Search Results Within Category "Cancer"
Suggestions within category "Cancer"
MT2019-09: A randomized trial of low versus moderate exposure busulfan for infants with severe combined immunodeficiency (SCID) receiving TCR alpha beta +/CD19+ depleted transplantation: A Phase II study by the Primary Immune Deficiency Treatment Consortium (PIDTC) and Pediatric Blood and Marrow Transplant Consortium (PBMTC) PIDTC CSIDE Protocol (CSIDE)
We want to study if lower doses of a chemotherapy drug called busulfan will help babies with SCID achieve good immunity with less short and long-term risks of complications after transplantation. This trial identifies babies with types of immune deficiencies that are most likely to succeed with this approach and offers them transplant early in life before they get severe infections or later if their infections are under control. It includes only patients receiving unrelated or mismatched related donor transplants.
• 0 to 2 years old
• infants with SCID, either typical or leaky or Omenn syndrome
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• any serious life-threatening or opportunistic infection at time of enrollment
• HIV or HTLV I/II infection
I-SPY 2 TRIAL -Investigation of Serial Studies to Predict your Therapeutic Response with Imaging and Molecular Analysis 2 (I-SPY)
The I-SPY2 study uses 10 years of results to help your doctor understand more about your tumor and how to classify it better. This means your doctor will have more information and might be able to offer you a new treatment that could work better than the usual treatments. We need better treatments and better ways to identify which patients will benefit most from particular treatments.
• invasive breast cancer confirmed by biopsy
• tumor is at least 2.5 cm in size
• no prior chemotherapy for this cancer
• no restrictions in activity or partially restricted with work, but able to independently care for self
• willing to have another breast biopsy
• not pregnant or breast feeding
• consult study staff for additional requirements
• other medical or mental health diagnosis that would limit compliance with study requirements
A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer (EMBER-4)
Disruption of estrogen signaling by drugs called selective estrogen receptor degraders (SERDs) is one of the treatment options for patients with estrogen receptor positive (ER+) cancers. Imlunestrant is a SERD that disrupts estrogen signaling, and therefore should stop or slow down tumor growth in ER+ cancers. This study will help answer research questions about the safety of imlunestrant and any side effects, and how imlunestrant compares to standard-of-care endocrine therapy.
• diagnosis of ER+, HER2- early-stage invasive breast cancer without evidence of distant metastasis
• completed surgery
• received at least 24 months but not more than 60 months of any endocrine therapy after treatment
• may be limited with strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• any evidence of metastatic disease
• more than a 6 month consecutive gap in therapy during the course of prior adjuvant endocrine therapy
• history of any other cancer
• women who are pregnant, breastfeeding, or expecting to conceive or men expecting to father children
MT2022-44 Analysis of Autoinflammation in Chronic Granulomatous Disease Patients Undergoing Hematopoietic Cell Transplantation or Gene Therapy (PIDTC 6908)
CGD disorders are a group of diseases that cause the immune system to function abnormally, leading to infections, autoimmunity and/or inflammation that can begin early in life. CGD is usually caused by changes in certain genes in DNA. Researchers are trying to learn what types of medical problems patients with CGD have and how these respond to treatment, including bone marrow transplantation and gene therapy. Researchers also want to learn which genes cause CGD and how specific gene abnormalities lead to medical problems.
• confirmed diagnosis of Chronic Granulomatous Disease (CGD)
• to be scheduled to undergo HCT or GT within one year of enrollment
• additional inclusion criteria (study staff will review)
• .presence of other primary immunodeficiency syndromes that do not meet the clinical and laboratory criteria for CGD
• HIV infection
• past or current medical problems or findings from physical examination or laboratory testing that are not listed above which, in the opinion of the investigator, may pose additional risks from participation
MT2021-29: Evaluation of intravenous laronidase pharmacokinetics before and after hematopoietic cell transplantation in patients with mucopolysaccharidosis type IH
In this study, the researchers are collecting blood samples to learn more about laronidase treatment in children that receive a hematopoietic cell transplantation. The laronidase dose regimens used after a hematopoietic cell transplantation may differ from those administered before. This study will establish the basis for determining if there is a need to adjust laronidase dosing regimens after receiving a hematopoietic cell transplantation.
• between 0 to 3 years of age
• meet protocol specific eligibility criteria for allogeneic HCT for MPS IH
• planning to receive laronidase both pre and post-transplant in an inpatient setting as part of standard-of-care treatment. Virtually all patients with MPSIH being considered for transplantation at the University of Minnesota are already receiving enzyme infusions, and it is standard practice to continue to give enzyme infusions to 8 weeks post-transplant. Therefore, participation will not modify the treatment course
• patient's parent/ legal guardians are unable to provide informed consent.
COG AGCT1532 - A Randomized Phase 3 Trial of Accelerated versus Standard BEP Chemotherapy for Patients with Intermediate and Poor-risk Metastatic Germ Cell Tumors (P3BEP)
This trial is an open label, randomized, stratified 2-arm Australian-led multicenter phase 3 clinical trial undertaken in two stages. Participants (age >= 11 years and <= 45 years) with intermediate and poor-risk metastatic germ cell tumors will be randomized into either a “standard BEP” group or “accelerated BEP” group. Participants will be assigned to the two treatment arms in a 1:1 ratio and evaluated weekly, and then for 5 years after completing the study to assess the long-term effects of the chemotherapy. Bleomycin, Etoposide, Cisplatin (BEP) administered 3-weekly x 4 remains standard 1st line chemotherapy for intermediate- and poor-risk metastatic germ cell tumours (GCTs). BEP is accelerated by cycling Cisplatin and etoposide 2-weekly instead of 3-weekly. The aim of this study is to determine if accelerated BEP is superior to standard BEP as first-line chemotherapy for intermediate and poor risk metastatic GCTs.
• between 11 years and 45 years old
• confirmed germ cell tumour (non-seminoma or seminoma) OR Exceptionally raised tumour markers (AFP equal or greater than 1000ng/mL and/or HCG equal or greater than 5000 IU/L)
• primary arising in testis, ovary, retro-peritoneum, or mediastinum
• metastatic disease or non-testicular primary
• see link to clinicaltrials.gov for completed Inclusion/Exclusion criteria
• other primary malignancy (EXCEPT adequately treated non-melanomatous carcinoma of the skin, germ cell tumour, or other malignancy treated at least 5 years previously with no evidence of recurrence)
• significant cardiac disease resulting in inability to tolerate IV fluid hydration for cisplatin
• peripheral neuropathy equal or greater than grade 2 or clinically significant sensorineural hearing loss or tinnitus
MT2015-25: Tandem Myeloablative Consolidation Therapy and Autologous Stem Cell Rescue for High-Risk Neuroblastoma
The primary purpose of this study is to gain information, especially disease free outcomes, using the tandem approach as compared to the historical information of using a single transplant. The data will be analyzed for transplant “milestones” such as time to blood count recovery and how patients are doing at 3 months and 1 year after the treatment. Participation in this study will not alter treatment or medical care. All information for this study will be collected from medical records.
• less than 30 years old when diagnosis of neuroblastoma is made
• no uncontrolled infection
• recovered from acute toxicities of last cycle of induction chemotherapy
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
A non-randomized prospective clinical trial comparing the non-inferiority of salpingectomy to salpingo-oophorectomy to reduce the risk of ovarian cancer among BRCA1 carriers (SOROCk)
The purpose of the study is to compare two surgical procedures and their ability to decrease the risk of developing ovarian cancer for pre-menopausal women with BRCA1 mutations.
• 35 to 50 years old
• women with a BRCA1 mutation
• undergoing risk-reducing salpingo-oophorectomy or who have declined or elected to defer BSO
• may be premenopausal or menopausal
• history of any prior cancer who have received chemotherapy within the past 30 days or radiotherapy to abdomen or pelvis at any prior time
• women with abnormal screening tests (TVUS, CA-125) suspicious for gross cancer within the past 180 days
• additional criteria apply (study staff will review)
Colorectal Cancer Metastatic dMMR/MSI-H Immuno-Therapy (COMMIT) Study: A Randomized Phase III Study of mFOLFOX6/Bevacizumab/Atezolizumab Combination Versus Single Agent Atezolizumab in the First-Line Treatment of Patients With Deficient DNA Mismatch Repair (dMMR)/Microsatellite Instability-High (MSI-H) Metastatic Colorectal Cancer
We are studying how well combination chemotherapy, bevacizumab, and/or atezolizumab work in treating people with deficient deoxyribonucleic acid (DNA) mismatch repair colorectal cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Chemotherapy drugs, such as fluorouracil, oxaliplatin, and leucovorin calcium, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab may stop or slow colorectal cancer by blocking the growth of new blood vessels necessary for tumor growth. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving combination chemotherapy, bevacizumab, and atezolizumab may work better in treating patients with colorectal cancer.
• diagnosis of metastatic adenocarcinoma of colon or rectum without previous chemotherapy or any other systemic therapy for metastatic colorectal cancer except for one cycle of FOLFOX or capecitabine and oxaliplatin (CAPOX), with or without bevacizumab
• tumor determined to be mismatch-repair deficient (dMMR)
• able to walk & do selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• additional criteria apply (study staff will review)
• women who are pregnant or breast feeding
• treatment with oxaliplatin chemotherapy within 6 months prior to randomization
• history of significant liver, heart, lung, or autoimmune disease etc. (study staff will review)
A Randomized Phase III Study of Immune Checkpoint Inhibition with Chemotherapy in Treatment-Naive Metastatic Anal Cancer Patients
We are looking at the addition of nivolumab to chemotherapy compared to usual treatment (chemotherapy alone) for the treatment of anal cancer that has spread to other places in the body. Immunotherapy, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells. Giving nivolumab with chemotherapy may help doctors find out if the treatment is better or the same as the usual approach.
• inoperable, recurrent, or metastatic anal cancer
• restricted from strenuous activity but can walk and are able to carry out work of a light or sedentary nature
• requirements for lab results at a defined level (study staff will review)
• history of significant heart disease
• women who are pregnant or breastfeeding
• previous use of systemic chemotherapy or other investigational drugs
• prior immunotherapy
• active autoimmune disease or history of autoimmune disease
• other primary cancer within the last 3 years
• intermittent peripheral neuropathy
• additional exclusion criteria that study study will review
The CompassHER2 Trials (Comprehensive Use of Pathologic Response Assessment to Optimize Therapy in HER2-Positive Breast Cancer) CompassHER2 Residual Disease (RD), a Double-Blinded, Phase III Randomized Trial of T-DM1 Compared With T-DM1 and Tucatinib
We are studying how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from coming back (relapsing) in patients with high risk, HER2 positive breast cancer. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
• diagnosis of HER2-positive breast cancer
• received neoadjuvant (before surgery) chemotherapy
• had surgery that removed all disease in the breast and lymph nodes
• restricted from strenuous activity but can walk and do work of a light or sedentary nature, e.g., light house work, office work
• additional criteria apply (study staff will review)
• women who are pregnant or breastfeeding
• history of prior invasive breast cancer within past 3 years
• peripheral neuropathy that is more than intermittent & mild
• see link to clinicaltrials.gov for additional exclusion criteria
HM2017-24 : Phase I/II Study of Nivolumab in Combination with Ruxolitinib in Relapsed or Refractory Classical Hodgkin Lymphoma: BTCRC-HEM-027
Participants who take part in this study will receive a study drug called ruxolitinib with a standard drug called nivolumab. The study is being done to measure the percentage of tumor (lymphoma) that shrinks after receiving ruxolitinib in combination with nivolumab. This study will also measure the length of time the lymphoma is inactive and how safe the combination is to administer to participants. Ruxolitinib is a pill that is taken twice every day. Nivolumab is given as an infusion in the clinic once every 4 weeks.
• age 18 or older
• able to walk and do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• confirmed diagnosis of classical Hodgkin lymphoma that has reoccurred or not responded to treatment
• women and men who are of child bearing age must use required birth control
• there are additional criteria for prior treatment and laboratory results (study staff will review)
• inability to swallow oral medication or any condition that affects absorption of oral medications
• women who are pregnant or breast feeding
• additional criteria about current medical history (study staff will review)
Developing Evidence-Based Criteria for Initiating Treatment for Neurofibromatosis Type 1 Associated Optic Pathway Glioma
To determine the prognostic factors for visual outcome for newly diagnosed NF1-OPGs. Hypothesis: Patients (<18 years of age) with tumors involving the optic tracts and/or radiations will demonstrate worse visual outcomes compared to those without optic tract involvement.
• less than 18 years old
• EITHER the clinical diagnosis of NF1 OR have a constitutional NF1 mutation
• newly diagnosed Optic Pathway Glioma (OPG) (confirmed by MRI within 1 month of enrollment)
• additional inclusion and exclusion criteria (study staff will review)
• OPGs involving only the optic radiations
• prior therapy for an OPG (e.g. surgery [including biopsy], radiotherapy, chemotherapy, etc.)
• prior therapy for another (non-OPG) tumor
• history of hydrocephalus requiring surgical intervention
COG AGCT1531 - A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors
This partially randomized phase III trial studies how well active surveillance, bleomycin, carboplatin, etoposide, or cisplatin work in treating pediatric and adult patients with germ cell tumors. Active surveillance may help doctors to monitor subjects with low risk germ cell tumors after their tumor is removed. Drugs used in chemotherapy, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
• newly diagnosed with a Stage I germ cell tumor or metastatic germ cell tumor
• see link to clinicaltrials.gov for detailed inclusion criteria
• patients must have had no prior systemic therapy for the current cancer diagnosis
• patients must have had no prior radiation therapy (exception of CNS irradiation of brain metastases for standard risk 1 patients)
• female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs
• lactating females who plan to breastfeed their infants
• there are additional exclusion criteria (study staff will review)
Testing Effective Methods to Recruit Sexual and Gender Minority Cancer Patients for Cancer Studies: Aim 1 SGM Interviews
This is a study about how to recruit sexual and gender diverse people into cancer research studies. You will be asked to participate in a secure Zoom interview; if you do not have access to Zoom an interview may occur over the phone. The interview will take about 60-90 minutes, and we will ask questions about your experience with participating in cancer research studies and your experience during treatment.
• people who identify as LGBT
• at least 18 years of age
• currently living in the US
• diagnosed with and treated for cancer.
• speak English
• people who have been diagnosed with cancer but haven't been treated
Surgical Window of Opportunity Study of Megestrol Acetate Compared with Megestrol Acetate and Metformin for Endometrial Intraepithelial Neoplasia
The purpose of this study is to compare the effectiveness of megestrol alone, or combined with metformin, on the growth of Endometrial Intraepithelial Neoplasia (EIN). Participants will receive medication directed against EIN prior to the planned procedure (hysterectomy or progestin IUD placement). Women will receive either megestrol acetate pills by mouth twice a day for 3 to 5 weeks, or megestrol acetate and metformin pills twice a day by mouth for 3 to 5 weeks.
• endometrial intraepithelial neoplasia (EIN) on an endometrial biopsy or dilation and curettage specimen
• willing to have surgery (hysterectomy) or non-surgical treatment with a progestin IUD
• if diabetic, blood glucose must be appropriately controlled as evidenced by a hemoglobin A1c of < 8.0 in the last three months prior to enrollment
• women of child-bearing potential must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
• Current hormonal contraceptives or post-menopausal hormone replacement therapy, and uses of progestins (including progestin containing intrauterine device (there are exceptions, study staff will review)
• current use of metformin therapy. If previously used, it must be discontinued at least a year ago
• women who are pregnant or breast feeding
• history of pulmonary embolism, thrombotic stroke, arterial thrombosis or deep vein thrombosis
• see link to clinicaltrials.gov for additional inclusion and exclusion criteria
Save the Bottoms!!!: Assessing the Gay Male Experience with Anal Cancer Prevention Strategies
The purpose of this study is to describe current knowledge and opinions about anal cancer screening among men who have sex with men (MSM), as well as their experience receiving guideline-compliant care aimed at anal cancer risk reduction using a large-scale survey disseminated via social media.
• 18 years of age or older
• AMAB (Assigned Male at Birth)
• Current resident of the U.S.
• Engage in receptive anal intercourse with male partners
• Fluent in English or Spanish
Observational Study of Pediatric Rheumatic Diseases: The CARRA Registry
The primary objective for this observational study is to collect general and medical data from children, adolescents, and young adults who had pediatric onset rheumatic disease. This data will be used to evaluate the long-term safety and efficacy of therapeutic agents used to treat these diseases. This information will allow investigators to accurately report and follow changes in current medication use patterns and compare these to proposed standards and current treatment recommendations. The use of a single registry will allow for more analysis of the different therapeutic agents by allowing them to be compared to each other.
• diagnosed with rheumatic disease prior to age 16 years for juvenile idiopathic arthritis (JIA)
• onset prior to age 19 years for all other rheumatic diseases
• younger than 21 years
DORA Trial: Phase III Trial of Docetaxel vs. Docetaxel and Radium-223 for Metastatic Castration-Resistant Prostate Cancer (mCRPC)
The purpose of this research is to compare any good and bad effects of using radium-223 along with docetaxel chemotherapy (at a lower dose) treatment versus using docetaxel alone (at the usual dose). The addition of radium-223 to docetaxel could be a better cancer treatment than just docetaxel alone, but it could also cause additional side effects. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach.
• at least 18 years old
• diagnosis of prostate cancer
• confirmed progressive Metastatic Castration-Resistant Prostate Cancer (mCRPC)
• two or more bone lesions
• serum testosterone less than 50 ng/dL
• able to walk, carry out light work, and care for self independently
• received four or more systemic anticancer regimens for mCRPC (study staff will review) -received any prostate cancer chemotherapy for mCRPC
• any other serious illness or medical condition
PEPN2111 - A Phase 1/2 Trial of CBL0137 (NSC# 825802, IND# 155843) in Patients with Relapsed or Refractory Solid Tumors including CNS Tumors and Lymphoma
A Phase I/II trial of single agent intravenous CBL0137 in pediatric patients (≥ 12 months and ≤ 30 years) with relapsed/refractory solid tumors, including CNS tumors and lymphoma.
• 12 months to 30 years old
• patients with relapsed or refractory solid tumors or lymphoma, including patients with CNS tumors or known CNS metastases, or patients with progressive or recurrent DIPG (diagnosed by biopsy or imaging characteristics) and other H3 K27M-mutant diffuse midline gliomas previously treated with radiation therapy, or patients with relapsed or refractory osteosarcoma
• 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
• patients have consented to receive a central venous catheter prior to the administration of CBL0137
• see link to clnicaltrials.gov for complete inclusion and exclusion criteria
• pregnant or breast-feeding women
• patients who have an uncontrolled infection
• patients who have received a prior solid organ transplantation
AOST2031: A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma
This phase III trial compares the effect of open thoracic surgery (thoracotomy) to thoracoscopic surgery (video-assisted thoracoscopic surgery or VATS) in treating patients with osteosarcoma that has spread to the lung (pulmonary metastases). Open thoracic surgery is a type of surgery done through a single larger incision (like a large cut) that goes between the ribs, opens up the chest, and removes the cancer. Thoracoscopy is a type of chest surgery where the doctor makes several small incisions and uses a small camera to help with removing the cancer. This trial is being done evaluate the two different surgery methods for patients with osteosarcoma that has spread to the lung to find out which is better.
• 50 years of age or younger
• have 4 or less nodules in the lung due to metastases or suspected metastases
• diagnosis of osteosarcoma
• contact study team for more detailed criteria
• pleural or mediastinal based metastatic lesions, or with pleural effusion
• large, or central tumors that require a lobectomy or pneumonectomy
Can spectral power and coherence reflect the integrity of the efferent cerebellar cortical pathway in cerebellar mutism syndrome?
This study will be measuring brain activity using EEG and assessing motor skills and speech in children following cancerous brain tumor resection. No direct cancer treatments or objectives are being targeted.
• Cerebellar Mutism Syndrome (CMS) & Comparison (without CMS) Groups: ages 10 years 0 months to 25 years 11 months of age & fluent in English (parents/guardian do not need to be fluent in English)
• For those with Cerebellar Mutism Syndrome (CMS): history of resection of posterior fossa tumor at least 2 years before starting the study and at least 3 months post chemotherapy and radiation treatment
• Comparison group without CMS: any developmental conditions including ADD/ADHD, learning disabilities, speech/language delay or disorder, motor delay/disorder, cognitive delay and/or diagnosis of autism spectrum disorder
• any genetic condition
• any neurologic condition including history of stroke, seizure disorder, or brain injury
• history of brain tumor or other cancer diagnosis
• CMS Group: any developmental conditions including ADD/ADHD, learning disabilities, speech/language delay or disorder, motor delay/disorder, cognitive delay and/or diagnosis of autism spectrum disorder prior to brain tumor diagnosis
• any genetic condition prior to brain tumor diagnosis
• any neurologic condition including history of stroke, seizure disorder, or brain injury disorder prior to brain tumor diagnosis
A Randomized Phase III, Two-Arm Trial of Paclitaxel/Carboplatin/Maintenance Letrozole Versus Letrozole Monotherapy in Patients with Stage II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or Peritoneum
We are looking at how well letrozole with or without paclitaxel and carboplatin works in treating patients with stage II-IV low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum. Letrozole is an enzyme inhibitor that lowers the amount of estrogen made by the body and may stop the growth of tumor cells that need estrogen to grow. We will compare the effectiveness of the two different treatments.
• newly diagnosed, stage II-IV low-grade serous ovarian cancer fallopian tube or primary peritoneal cancers
• surgery for maximal cytoreduction completed within 8 weeks of randomization
• bilateral salpingo-oophorectomy completed
• able to take oral medications
• prior neoadjuvant chemotherapy, endocrine therapy or radiotherapy for the treatment of this disease
• severe cardiac disease
Randomized Phase III Study of Combination AZD9291 (osimertinib) and Bevacizumab versus AZD9291 (osimertinib) Alone as First-Line Treatment for Patients with Metastatic EGFR-Mutant Non-Small Cell Lung Cancer (NSCLC)
This trial compares the effect of bevacizumab and osimertinib combination vs. osimertinib alone for the treatment of non-small cell lung cancer that has spread outside of the lungs and has a change (mutation) in a gene called EGFR. Sometimes, mutations in this gene cause EGFR proteins to be made in higher than normal amounts on some types of cancer cells. This causes cancer cells to divide more rapidly.
• confirmed diagnosis of non-squamous, non-small cell lung cancer (NSCLC)
• have advanced disease, defined as - either stage IV disease, stage IIIB disease not amenable to definitive therapy, or recurrent disease
• no prior systemic treatment for metastatic disease
• able to walk and do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• additional inclusion criteria (study staff will review)
MT2019-38: Development and Psychometric Testing of a Pediatric Chronic Graft-Versus-Host Disease (GVHD) Symptom Scale (PCSS)
The purpose of this study is to develop a questionnaire specifically designed for children and adolescents, which will help health care providers to better measure how bothersome symptoms of cGVHD are for children and adolescents living with cGVHD. Another purpose of this study is to design a caregiver companion questionnaire, to allow caregivers to measure how bothersome the symptoms of cGVHD are for their child/adolescent.
• children aged 5 to 17 years old, who have undergone prior allogeneic stem cell transplant
• clinical diagnosis of Graft vs Host Disease (cGVHD)
• currently receiving systemic treatment for cGVHD (including phototherapies), or has had systemic therapy for cGVHD tapered to discontinuation within the past 12 months -eligible caregiver proxy who is willing to participate in the study
• see link to clinicaltrials.gov for complete criteria
• participant's cognitive ability would compromise their ability to participate in study related procedures
• study staff will review
NRG-BN011: A Phase III Trial of Lomustine-Temozolomide Combination Therapy Versus Standard Temozolomide in Patients with Methylated MGMT Promoter Glioblastoma
We are looking at adding lomustine to temozolomide and radiation therapy when compared to temozolomide and radiation therapy alone (usual care). We will compare the effect (shrinking or stabilizing) and side effects when treating newly diagnosed MGMT methylated glioblastoma. Each of the drugs and radiation work in a different way to stop the growth of tumor cells.
• 18 to 70 years old
• no known IDH mutation
• must consent and have tumor submitted within 30 days of surgery
• adequate hematologic, kidney, and liver function (study staff will review)
• previous treatment of the brain tumor
• prior cancer (except non-melanomatous skin cancer, cervical cancer in situ and melanoma in situ) unless disease free for a minimum of 2 years
• women who are pregnant or breast feeding
Disparities in REsults of Immune Checkpoint Inhibitor Treatment (DiRECT): A Prospective Cohort Study of Cancer Survivors Treated With Anti-PD-1/Anti-PD-L1 Immunotherapy in a Community Oncology Setting (DiRECT)
This study compares treatment outcomes between patients of African American/Black (AA) ancestry and European American/White (EA) ancestry currently receiving immune checkpoint inhibitor treatment. Collecting samples of blood and saliva and health and treatment information from racially diverse patients receiving immune checkpoint inhibitor treatment over time may help doctors better understand health care disparities among all cancer patients.
• self-identify as African/African American/black (AA), or European American/ Caucasian/white (EA), or Hispanic/Latino ethnicity in combination with an AA or EA racial identity
• current diagnosis of invasive cancer at stage I-IV
• scheduled to receive anti-PD-1/-L1 ICI-containing therapy as standard of care treatment alone or in combination with co-treatments
• identify as Asian, Pacific Islander, or American Indian/Alaskan Native
• diagnosed with melanoma (because melanoma is very rare in AAs)
• received prior immunotherapy for cancer,
Treatment of Refractory Nausea
We are studying different drugs for the treatment of nausea and vomiting that is caused by chemotherapy treatment of people who have breast cancer.
• diagnosis of breast cancer and not yet started chemotherapy
• scheduled to receive a single-day chemotherapy regimen that contains doxorubicin and/or cyclophosphamide and/or carboplatin
• scheduled to receive an antiemetic regimen that does not contain Akynzeo
• clinical evidence of current or impending bowel obstruction
• history of central nervous system disease (e.g., brain metastases or a seizure disorder)
• uncontrolled diabetes mellitus or uncontrolled hyperglycemia
• long term treatment (> 5 days within the past 30 days) with an antipsychotic agent such as risperidone, quetiapine, clozapine, a phenothiazine, or a butyrophenone within 30 days before enrollment or plans for such treatment during the study period
• taking benzodiazepines regularly (> 5 days within the past 30 days); (PRN) use (=< 5 days) for the short-term relief of the symptoms of anxiety, anxiety associated with depressive symptoms
Pragmatica-Lung: A Prospective Randomized Study of Ramucirumab (LY3009806; NSC 749128) Plus Pembrolizumab (MK-3475; NSC 776864) Versus Standard of Care for Participants Previously Treated With Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer
We are comparing the effectiveness of the combination of ramucirumab and pembrolizumab compared to the usual chemotherapy for the treatment of non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). The drugs work in different ways to stop the growth of tumor cells. We will compare how well the treatment regimens work and the side effects that occur.
• at least 18 years old
• confirmed non-small cell lung cancer (NSCLC) which is stage IV (metastatic) or has recurred
• must have received at least one previous treatment of immune therapy
• must have received platinum-based chemotherapy
• able to care for self with occasional assistance
• may not have received more than one treatment with immunotherapy for stage IV or recurrent disease
• may not receive receive another investigational drug during study participation
Internet-delivered Management of Pain Among Cancer Treatment Survivors (IMPACTS)
We are studying an internet-based pain coping skills program with pain education for cancer survivors who have persistent pain. Pain severity and interference will be compared to people who receive only pain education. The pain coping program has 8 sessions that are completed in the first 10 weeks of starting the study. The group that receives only pain education will receive access to the program after 6 months. Everyone is followed for 9 months
• diagnosis of invasive cancer that has been treated with either single therapy or any combination of surgery, radiation, chemotherapy/drug therapy
• may be either off all treatment OR actively receiving anticancer therapy in an adjuvant (after surgery) setting, maintenance setting, or for active cancer that is felt to be stable and/or controlled and not rapidly progressive
• less than/equal to 5 years since the completion of their anticancer therapy
• experiencing continued pain
• cancer history of only superficial skin cancers or in situ malignancy
• only preexisting pain conditions unrelated to cancer or cancer treatment (e.g., migraine or tension headache, arthritis, back disorders, bursitis/tendonitis, injuries, fibromyalgia)
• known or suspected diagnosable substance use disorder or opioid overuse disorder
• enrolled in hospice care or end-of-life palliative care