockcroft-Gault equation.
Albumin ≤ 2.75 g/dL
Patients who undergo a transfusion for the sole purpose of meeting eligibility for this trial will be excluded.
Assessment by the Investigator as unable or unwilling to comply with the requirements of the protocol.
Use of an investigational therapeutic drug within the last 4 weeks prior to start of study treatment or scheduled to receive one during the study period.
Known CNS metastasis unless received therapy, asymptomatic and neurologically stable.
Patients receiving zoledronic acid for bone-targeted therapy must be on stable dose for 4 weeks prior to randomization.
Major surgery within 30 days of randomization as determined by the Investigator.
Patients with active significant cardiac disease defined by any of the following:
New York Heart Association class 3 or 4 congestive heart failure within 6 months of signing the ICF unless treated with improvement.
Current diagnosis of electrocardiogram abnormalities with significant cardiac arrhythmias
History of long QT syndrome or know history of Torsades de Pointe
History of myocardial infarction, angina pectoris, or coronary artery bypass graft within 6 months of ICF signature
Participants with symptomatic cord compression or clinical/radiological findings indicating impending spinal cord compression
Patients with a superscan seen on baseline bone scan as determined by investigator.
Active malignancy other than low-grade non-muscle-invasive bladder cancer and non-melanoma skin cancer
Previous use of G-CSF for persistent neutropenia after standard of care treatment.
Participants who have a pregnant partner or are capable of fathering a child and who are unwilling to take precautions to prevent potential harm to the fetus or prevent pregnancy.
Participants with active Covid19. Recovered patients may be included when completely recovered (no symptoms at least 28 days before study medication and a negative Covid test within 72 hours). Drug: 177Lu-PSMA-I&T, Drug: Abiraterone with Prednisone or Enzalutamide
Cancer
Prostate Cancer, Clinics and Surgery Center (CSC)
Quality of life in patients who have undergone different treatments for upper airway stenosis
The objective of the study is to define quality of life in patients with upper airway stenosis after bypassing the stenosis with either tracheotomy or t-tube stenting. Participants complete surveys over 2 years to collect quality of life information.
Raluca Gray
Male or Female
18 Years and over
STUDY00015986
STUDY00015986
Inclusion Criteria:
Diagnosis: upper airway stenosis
with tracheotomy or t-tube.
Seen at the Lions Voice Clinic.
Ability to provide informed
consent.
Ability to complete questionnaires in English by
themselves.
Exclusion Criteria:
<18 years old.
Mechanical
ventilation.
Neurological
co-morbidity such as stroke, cerebral palsy, neurodegenerative disease.
New diagnosis (<1
year) of head and neck cancer as the indication for tracheotomy. Breathing, Lung & Sleep Health, Ear, Nose & Throat
Montgomery t-tube, airway stenosis, stenosis, t-tube, trach, tracheotomy, Clinics and Surgery Center (CSC)
Safety and Acceptability of Patient -administered Sedation During Mechanical Ventilation
The primary objective of the study is to assess the efficacy of patient controlled sedation (Self-management of sedative therapy) using dexmedetomidine to reduce anxiety, delirium incidence and duration of mechanical ventilation compared to usual sedation practices in mechanically ventilated subjects.
Craig Weinert
All
18 Years to old
Phase 2/Phase 3
1605M88241
1605M88241
Inclusion Criteria:
Subject is acutely mechanically ventilated during the current hospitalization.
Subject is currently receiving a continuous intravenous infusion of a sedative/opioid medication(s) or has received at least one intravenous bolus dose of a sedative/opioid medication in the previous 24 hours (fentanyl, hydromorphone, ketamine, morphine, midazolam, diazepam, lorazepam, propofol, haloperidol, dexmedetomidine).
Subject must pass pre-Patient-Controlled Sedation (PCS) screening test and be assessed Richmond Agitation-Sedation Scale (RASS) -2 to +1
Subject Age ≥ 18 years
Subject or their proxy is capable of providing informed consent
Exclusion Criteria:
Aggressive ventilatory support or prone ventilation.
Hypotension (systolic blood pressure < 85 mmHg) requiring a vasopressor at a dose greater than norepinephrine or epinephrine 0.15 mcg/kg/min or vasopressin > 2.4 units per hour. Subjects will be excluded if they require more than one continuous infusion of a catecholamine vasopressor medication simultaneously. Subjects will be excluded if the vasopressor dose was higher than norepinephrine or epinephrine 0.15 mcg/kg/min, vasopressin > 2.4 units per hour, phenylephrine >3 mcg/kg/min, dopamine >10 mcg/kg/min or dobutamine at any dose in the prior 6 hours. If dopamine is being used to increase heart rate, rather than as a vasopressor for hypotension, subject will be excluded.
Second or third degree heart block or bradycardia (heart rate < 50 beats/min).
Paralysis or other condition preventing the use of push button device
Positive pregnancy test or lactation
Acute hepatitis or liver failure (direct bilirubin >5 mg/dL)
Acute stroke or uncontrolled seizures.
Acute myocardial infarction within 48 hours prior to enrollment.
Severe cognition or communication problems (such as coma, deafness without signing literacy, physician-documented dementia)
Assessed RASS -3, -4, -5 or RASS +2,+3, +4
Chronic ventilator support in place of residence prior to current hospitalization.
Imminent extubation from mechanical ventilator support. Drug: Dexmedetomidine
Critical Illness, Anxiety, Respiratory Failure
The effects of cigarette smoking and alcohol on DNA damage in the oral cavity
The purpose of this study to examine the effects of cigarette smoking and drinking alcohol on the formation of DNA damage in the mouth. The overall goal is to identify DNA damage that may be important to the development of cancer.
Stephen Hecht, PhD
Male or Female
18 Years and over
STUDY00014570
STUDY00014570
Inclusion Criteria:
• Daily cigarette smoker
• 21 years of age or older
• Non-drinkers and alcohol drinkers
Prevention & Wellness
Smoking, alcohol, cigarettes, drinking, tobacco
20-0001: A Phase 1b/2, Multi-Centered, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Microbiological Activity of a Single Dose of Bacteriophage Therapy in Cystic Fibrosis Subjects Colonized with Pseudomonas aeruginosa
This clinical trial is designed to describe the safety and microbiologic activity of bacteriophages directed at P. aeruginosa in clinically stable CF subjects with P. aeruginosa respiratory colonization. This is a dose-ranging study of IV anti-pseudomonal bacteriophage therapy.
Joanne Billings
All
18 Years to 99 Years old
Phase 1/Phase 2
STUDY00013957
STUDY00013957
Inclusion Criteria:
Subjects must meet all the inclusion criteria to be eligible to participate in the study:
Adult (>/= 18 years) at the time of screening.
Confirmed CF diagnosis based on a compatible clinical syndrome confirmed by either an abnormal sweat chloride testing or CFTR gene variations.*
*Can be obtained from documentation in medical records; actual test results not necessary.
Likely able to produce at least 2 mL of sputum during a 30-minute sputum collection following a hypertonic saline treatment or other approach to increase sputum production.*
**Determined by investigator or their designee judgement. Approaches for obtaining sputum may include, but are not limited to, inhaled hypertonic saline (e.g. 3%, 7%, or 10%), inhaled hypertonic bicarbonate, inhaled mannitol, or spontaneously expectorated sputum. The same approach is recommended, whenever possible, for all sputum collections for a given subject.
P. aeruginosa (regardless of Colony Forming Units (CFU)/mL) isolated from a sputum, throat culture, or other respiratory specimen in the past 12 months.
Confirmed P. aeruginosa isolation from a sample of expectorated sputum at the Screening Visit.
Capable of providing informed consent.
Capable and willing to complete all study visits and perform all procedures required by the protocol.
Exclusion Criteria:
Subjects who meet any of the exclusion criteria will not be enrolled in the study:
Body weight < 30 kg.
Forced Expiratory Volume 1 second < 20% of predicted value at screening, using the Hankinson equations.
Elevated LFTs obtained at screening.*
*a. Alanine aminotransferase (ALT) > 5 x the upper limit of normal (ULN) or aspartate transaminase (AST) > 5 x ULN or total bilirubin > 3 x ULN, OR b. Total bilirubin > 1.5 x ULN combined with either ALT > 3 x ULN or AST > 3 x ULN. ULN reflects local laboratory ranges.
Acute clinical illness requiring a new (oral, parenteral), or inhaled antibiotic(s) 45 years old and has gone at least 12 months without a spontaneous menstrual period without other known or suspected cause.
Effective methods of contraception include (a) abstinence, (b) partner vasectomy, (c) intrauterine devices, (d) hormonal implants (such as Implanon), or (e) other hormonal methods (birth control pills, injections, patches, vaginal rings).
Active treatment of any mycobacterial or fungal organisms Other: Placebo, Biological: WRAIR-PAM-CF1
Rare Diseases
Bacteriophage therapy, Cystic Fibrosis, Microbiological Activity, Pseudomonas aeruginosa, Safety
Implementing Personalized Exercise Prescriptions through Mobile Health in the Rural Elderly Cancer Survivors
This study is to examine the effects of combination of a smartwatch and a Facebook health education intervention on cancer survivors’ physical activity (daily steps) through personalized exercise prescriptions, as compared to smartwatch only, Facebook only, and attention control conditions.
Zan Gao, Ph.D.
All
50 Years to old
N/A
STUDY00012600
STUDY00012600
Inclusion Criteria:
Have had one or more of the cancers of interest (i.e., breast, colon, bladder, prostate, endometrium, esophagus, lung, kidney & renal pelvis, stomach)
Complete active cancer treatment at least three months prior to enrollment, with the exception of anti- hormonal therapy
Possess an Android or Apple smartphone
Having a Facebook account, or are willing to make one
Engage in some type of physical activity (PA) as assessed by PA readiness survey.
Exclusion Criteria:
Diagnosed with stage IV cancer
Completed primary cancer treatment (e.g., surgery, radiotherapy) less than six months ago with new cancer diagnosis or recurrence Behavioral: Facebook Health Education, Behavioral: Personalized Smartwatch
Cancer
Post-operative Sore Throat and Gum Chewing for Long Duration LMA Use
The purpose of this study is to determine if chewing gum immediately prior to transport to the operating room reduces the severity of post-operative sore throat in patients who have an LMA placed for procedures with duration greater than 1 hour.
Jacob Hutchins
All
18 Years to 75 Years old
N/A
STUDY00012614
STUDY00012614
Inclusion Criteria:
Outpatient ambulatory surgery
General anesthesia utilizing a laryngeal mask airway
Greater than 1 hour duration
Exclusion Criteria:
Chronic laryngitis
Chronic bronchitis
Asthma
Gastroesophageal reflux disease
Smoking within the last week
Non-English speaking Other: Control, Other: Gum
Anesthesia, Surgery
Clinics and Surgery Center (CSC)
Assessment of Complete Pathologic Response After Neoadjuvant Chemotherapy for Breast Cancer
We are studying women who have triple negative or HER2 positive breast cancer and have received chemotherapy before surgery. We will do a breast MRI, with or without a biopsy, to see if results can predict if the cancer is completely gone.
Todd Tuttle, MD
Female
18 Years to old
STUDY00006873
STUDY00006873
Inclusion Criteria:
Biopsy proven triple negative (TN) (ER-/PR-/HER2-) or HER2 positive (ERany/PRany/HER2+) breast cancer for which neoadjuvant chemotherapy is planned
A biopsy clip placed at the time of diagnostic biopsy
18 years of age or older
Must be able to read and write in English due to the importance of survey (questionnaire) completion to meet the study's endpoint - this is justified as there is no individual benefit to study participation
Able to provide written consent prior to any research related activities
Exclusion Criteria:
Stage IV breast cancer
T4 breast cancer
Previous ipsilateral breast cancer
Any contraindication for undergoing a contrast-enhanced breast MRI and/or the breast biopsy between chemotherapy and surgery Radiation: Standard Trimodality Breast Imaging
TN ER-/PR-/HER2- Breast Cancer, Triple Negative Breast Cancer, HER2-positive Breast Cancer, ERany/PRany/HER2+ Breast Cancer
Breast Cancer
State Representation in Early Psychosis (STEP)
Our Center will focus on the unifying hypothesis that processes underlying state representation dysfunction are relevant to psychosis, providing a window into pathophysiologic heterogeneity and precision treatment. Our Center will study three species (nonhuman primates, mice, and humans) using eight methodologies (genetic manipulations, slice physiology, ensemble recordings, LFP, behavior, EEG, fMRI, cognitive training). We will use a central computational perspective to translate and integrate across species and methodologies: Changes in neural information processing that affect parameters underlying attractor dynamics and influence state representation processes. Such changes create observable effects in behavior and neurophysiology, which we will study through the lens of attractor network models to inform our understanding of pathophysiologic heterogeneity, clinical trajectories, and precision treatment.
Sophia Vinogradov
Male or Female
Not specified
N/A
STUDY00009964
STUDY00009964
Inclusion Criteria:
English proficiency, as determined by staff observation and participant self-report
Estimated IQ at or above 70, as estimated by the cognitive assessments
Additional Inclusion Criteria for Early Psychosis Participants:
Clinical diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, psychosis NOS, bipolar disorder with psychosis, or major depressive disorder with psychosis, with onset of psychotic symptoms within the previous 5 years
Achieved clinical stability, defined as outpatient status for at least one month prior to study participation plus clinically stable doses of psychiatry medications for at least one month prior to study participation
Exclusion Criteria:
Unable or unwilling to provide informed consent
The participant is unable to demonstrate adequate decisional capacity, in the judgment of the consenting study staff member, to make a choice about participating in the research study
Participant is pregnant
Participant is illiterate
Cannot pass the CMRR Subject Safety Screen due to MRI contraindications
Presence of a major neurological disorder
Previous clinically significant head injury or prolonged unconsciousness, as determined by the PI/Co-Is
Meets criteria for substance or alcohol dependence within 3 months of enrollment
The presence of any major medical condition that, in the opinion of the PI/Co-Is, would impede participation in the study or would put the participant at additional risk by participating
Additional Exclusion Criteria for Early Psychosis Participants:
Has participated in significant formal cognitive training programs, as determined by the PI/Co-Is
Meets criteria for clinical risk of suicidal behavior, as defined by:
Clinician judgement
A suicide attempt within 6 months of enrollment
Active suicidal ideation at screening or baseline, as indicated by the C-SSRS
Previous intent to act on suicidal ideation with a specific plan and/or preparatory acts within 6 months of enrollment, as indicated by the C-SSRS
Additional Exclusion Criteria for Control Participants:
Meets DSM-5 criteria for psychotic, bipolar, or autism spectrum disorder
Has a family history (1st degree relative) of psychotic, bipolar, or autism spectrum disorder Device: Computerized Cognitive Training
Mental Health & Addiction
Wearable sensors for the combined use of early detection of postural instability and fall risk prediction in Parkinson s disease patients
This is a prospective study aimed at quantifying walking and balance in patients with parkinsonism in the clinical setting in addition to a living environment setting. To accomplish this, we will use a portable motion capture system that is widely used to study biomechanics in humans. Once quantified, we want to test the effects of deep brain stimulation (DBS) frequency in patients who already have DBS systems in place. Thus, our objectives are: 1. Demonstrate that parkinsonism patient-specific kinematics can be used to detect postural instability in the clinic using wearable IMUs. 2. Demonstrate that individualized, home-based postural response curves can detect postural instability and prospectively predict fall risk in patients with parkinsonism.
Robert McGovern, MD
Male or Female
18 Years and over
STUDY00007441
STUDY00007441
Inclusion Criteria:
• Anyone who has been diagnosed with parkinsonism including Parkinson?s disease, Normal Pressure Hydrocephalus, or atypical parkinsonism 2. Healthy adults of similar age as study participants 3. Ability to give informed consent
Exclusion Criteria:
• People who have dementia of sufficient severity to impair their ability to make health-care decisions for themselves
Brain & Nervous System
Deep Brain Stimulation (DBS), Falls, Parkinson's Disease
Maternal Metabolism, Breastmilk Composition, and Transmission to Infants
This is a pilot prospective cohort study of the differences between women with and without diabetes during pregnancy in their breast milk composition (microbiome and hormone composition), and test for group differences in the relationship of breast milk composition to infant gut microbiome characteristics, weight gain, and body composition. Women with diabetes during pregnancy (N=50) will be recruited de novo in this study, while women without diabetes (N=100) already have been enrolled and have provided consent for all necessary data involved in the comparison with the diabetic women, except that the non-diabetic women have not provided consent for the meta-genomic sequencing analysis and so will provide that consent under this protocol.
Ellen Demerath
All
STUDY00002127
STUDY00002127
Inclusion Criteria:
(For new enrollment of 50 pregnant women with gestational diabetes and their infants. Enrollment of normal weight and obese cohort comparators already accomplished under ClinicalTrial NCT03301753):
Pregnant women
age 21-45 at time of delivery
report during enrollment procedures that they have social support for and intention to exclusively breastfeed for at least 3 months (breastfeeding intentions are known to be correlated with actual behavior), and if parity >1, that they successfully breastfed after a previous pregnancy for at least 3 months
singleton pregnancy
known gestational diabetes Definition of Gestational Diabetes: 1) an elevated glucose challenge test >200 mg/dL or 2) two abnormal values on the glucose tolerance test according to Carpenter-Coustan criteria.
Exclusion Criteria:
alcohol consumption >1 drink per week during pregnancy/lactation
tobacco consumption during pregnancy/lactation,
inability to speak/understand English
known congenital metabolic, endocrine disease, or congenital illness affecting infant feeding
planned delivery at a site other than the University of Minnesota Medical Center- West Bank campus.
preexisting diabetes Obesity, Diabetes, Gestational
Obesity, Gestational Diabetes, Breast Milk, Microbiome, Infant Growth
Nornicotine in Smokeless Tobacco as a Precursor for Carcinogen Exposure
Smokeless tobacco users who are unable or unwilling to quit tobacco use may be exposed to the potent oral and esophageal carcinogen NNN not only from tobacco itself, but also via its endogenous synthesis from nornicotine. The proposed study will lead to an understanding of the endogenous formation of NNN from nornicotine in humans, and will also investigate the effect of the reduction of nornicotine content in smokeless tobacco on the extent of endogenous NNN formation. The knowledge gained in this study will lead to the development of recommendations for the regulation, or potentially elimination, of nornicotine in smokeless tobacco products in order to minimize exposure to NNN in the users of these products.
Irina Stepanov
All
18 Years to 65 Years old
NA
STUDY00002464
STUDY00002464
Inclusion Criteria:
Male or female adult smokeless tobacco users 18-65 years of age, using at least 3 tins of product per week for 6 months;
Used the same brand for >80% of their smokeless tobacco use over the course of at least 6 months, and used this brand exclusively for at least two weeks prior to the eligibility screening;
Not smoking or using any other nicotine or tobacco product in the past 2 weeks (expired CO < 6 ppm);
Participants are in good physical health (no unstable medical condition) and good general oral health as determined by the licensed medical professional;
Participants are in stable, good mental health (e.g. not currently, within the past 6 months, experiencing unstable or untreated psychiatric diagnosis, including substance abuse) as determined by the licensed medical professional;
Participants who are not taking any medications that affect relevant metabolic enzymes;
Women who are not pregnant or nursing or planning to become pregnant;
Participants have provided written informed consent to participate in the study.
Exclusion Criteria:
Significant immune system disorders, respiratory diseases, kidney or liver diseases or any other medical disorders that may affect biomarker data as determined by the licensed medical professional;
Vital signs out of range as determined by the licensed medical professional (participants failing for vital signs will be allowed to re-screen once):
Evident poor oral health (significant gum recession, dental caries, tooth loss) as determined by the general oral health status check;
Excessive drinking (e.g., 5 or more drinks daily) or problems with drinking or drugs (e.g., self-report of binge drinking alcohol or treatment for drug or alcohol abuse within last 3 months); to be assessed by PI or licensed medical professional;
Regular smoking or tobacco use (e.g., greater than once a week) other than oral smokeless tobacco products;
Currently (within the past 2 weeks) using nicotine replacement or other tobacco cessation products (to minimize confounding effects of another product); Drug: Herbal Snuff (Smokeless Tobacco)
Smokeless Tobacco
Brain Connectivity Patterns in Chronic Temporomandibular Joint Disorders
The purpose of the study is to assess sensory and pain processing, as well as brain anatomical and functional characteristics of individuals with chronic TMD pain and compare them to matched pain-free controls. Mechanisms of chronic TMD pain are poorly understood which prevents development of effective treatments, resulting in continued patient suffering and significant healthcare costs. Chronic TMD patients have been observed to share risk factors with other chronic pain patients that include physical, physiological, psychosocial and neurobiological components. Results of this study are expected to improve our understanding of the underlying disease processes involved in chronic TMD pain and will support the development of improved clinic treatments for the patients suffering from chronic pain.
Estephan Moana-Filho
Female
18 Years and over
STUDY00013924
STUDY00013924
Inclusion Criteria:
• Female participants only (biological sex)
• Age between 18-65 years
• Pain-free participants OR
• Chronic jaw pain ( > 3 months)
Exclusion Criteria:
• Certain medical conditions (examples: heart disease, diabetes, autism, trigeminal neuralgia)
• Any MRI contraindications (examples: metal implants, claustrophobia)
• Being left-handed only
Bone, Joint & Muscle, Brain & Nervous System, Dentistry
Chronic Jaw Pain, Functional Brain Imaging, Sensory Testing, Temporomandibular Disorders
Modifying Progesterone and Estradiol Levels to Prevent Postpartum Cigarette Smoking Relapse and Reduce Secondhand Smoke Exposure in Infants and Children
We will conduct a double-blind, placebo-controlled, randomized clinical trial at two sites to enhance the diversity of the study sample and generalizability of the results. We will enroll healthy pregnant women (n=320) who have recently quit smoking and intend to stay abstinent postpartum. Using a 2×2 factorial design, participants will be randomized into one of four assignments: (1) Prog + DMPA, (2) Prog + placebo, (3) placebo + DMPA, and (4) placebo + placebo. Participants will be followed for days to smoking relapse (primary outcome), smoking relapse-related risk factors (e.g., craving), and infant health outcomes from gestational week 36 through 9 months postpartum. This study proposes a safe and innovative intervention to examine the impact of manipulating postpartum physiological to influence the behavior of a new mother which will lead to improved health outcomes for her and her infant. The implications of this novel study will directly advance the current state of the science by expanding on the role of Prog and DMPA in addressing smoking-related behaviors within this highly vulnerable population. Further, should our central hypothesis be supported, the clinical translatability of this intervention is high and may be immediately pursued.
Sharon Allen, PhD
Female
18 Years to 40 Years old
Phase 4
STUDY00010569
STUDY00010569
Inclusion Criteria:
ability to provide informed consent,
aged 18 to 40 years old (women who smoke are at increased risk for early menopause, 62 which may result in different hormonal patterns during the postpartum period; to avoid this confounder, women over 40 will be excluded),
stable physical and mental health with either (a) a confirmed, uncomplicated pregnancy at gestational week 30or beyond, or (b) self-report the birth of a child within the past two years
Pregnant individuals only: established prenatal care with written approval to participate fully in the study from their prenatal healthcare provider,
history of ≥ 3 cigarettes a day during the six months prior to pregnancy
self-report of motivation to remain abstinent after delivery ≥ 7 on a 10 point Likert-type scale, and
willingness to use non-hormonal forms of contraceptives postpartum if sexually active during the 13-week study medication treatment period.
Exclusion Criteria:
current daily use of nicotine replacement therapy or smoking cessation medications,
current major depressive disorder based on the Patient Health Questionnaire-9 (PHQ-9) and the Beck Depression Inventory,
Postpartum individuals only: current use of exogenous hormones (including hormonal contraceptives),
contraindication to progesterone treatment (e.g., current use of drugs that may inhibit CYP3A4; current or history of deep vein thrombosis, pulmonary embolus, clotting or bleeding disorder, hypertension, stroke, heart disease, or liver dysfunction or disease; or peanut allergy),
current use of illicit drugs or alcohol abuse,
treatment for illicit drug use or alcohol use disorder within the last 3 months, and
any condition that, in the opinion of the clinical team, precludes participation in the trial. Other: Placebo Oral Tablet, Drug: Progesterone 200 MG Oral Capsule
Smoking, Smoking Cessation, Smoking Reduction
Mechanisms of diseases of the human immune system
Some immune-mediated diseases occur due to mutations in single genes (monogenic immune-mediated diseases) or a small number of genes. The hypothesis is that some patients with immune-mediated diseases (e.g. immunodeficiencies, autoinflammatory diseases, and autoimmune diseases) have genetic causes of their disease that have not yet been characterized at the genetic or molecular level, and that genetic sequencing or molecular and/or cellular analysis of samples from such patients will lead to diagnosis of novel immune-mediated diseases and/or increased understanding of novel or rare immune-mediated diseases. To achieve this, there remains the need for exploratory data collection that will further future research, including possible confirmatory trials. Based on the exploratory nature of this study design this study looks to these objectives: • The primary objective is to determine the genetic and molecular pathways driving a patient’s immune-mediated disease. • The secondary objective is to improve understanding of the molecular pathways of a patient’s disease, which may lead to improved therapy for that patient or similar patients. Study intervention will include specimen (blood, urine and if applicable, skin biopsy), clinical data and medical history in affected patients and unaffected or affected family members.
Bryce Binstadt
Male or Female
Not specified
STUDY00005699
STUDY00005699
Inclusion Criteria:
• Patients with defined immune-mediated diseases or suspected immune-mediated diseases who have completed genetic testing and counseling as part of clinical care.
• Family members of enrolled participants may also be recruited.
• Healthy controls may also be enrolled as a comparison group.
Exclusion Criteria:
• Neonates (<1 month old)
• Adults lacking the capacity to consent
Immune Diseases, Rare Diseases
autoimmune diseases, autoinflammatory diseases, genetic sequencing, immune-mediated diseases