UMN - StudyFinder

SpHincterotomy for Acute Recurrent Pancreatitis (SHARP) Trial (SHARP)

Description:

This is a sham-controlled, single blinded with a blinded outcome assessment, multi-center, randomized clinical trial of endoscopic retrograde cholangiopancreatography (ERCP) with minor papilla endoscopic sphincterotomy (miES) for the treatment of recurrent acute pancreatitis (RAP) with pancreas divisum. ERCP with miES is often offered in clinical practice to patients with RAP, pancreas divisum, and no other clear risk factors for their acute pancreatitis episodes. We hypothesize that obstruction at the level of the minor papilla is one cause of RAP in pancreas divisum; miES will relieve the obstruction, thereby reducing the risk of a recurrent attack(s) of acute pancreatitis.

Principal Investigator: Martin Freeman

Sex: All

Age: 18 Years to old

Phase: N/A

System ID: STUDY00004817

IRB Number: STUDY00004817

Show full eligibility criteria

Interventions: Procedure: ERCP with miES, Procedure: EUS

Conditions: Pancreatitis, Pancreas Divisum, Pancreatitis, Acute, Pancreatitis Idiopathic, Pancreas Inflamed

Keywords: Clinics and Surgery Center (CSC)

I'm interested

Share via email

See this study on ClinicalTrials.gov

COG APEC14B1 The Project: Every Child Protocol: A Registry, Eligibility Screening, Biology and Outcome Study Additional Title: EVERYCHILD (APEC14B1) PCR - COG Foundation

Description:

This research trial studies the Project: Every Child for younger patients with cancer. Gathering health information over time from younger patients with cancer may help doctors find better methods of treatment and on-going care.

Principal Investigator: Emily Greengard

Sex: All

Age: to 25 Years old

System ID: 1603M85344

IRB Number: 1603M85344

Show full eligibility criteria

Inclusion Criteria:

Enrollment must occur within 6 months of initial disease presentation OR within 6 months of refractory disease, disease progression, disease recurrence, second or secondary malignancy, or post-mortem Patients previously enrolled on ACCRN07 are eligible to enroll on Tracking Outcome, Registry and Future Contact components of APEC14B1 any time after they reach age of majority Patients with a known or suspected neoplasm that occurs in the pediatric, adolescent or young adult populations are eligible for enrollment as follows: All cancer cases with an International Classification of Diseases for Oncology (ICD-O) histologic behavior code of two "2" (carcinoma in situ) or three "3" (malignant) All neoplastic lesions of the central nervous system regardless of behavior, i.e., benign, borderline or malignant The following other benign/borderline conditions: Mesoblastic nephroma Teratomas (mature and immature types) Myeloproliferative diseases including transient myeloproliferative disease Langerhans cell histiocytosis Lymphoproliferative diseases Desmoid tumors Gonadal stromal cell tumors Subjects must be =< 25 years of age at time of original diagnosis, except for patients who are being screened specifically for eligibility onto a COG (or COG participating National Clinical Trials Network [NCTN]) therapeutic study, for which there is a higher upper age limit All patients or their parents or legally authorized representatives must sign a written informed consent and agree to participate in at least one component of the study; parents will be asked to sign a separate consent for their own biospecimen submission If patients or their parents or legally authorized representatives have not signed the Part A subject consent form at the time of a diagnostic bone marrow procedure, it is recommended that they initially provide consent for drawing extra bone marrow using the Consent for Collection of Additional Bone Marrow; consent using the Part A subject consent form must be provided prior to any other procedures for eligibility screening or banking under APEC14B1

Interventions: Other: Cytology Specimen Collection Procedure, Other: Medical Chart Review

Conditions: Carcinoma In Situ, Central Nervous System Neoplasm, Childhood Immature Teratoma, Childhood Langerhans Cell Histiocytosis, Childhood Mature Teratoma, Congenital Mesoblastic Nephroma, Desmoid Fibromatosis, Lymphoproliferative Disorder, Malignant Solid Neoplasm, Myeloproliferative Neoplasm, Stromal Neoplasm

I'm interested

Share via email

See this study on ClinicalTrials.gov

MT2017-45 :Chimeric Antigen Receptor (CAR)-T Cell Therapy for Patients with Hematologic Malignancies

Description:

This is a phase II study of FDA-approved CAR-T products for patients with hematologic malignancies. The study provides criteria for consistent treatment and management according to FDA labelling of CAR-T products and does not contain experimental components. Patients will be assigned to Arms A B and C based on age, CAR-T product and diagnosis. Overall remission rate, safety events and other endpoints will be calculated for Arms A B and C separately.

Principal Investigator: Veronika Bachanova, MD

Sex: All

System ID: STUDY00004096

IRB Number: STUDY00004096

Show full eligibility criteria

ARM A (Kymriah) and Arm G (Tecartus) :Refractory/relapsed B-cell acute lymphoblastic leukemia expressing CD19

Inclusion Criteria:

Age and Disease Status Must be age 0-25 years (for Arm A Kymriah) or >18 years (Arm G Tecartus) Disease status: Relapsed and refractory pediatric B-cell ALL defined by one of these: Primary induction failure with no complete remission after ≥2 cycles of induction chemotherapy, or Patients with persistent minimal residual disease (MRD >0.01% by flow cytometry or persistent by cytogenetic or molecular assays) after ≥2 cycles of consolidation chemotherapy, or Patients in 2nd or greater relapse of B-ALL or Patients with persistent CNS leukemia, or Down Syndrome or other congenital diseases assuming that they fit the criteria for second or greater relapse or refractory leukemia, or Patients with Ph+ ALL are eligible if theywho have failed or are intolerant to two lines of TKI assuming they fit the criteria for second or greater relapse or are considered refractory. Performance Status * Arm A: Karnofsky (age ≥16 years) or Lansky (age < 16 years) performance status ≥ 50% at screening; Arm G: ECOG 0, 1 or 2 Organ Function Renal function defined as: A serum creatinine of ≤1.5 x ULN OR eGFR ≥ 50 mL/min/1.73 m2 Liver function defined as: ** ALT ≤ 5 times the ULN for age (unless due to disease) ** Bilirubin ≤ 2.0 mg/dl with the exception of patients with Gilbert syndrome; may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygenation SpO2 > 91% on room air Hemodynamically stable and LVEF ≥ 45% confirmed by echocardiogram or MUGA Other Inclusion Criteria Life expectancy ≥12 weeks Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment. Written voluntary consent (adults) or parental/guardian consent (minors or adults with diminished capacity) prior to the performance of any research related tests or procedures.

Exclusion Criteria:

Pregnant or breastfeeding - Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy. Patients with Burkitt's lymphoma/leukemia (i.e. patients with mature B-cell ALL, leukemia with B-cell [sIg positive and kappa or lambda restricted positivity] ALL, with FAB L3 morphology and /or a MYC translocation) CNS 2A CAR-T is not indicated for the treatment of patients with primary central nervous system lymphoma. Presence of Grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD). All GVHD medication must be stopped 2 weeks prior to apheresis. Uncontrolled active hepatitis B or hepatitis C Active HIV infection Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g. blood culture positive ≤ 72 hours prior to infusion) Unstable angina and/or myocardial infarction within 1 month prior to CAR-T infusion Investigational medicinal product within the last 7 days prior to apheresis or CAR-T infusion Intolerance to the excipients of the CAR-T cell product Any immunosuppressive medication must be stopped ≥ 2 weeks prior to enrollment. Patient has taken one of the prohibited concomitant medications within the timeframe outlined in section 6.1 ARM B: Yescarta for Relapsed or Refractory diffuse large B cell lymphoma

Inclusion Criteria:

Age and Disease Status Adult patients (age ≥ 18 years)Patients must be ≥18 years of age One of the following histologies and expression of CD19 by tumor cells: ** diffuse large B-cell lymphoma (DLBCL) not otherwise specified, or ** primary mediastinal large B-cell lymphoma, or ** high grade B-cell lymphoma, or ** DLBCL arising from follicular lymphoma Disease status: ** Chemotherapy refractory disease after ≥2 lines of chemotherapy, or ** Relapsed with no remission after ≥1 lines of salvage chemotherapy, or ** Relapsed following autologous HCT (and failed at least 2 prior lines of therapy including high dose chemotherapy). If salvage therapy is given post autoHCT, the subject must have no response or relapse after the last line of therapy Measurable disease at time of apheresis: Nodal lesions or extranodal lesion ECOG performance status 0-2 ALC >/=100/uL at screening (prior to apheresis) Renal function defined as: ** A serum creatinine of ≤1.5 x ULN OR ** eGFR ≥ 50 mL/min/1.73 m2 Liver function defined as: ALT ≤ 5 times the ULN for age (unless due to disease) Bilirubin ≤ 2.0 mg/dl with the exception of patients with Gilbert syndrome; may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygenation SpO2 > 91% on room air Hemodynamically stable and LVEF ≥ 45% confirmed by echocardiogram or MUGA Adequate bone marrow reserve (unless marrow infiltrated by disease) defined as : Absolute neutrophil count (ANC) > 1.000/mm3 (only for NHL) Platelets ≥ 50.000/mm3 (transfusion support can be provided) Hemoglobin >8.0 mg/dl (transfusion support can be provided) Life expectancy ≥12 weeks Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment. Written voluntary consent (adults) or parental/guardian consent (minors or adults with diminished capacity) prior to the performance of any research related tests or procedures.

Exclusion Criteria:

Pregnant or breastfeeding - Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy. Active CNS involvement by malignancy (no evidence of disease in CSF by flow cytometry) CAR-T is not indicated for the treatment of patients with primary central nervous system lymphoma. Presence of Grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD). All GVHD medication must be stopped 2 weeks prior to apheresis. Uncontrolled active hepatitis B or hepatitis C Active HIV infection (controlled HIV is permissible) Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g. blood culture positive ≤ 72 hours prior to infusion) Unstable angina and/or myocardial infarction within 1 month prior to CAR-T infusion Investigational medicinal product within the last 7 days prior to apheresis or CAR-T infusion Intolerance to the excipients of the CAR-T cell product Any immunosuppressive medication must be stopped ≥ 2 weeks prior to apheresis. Patient has taken one of the prohibited concomitant medications within the timeframe. ARM C: Kymriah for rRelapsed or rRefractory diffuse large B cell lymphoma

Inclusion Criteria:

Age and Disease Status Adult patients (age ≥ 18 years) with relapsed or refractory (r/r) large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma. Disease status: after two or more lines of systemic therapy or relapse after autologous HCT Performance Status ECOG performance status 0-2 ALC >/=100/uL at screening (prior to apheresis) Organ Function Renal function defined as: A serum creatinine of ≤1.5 x ULN OR eGFR ≥ 50 mL/min/1.73 m^2 Liver function defined as: ALT ≤ 5 times the ULN for age (unless due to disease) Bilirubin ≤ 2.0 mg/dl with the exception of patients with Gilbert syndrome; may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygenation SpO2 > 91% on room air Hemodynamically stable and LVEF ≥ 45% confirmed by echocardiogram or MUGA Adequate bone marrow reserve (unless marrow infiltrated by disease) defined as : Absolute neutrophil count (ANC) > 1.000/mm3 (only for NHL) Platelets ≥ 50.000/mm3 (transfusion support can be provided) Hemoglobin >8.0 mg/dl (transfusion support can be provided) Other Inclusion Criteria Life expectancy ≥12 weeks Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment. Written voluntary consent (adults) or parental/guardian consent (minors or adults with diminished capacity) prior to the performance of any research related tests or procedures.

Exclusion Criteria:

Pregnant or breastfeeding - Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy. Active CNS involvement by malignancy (no evidence of disease in CSF by flow cytometry) CAR-T is not indicated for the treatment of patients with primary central nervous system lymphoma. Presence of Grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD). All GVHD medication must be stopped 2 weeks prior to apheresis. Uncontrolled active hepatitis B or hepatitis C Active or inactive HIV infection Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g. blood culture positive ≤ 72 hours prior to infusion) Unstable angina and/or myocardial infarction within 1 month prior to CAR-T infusion Investigational medicinal product within the last 7 days prior to apheresis or CAR-T infusion Intolerance to the excipients of the CAR-T cell product Any immunosuppressive medication must be stopped ≥ 2 weeks prior to apheresis. Patient has taken one of the prohibited concomitant medications within the timeframe ARM D: Tecartus (Brexucabtagene Autoleucel) for relapsed or refractory mantle cell lymphoma

Inclusion Criteria:

Age and Disease Status * with relapsed or refractory (r/r) mantle cell lymphoma, including prior anthracycline or Bendamustine containing therapy prior Rituximab or other CD20 directed antibody (or inability to treat with CD20 MoAb) not a candidate or relapse after autologous HCT active disease at enrollment Performance Status *ECOG performance status 0-1 Organ Function Renal function defined as: A serum creatinine of ≤1.5 x ULN OR eGFR ≥ 50 mL/min/1.73 m2 Liver function defined as: ALT ≤ 5 times the ULN for age (unless due to disease) Bilirubin ≤ 2.0 mg/dl with the exception of patients with Gilbert syndrome; may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygenation SpO2 > 91% on room air Hemodynamically stable and LVEF ≥ 45% confirmed by echocardiogram or MUGA Adequate bone marrow reserve (unless marrow infiltrated by disease) defined as: Absolute neutrophil count (ANC) > 1,000/mm^3 (only for NHL) Platelets ≥ 50,000/mm^3 (transfusion support can be provided) Hemoglobin >8.0 mg/dl (transfusion support can be provided) Other

Inclusion Criteria:

Life expectancy ≥12 weeks Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment. See section 4.5 for definitions of child bearing potential and section 4.6 for definitions of adequate birth control. Written voluntary consent (adults) or parental/guardian consent (minors or adults with diminished capacity) prior to the performance of any research related tests or procedures.

Exclusion Criteria:

Pregnant or breastfeeding - Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy. Active CNS involvement by malignancy (no evidence of disease in CSF by flow cytometry) CAR-T is not indicated for the treatment of patients with primary central nervous system lymphoma. Presence of Grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD). All GVHD medication must be stopped 2 weeks prior to apheresis. Uncontrolled active hepatitis B or hepatitis C Active HIV infection Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g. blood culture positive ≤ 72 hours prior to infusion) Unstable angina and/or myocardial infarction within 1 month prior to CAR-T infusion Investigational medicinal product within the last 7 days prior to apheresis or CAR-T infusion Intolerance to the excipients of the CAR-T cell product Any immunosuppressive medication must be stopped ≥ 2 weeks prior to apheresis (steroids must be stopped >72 hours prior to apheresis). Patient has taken one of the prohibited concomitant medications within the timeframe ARM E: Breyanzi "lisocabtagene maraleucel" for relapsed or refractory large B-cell lymphoma

Inclusion Criteria:

Age and Disease Status Adult patients (age ≥ 18 years) with relapsed or refractory disease after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, follicular lymphoma grade 3B Performance Status *ECOG performance status 0-2 Organ Function Renal function defined as: A serum creatinine of ≤1.5 x ULN OR eGFR ≥ 30 mL/min/1.73 m2 Liver function defined as: ALT ≤ 5 times the ULN for age (unless due to disease) Bilirubin ≤ 2.0 mg/dl with the exception of patients with Gilbert syndrome; may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygenation SpO2 > 91% on room air Hemodynamically stable and LVEF ≥ 40% confirmed by echocardiogram or MUGA Adequate bone marrow reserve (unless marrow infiltrated by disease) defined as: Absolute neutrophil count (ANC) > 1,000/mm^3 (only for NHL) Platelets ≥ 50,000/mm^3 (transfusion support can be provided) Hemoglobin >8.0 mg/dl (transfusion support can be provided) Other

Inclusion Criteria:

Life expectancy ≥12 weeks Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment. See section 4.5 for definitions of child bearing potential and section 4.6 for definitions of adequate birth control. Written voluntary consent (adults) or parental/guardian consent (minors or adults with diminished capacity) prior to the performance of any research related tests or procedures.

Exclusion Criteria:

Pregnant or breastfeeding - Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy. Active CNS involvement by malignancy (no evidence of disease in CSF by flow cytometry) CAR-T is not indicated for the treatment of patients with primary central nervous system lymphoma. Presence of Grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD). All GVHD medication must be stopped 2 weeks prior to apheresis. Uncontrolled active hepatitis B or hepatitis C Active HIV infection Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g. blood culture positive ≤ 72 hours prior to infusion) Unstable angina and/or myocardial infarction within 1 month prior to CAR-T infusion Investigational medicinal product within the last 7 days prior to apheresis or CAR-T infusion Intolerance to the excipients of the CAR-T cell product Any immunosuppressive medication must be stopped ≥ 2 weeks prior to apheresis (steroids must be stopped >72 hours prior to apheresis). Patient has taken one of the prohibited concomitant medications within the timeframe ARM F: Abecma "Idecabtagene Vicleucel" for relapsed or refractory multiple myeloma

Inclusion Criteria:

Age and Disease Status Adult patients (age ≥ 18 years) Relapsed (progression after prior partial or complete remission) or refractory multiple myeloma Evidence of active disease (medullary or extramedullary) Prior therapy (Failure or intolerance to) with an immunomodulatory agent, a proteasome inhibitor, and an antiCD38 monoclonal antibody Performance Status *ECOG performance status 0-1 Organ Function Renal function defined as: A serum creatinine of ≤2 x ULN OR eGFR ≥ 50 mL/min/1.73 m2 Liver function defined as: ALT ≤ 5 times the ULN for age (unless due to disease) Bilirubin ≤ 2.0 mg/dl with the exception of patients with Gilbert syndrome; may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygenation SpO2 > 91% on room air Hemodynamically stable and LVEF ≥ 45% confirmed by echocardiogram or MUGA Adequate bone marrow reserve (unless marrow infiltrated by disease) defined as: Absolute neutrophil count (ANC) > 1,000/mm^3 (only for NHL) Platelets ≥ 50,000/mm^3 (transfusion support can be provided) Hemoglobin >8.0 mg/dl (transfusion support can be provided) Other

Inclusion Criteria:

Life expectancy ≥12 weeks Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment. See section 4.5 for definitions of child bearing potential and section 4.6 for definitions of adequate birth control. Written voluntary consent (adults) or parental/guardian consent (minors or adults with diminished capacity) prior to the performance of any research related tests or procedures.

Exclusion Criteria:

Pregnant or breastfeeding - Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy. Active CNS involvement by malignancy (no evidence of disease in CSF by flow cytometry) CAR-T is not indicated for the treatment of patients with primary central nervous system lymphoma. Presence of Grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD). All GVHD medication must be stopped 2 weeks prior to apheresis. Uncontrolled active hepatitis B or hepatitis C Active HIV infection Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g. blood culture positive ≤ 72 hours prior to infusion) Unstable angina and/or myocardial infarction within 1 month prior to CAR-T infusion Investigational medicinal product within the last 7 days prior to apheresis or CAR-T infusion Intolerance to the excipients of the CAR-T cell product Any immunosuppressive medication must be stopped ≥ 2 weeks prior to apheresis (steroids must be stopped >72 hours prior to apheresis). Patient has taken one of the prohibited concomitant medications within the timeframe

Interventions: Drug: Abecma, Intravenous Suspension, Drug: Breyanzi Injectable Product, Drug: Cyclophosphamide 250 mg/m2, 3 days, Drug: Cyclophosphamide 500 mg/m2, 2 doses, Drug: Cyclophosphamide 500 mg/m2, 3 doses, Drug: Cyclophosphamide 900 mg/m2, 1 day, Drug: Fludarabine 25mg/m2 3 days, Drug: Fludarabine 30mg/m2 3 doses, Drug: Fludarabine 30mg/m2 4 doses, Drug: KYMRIAH, Drug: Tecartus, Drug: YESCARTA

Conditions: Acute Lymphoblastic Leukemia, Large B-cell Lymphoma

Keywords: Clinics and Surgery Center (CSC)

I'm interested

Share via email

See this study on ClinicalTrials.gov

A Phase 1/2 Study of the Oral RET Inhibitor LOXO-292 in Pediatric Patients with Advanced RET-Altered Solid or Primary Central Nervous System Tumors; Protocol Number: LOXO-RET-18036 (J2G-OX-JZJJ) (LIBRETTO-121)

Description:

This is an open-label, multi-center, Phase 1/2 study of oral LOXO-292 in pediatric patients with an activating RET alteration and an advanced solid or primary CNS tumor.

Principal Investigator: Emily Greengard

Sex: All

Age: 6 Months to 21 Years old

Phase: Phase 1/Phase 2

System ID: STUDY00008874

IRB Number: STUDY00008874

Show full eligibility criteria

Interventions: Drug: LOXO-292

Conditions: Medullary Thyroid Cancer, Infantile Myofibromatosis, Infantile Fibrosarcoma, Papillary Thyroid Cancer, Soft Tissue Sarcoma

Keywords: Infantile Myofibromatosis, Infantile Fibrosarcoma, Loxo, LOXO-292, KIF5B-RET, M918T, CCDC6-RET, RET-PTC1, NCOA4-RET, RET-PTC, RET-PTC3, RET-PTC4, PRKAR1A-RET, RET-PTC2, GOLGA5-RET, RET-PTC5, ERC1-RET, KTN1-RET, RET-PTC8, HOOK3-RET, PCM1-RET, TRIM24-RET, RET-PTC6, TRIM27-RET, TRIM33-RET, RET-PTC7, AKAP13-RET, FKBP15-RET, SPECC1L-RET, TBL1XR1-RET, BCR-RET, FGRF1OP-RET, RFG8-RET, RET-PTC9, ACBD5-RET, MYH13-RET, CUX1-RET, KIAA1468-RET, FRMD4A-RET, SQSTM1-RET, AFAP1L2-RET, PPFIBP2-RET, EML4-RET, PARD3-RET, G533C, C609F, C609G, C609R, C609S, C609Y, C611F, C611G, C611S, C611Y, C611W, C618F, C618R, C618S, C620F, C620R, C620S, C630R, C630Y, D631Y, C634F, C634G, C634R, C634S, C634W, C634Y, K666E, E768D, L790F, V804L, V804M, A883F, S891A, R912P, CLIP1-RET, Y806C, RET fusion, RET alteration, RET mutation, RET rearrangement, RET translocation, Neoplasms by Site, Neoplasms, Non-Small Cell Lung Cancer, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Cancer of Lung, Cancer of the Lung, Lung Cancer, Neoplasms, Lung, Neoplasms, Pulmonary, Pulmonary Cancer, Pulmonary Neoplasms, Respiratory Tract Neoplasms, Lung Diseases, Respiratory Tract Diseases, Carcinoma, Bronchogenic, Bronchial Neoplasms, Medullary Thyroid Cancer, Papillary Thyroid Cancer, Thyroid Diseases, Thyroid Neoplasms, Cancer of the Thyroid, Cancer of Thyroid, Neoplasms, Thyroid, Thyroid Adenoma, Thyroid Cancer, Thyroid Carcinoma, Endocrine System Diseases, Endocrine Gland Neoplasms, Head and Neck Neoplasms, Thoracic Neoplasms, CNS tumor, Primary CNS tumor, Colonic Neoplasms, Cancer of Colon, Cancer of the Colon, Colon Cancer, Colon Neoplasms, Colonic Cancer, Neoplasms, Colonic, Malignant tumor of Breast, Mammary Cancer, Mammary Carcinoma, Human, Mammary Neoplasm, Human, Neoplasms, Breast, Tumors, Breast, Human Mammary Carcinoma, Malignant Neoplasm of Breast, Breast Carcinoma, Breast Tumors, Cancer of the Breast, Breast Neoplasms, Breast Cancer, RET Inhibitor, MTC, NSCLC, Soft tissue sarcoma

I'm interested

Share via email

See this study on ClinicalTrials.gov

COG ACNS1931 - A Phase 3 Study of Selumetinib (NSC# 748727, IND# 77782) or Selumetinib in Combination with Vinblastine for non-NF1, non-TSC Patients with Recurrent or Progressive Low-Grade Gliomas (LGGs) Lacking BRAFV600E or IDH1 Mutations

Description:

This phase III trial investigates the best dose of vinblastine in combination with selumetinib and the benefit of adding vinblastine to selumetinib compared to selumetinib alone in treating children and young adults with low-grade glioma (a common type of brain cancer) that has come back after prior treatment (recurrent) or does not respond to therapy (progressive). Selumetinib is a drug that works by blocking a protein that lets tumor cells grow without stopping. Vinblastine blocks cell growth by stopping cell division and may kill cancer cells. Giving selumetinib in combination with vinblastine may work better than selumetinib alone in treating recurrent or progressive low-grade glioma.

Principal Investigator: Christopher Moertel, MD

Sex: All

Age: 2 Years to 25 Years old

System ID: STUDY00018221

IRB Number: STUDY00018221

Show full eligibility criteria

Inclusion Criteria:

Feasibility phase: patients must be >= 2 years and =< 21 years of age at the time of enrollment Efficacy phase: patients must be >= 2 years and =< 25 years of age at the time of enrollment All patients > 21 years of age at the time of enrollment must have had initial diagnosis of low-grade glioma by 21 years of age Patients must have a body surface area (BSA) of >= 0.5 m^2 at enrollment Patients must have eligibility confirmed by rapid central pathology and central molecular screening reviews performed on APEC14B1 Non-neurofibromatosis type 1 (non-NF1), non-tuberous sclerosis complex (non-TSC) low-grade glioma (LGG) without a BRAFV600E or IDH1 mutation Patients must have progressive or recurrent LGG. Note: Biopsy may be at either initial diagnosis or recurrence Patients must have measurable disease, defined as having a two-dimensional measurable tumor volume of >= 1 cm^2 Tumor size will be measured to include both solid and cystic components of the tumor (whether or not tumor is enhancing) + fluid attenuated inversion recovery (FLAIR) signal Eligible histologies will include all tumors considered low-grade glioma or low-grade astrocytoma (World Health Organization [WHO] grade 1 and II) by the WHO Classification of Tumors of the Central Nervous System - 4th Edition Revised, with the exception of subependymal giant cell astrocytoma Patients with metastatic disease or multiple independent primary LGGs are eligible Patients must be progressive or recurrent after having been treated with at least one prior tumor-directed therapy before enrollment Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study Myelosuppressive chemotherapy: Must not have received within 2 weeks of entry onto this study (4 weeks if prior nitrosourea); Biologic (anti-neoplastic agent): At least 7 days since the completion of therapy with a biologic agent; Radiation therapy (RT): >= 2 weeks (wks) for local palliative RT (small port); >= 6 months must have elapsed if prior craniospinal RT or if >= 50% radiation of pelvis; >= 6 wks must have elapsed if other substantial bone marrow (BM) radiation; 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; MEK inhibitor or vinblastine: Must not have received treatment with a MEK inhibitor or vinblastine within 6 months of study enrollment 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 (within 7 days prior to enrollment): 2 to < 6 years: 0.8 mg/dL (male) 0.8 mg/dL (female) 6 to < 10 years: 1 mg/dL (male) 1 mg/dL (female) 10 to < 13 years: 1.2 mg/dL (male) 1.2 mg/dL (female) 13 to < 16 years: 1.5 mg/dL (male) 1.4 mg/dL (female) >= 16 years: 1.7 mg/dL (male) 1.4 mg/dL (female) Total bilirubin =< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment) (children with a diagnosis of Gilbert's syndrome will be allowed on study regardless of their total and indirect [unconjugated] bilirubin levels as long as their direct [conjugated] bilirubin is < 3.1 mg/dL) Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) =< 135 U/L (within 7 days prior to enrollment) Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L Albumin >= 2 g/L (within 7 days prior to enrollment) Left ventricular ejection fraction (LVEF) >= 53% (or institutional normal; if the LVEF result is given as a range of values, then the upper value of the range will be used) by echocardiogram (within 4 weeks prior to enrollment) Corrected QT interval (QTc interval) =< 450 msec by electrocardiogram (EKG) (within 4 weeks prior to enrollment) Absolute neutrophil count >= 1,000/uL (unsupported) (within 7 days prior to enrollment) Platelets >= 100,000/uL (unsupported) (within 7 days prior to enrollment) Hemoglobin >= 8 g/dL (may be supported) (within 7 days prior to enrollment) Patients with a known seizure disorder should be stable and should not have experienced a significant increase in seizure frequency within 2 weeks prior to enrollment Stable neurological examination for >= 1 week HYPERTENSION: Patients 2-17 years of age must have a blood pressure that is =< 95th percentile for age, height, and gender at the time of enrollment (with or without the use of anti-hypertensive medications); Patients >= 18 years of age must have a blood pressure =< 130/80 mmHg at the time of enrollment (with or without the use of anti-hypertensive medications) Note for patients of all ages: Adequate blood pressure can be achieved using medication for the treatment of hypertension All patients must have ophthalmology toxicity assessments performed within 4 weeks prior to enrollment For all patients, an MRI of the brain (with orbital cuts for optic pathway tumors) and/or spine (depending on the site[s] of primary disease) with and without contrast must be performed within 4 weeks prior to enrollment Note: If surgical resection or biopsy is performed at the time of progression or recurrence, a post-operative MRI is required Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age Patients must have the ability to swallow whole capsules

Exclusion Criteria:

Prior therapy with vinblastine and/or a MEK inhibitor is permitted, with the following exceptions: Patients must not have had progressive disease while on therapy with vinblastine or a MEK inhibitor; Patients must not have discontinued vinblastine or selumetinib due to toxicity Patients with a concurrent malignancy or history of treatment (other than surgery) for another tumor within the last year are ineligible Patients with diffuse intrinsic pontine tumors as seen on MRI (> 2/3 of pons involvement on imaging) are not eligible even if biopsy reveals grade I/II histology Patients may not be receiving any other investigational agents Patients must not have known hypersensitivity to selumetinib, vinblastine, or similar compounds CYP3A4 agents: Patients must not have received fluconazole or drugs that are strong inducers or inhibitors of CYP3A4 within 7 days prior to study enrollment Patients with any serious medical or psychiatric illness/condition, including substance use disorders or ophthalmological conditions, likely in the judgment of the investigator to interfere or limit compliance with study requirements/treatment Patients who, in the opinion of the investigator, are not able to comply with the study procedures are not eligible PRE-EXISTING CONDITIONS (CARDIAC): Known genetic disorder that increases risk for coronary artery disease. Note: The presence of dyslipidemia in a family with a history of myocardial infarction is not in itself an exclusion unless there is a known genetic disorder documented; Symptomatic heart failure New York Heart Association (NYHA) class II-IV prior or current cardiomyopathy Severe valvular heart disease History of atrial fibrillation PRE-EXISTING CONDITIONS (OPHTHALMOLOGIC CONDITIONS): Current or past history of central serous retinopathy Current or past history of retinal vein occlusion or retinal detachment Patients with uncontrolled glaucoma If checking pressure is clinically indicated, patients with intraocular pressure (IOP) > 22 mmHg or upper limit of normal (ULN) adjusted by age are not eligible Any multivitamin containing vitamin E must be stopped prior to study enrollment even if it contains less than 100% of the daily recommended dosing for vitamin E Surgery within 2 weeks prior to enrollment, with the exception of a surgical biopsy, placement of a vascular access device or cerebrospinal fluid (CSF) diverting procedure such as endoscopic third ventriculostomy (ETV) and ventriculoperitoneal (VP) shunt Note: Patients must have healed from any prior surgery Patients who have an uncontrolled infection are not eligible Female patients who are pregnant are not eligible since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential Lactating females who plan to breastfeed their infants Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation and for 12 weeks after stopping study therapy are not eligible Note: Women of child-bearing potential and males with sexual partners who are pregnant or who could become pregnant (i.e., women of child-bearing potential) should use effective methods of contraception for the duration of the study and for 12 weeks after stopping study therapy to avoid pregnancy and/or potential adverse effects on the developing embryo All patients and/or their parents or legal guardians must sign a written informed consent All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Interventions: Procedure: Biospecimen Collection, Procedure: Magnetic Resonance Imaging, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Drug: Selumetinib Sulfate, Drug: Vinblastine Sulfate

Conditions: Recurrent Low Grade Astrocytoma, Recurrent WHO Grade 2 Glioma, Refractory Low Grade Astrocytoma, Refractory Low Grade Glioma, Refractory WHO Grade 1 Glioma

I'm interested

Share via email

See this study on ClinicalTrials.gov

MT2013-31:Allogeneic Hematopoietic Cell Transplantation for Inherited Metabolic Disorders and Severe Osteopetrosis following Conditioning with Busulfan (Therapeutic Drug Monitoring), Fludarabine +/- ATG

Description:

To evaluate the ability to achieve high-level donor hematopoietic engraftment (defined as neutrophil recovery by Day +42 post-transplant and ≥ 80% donor cells on the myeloid fraction of peripheral blood at Day +100 post-transplant) using related and unrelated BM, PBSC, or UCB grafts following a reduced intensity conditioning regimen based on targeted-exposure busulfan, fludarabine +/- serotherapy in patients with inherited metabolic disorders and severe osteopetrosis.

Principal Investigator: Paul Orchard

Sex: All

Age: to 55 Years old

Phase: Phase 2

System ID: 1406M51542

IRB Number: 1406M51542

Show full eligibility criteria

Inclusion Criteria:

0 through 55 years of age Adequate graft available Adequate organ function Eligible Diseases: Mucopolysaccharidosis Disorders: MPS IH (Hurler syndrome) MPS II (Hunter syndrome) if the patient has no or minimal evidence of symptomatic neurologic disease but is expected to have a neurologic phenotype MPS VI (Maroteaux-Lamy syndrome) MPS VII (Sly syndrome) Glycoprotein Metabolic Disorders: Alpha mannosidosis Fucosidosis Aspartylglucosaminuria Sphingolipidoses and Recessive Leukodystrophies: Globoid cell leukodystrophy Metachromatic leukodystrophy Niemann-Pick B patients (sphingomyelin deficiency) Niemann-Pick C subtype 2 Peroxisomal Disorders: Adrenoleukodystrophy with cerebral involvement Zellweger syndrome Neonatal Adrenoleukodystrophy Infantile Refsum disease Acyl-CoA-Oxidase Deficiency D-Bifunctional enzyme deficiency Multifunctional enzyme deficiency Alpha-methylacyl-CoA Racmase Deficiency (AMACRD) Mitochondrial Neurogastrointestingal Encephalopathy (MNGIE) Severe Osteopetrosis (OP) Hereditary Leukoencephalopathy with axonal spheroids (HDLS; CSF1R mutation) Other Inherited Metabolic Disorders (IMD): Patients will also be considered who have other life-threatening, rare lysosomal, peroxisomal or other similar inherited disorders characterized by white matter disease or other neurologic manifestations for which there is rationale that transplantation would be of benefit, such as certain patients with Wolman's disease, GM1 gangliosidosis, I-cell disease, Tay-Sachs disease, Sandhoff disease or others. Voluntary written consent

Exclusion Criteria:

Pregnancy - menstruating females must have a negative serum or urine pregnancy test within 14 days of study treatment start Prior myeloablative chemotherapy exposure within 4 months of the start of conditioning on this protocol (patients excluded for this reason may be eligible for other institutional protocols) Uncontrolled bacterial, fungal or viral infections including HIV (including active infection with Aspergillus or other mold within 30 days)

Interventions: Drug: IMD Preparative Regimen, Drug: Osteopetrosis Haploidentical Only Preparative Regimen, Drug: Osteopetrosis Only Preparative Regimen, Biological: Stem Cell Transplantation, Drug: cALD HR-D (High-Risk, Regimen C), Drug: cALD HR-D (High-Risk, Regimen D), Drug: cALD SR-A (Standard-Risk, Regimen A), Drug: cALD SR-B (Standard-Risk, Regimen B)

Conditions: Mucopolysaccharidosis Disorders, Hurler Syndrome, Hunter Syndrome, Maroteaux Lamy Syndrome, Sly Syndrome, Alpha-Mannosidosis, Fucosidosis, Aspartylglucosaminuria, Glycoprotein Metabolic Disorders, Sphingolipidoses, Recessive Leukodystrophies, Globoid Cell Leukodystrophy, Metachromatic Leukodystrophy, Niemann-Pick B, Niemann-Pick C Subtype 2, Sphingomyelin Deficiency, Peroxisomal Disorders, Adrenoleukodystrophy With Cerebral Involvement, Zellweger Syndrome, Neonatal Adrenoleukodystrophy, Infantile Refsum Disease, Acyl-CoA Oxidase Deficiency, D-Bifunctional Enzyme Deficiency, Multifunctional Enzyme Deficiency, Alpha-methylacyl-CoA Racmase Deficiency, Mitochondrial Neurogastrointestingal Encephalopathy, Severe Osteopetrosis, Hereditary Leukoencephalopathy With Axonal Spheroids (HDLS, CSF1R Mutation), Inherited Metabolic Disorders

Keywords: Clinics and Surgery Center (CSC)

I'm interested

Share via email

See this study on ClinicalTrials.gov

Fecal Microbiota Transplant for Postoperative Crohn's Disease

Description:

People with Crohn's disease often need surgery. The gut bacteria of people with Crohn's is associated with Crohn's disease coming back after surgery. Fecal microbiota transplant (FMT) after surgery might be a way to prevent Crohn's disease from coming back after surgery. This study aims to determine if fecal microbiota transplant (FMT) taken by capsules results in the same amount of good bacteria in the guts as FMT by colonoscopy in people with Crohn's disease who have had surgery. Participants will be randomized to get FMT by capsules or colonoscopy. Colonoscopy with biopsies 8-weeks after the FMT will be used to assess the good bacteria in the gut.

Principal Investigator: Byron Vaughn

Sex: All

Age: 18 Years to old

Phase: Phase 1

System ID: STUDY00014833

IRB Number: STUDY00014833

Show full eligibility criteria

Interventions: Biological: Capsule fecal microbiota material (cap-FMT), Biological: Colonoscopic fecal microbiota material (colo-FMT)

Conditions: Crohn Disease

Keywords: Clinics and Surgery Center (CSC)

I'm interested

Share via email

See this study on ClinicalTrials.gov

MT2019-06: A Phase 3 Study Evaluating Gene Therapy by Transplantation of Autologous CD34+ Stem Cells Transduced Ex Vivo with the LentiGlobin BB305 Lentiviral Vector in Subjects with Sickle Cell Disease.

Description:

Evaluate the efficacy of treatment with bb1111 (also known as LentiGlobin BB305 Drug Product for Sickle Cell Disease) in subjects with sickle cell disease (SCD).

Principal Investigator: Ashish Gupta

Sex: All

Age: 2 Years to 50 Years old

Phase: Phase 3

System ID: STUDY00006923

IRB Number: STUDY00006923

Show full eligibility criteria

Inclusion Criteria:

Have a diagnosis of SCD, with either βS/βS, βS/β0, or βS/β+ genotype. Be ≥2 and ≤50 years of age at time of consent. Weigh a minimum of 6 kg. Have a Karnofsky performance status of ≥60 (≥16 years of age) or a Lansky performance status of ≥60 (<16 years of age). Be treated and followed for at least the past 24 months prior to Informed Consent in medical center(s) that maintained detailed records on sickle cell disease history. In the setting of appropriate supportive care measures (e.g., pain management plan), have experienced at least 4 protocol-defined VOEs in the 24 months prior to informed consent. Have either experienced HU failure at any point in the past or must have intolerance to HU (intolerance is defined as the patient being unable to continue to take HU per PI judgment). Female and male subjects of childbearing potential agree to use 1 method of highly effective contraception from Screening to at least 6 months after drug product infusion. Provision of written informed consent for this study by subject, or as applicable, subject's parent(s)/legal guardian(s).

Exclusion Criteria:

Subjects for whom allogeneic hematopoietic stem cell transplantation (allo-HSCT) is medically appropriate per PI judgment and a willing, human leukocyte antigen (HLA)-matched related hematopoietic stem cell donor is available. Severe cerebral vasculopathy, defined by any history of overt ischemic or hemorrhagic stroke, a history of abnormal transcranial Doppler (TCD) or TCD imaging (TCDI) for subjects ≤ 16 years of age (e.g. TCD velocity >200 cm/sec) requiring ongoing chronic transfusions, a Screening TCD or TCDI velocity > 200 cm/sec (central read), a Screening MRA showing > 50% stenosis or occlusion in the circle of Willis (central read), or a Screening MRA showing the presence of Moyamoya (central read). Positive for presence of human immunodeficiency virus type 1 or 2 (HIV-1 or HIV-2), hepatitis B, hepatitis C, human T-lymphotropic virus-1 (HTLV-1), active syphilis. Clinically significant, active bacterial, viral, fungal, or parasitic infection Advanced liver disease, such as clear evidence of liver cirrhosis, active hepatitis or significant fibrosis (based on MRI or liver biopsy) liver iron concentration ≥15 mg/g unless liver biopsy shows no evidence of cirrhosis, active hepatitis or significant fibrosis Inadequate bone marrow function, as defined by an absolute neutrophil count of <1×10^9/L (<0.5×10^9/L for subjects on hydroxyurea treatment) or a platelet count <100×10^9/L. Any contraindications to the use of plerixafor during the mobilization of hematopoietic stem cells and any contraindications to the use of busulfan and any other medicinal products required during the myeloablative conditioning, including hypersensitivity to the active substances or to any of the excipients. Patients needing therapeutic anticoagulation treatment during the period of conditioning through platelet engraftment Unable to receive pRBC transfusion. Prior receipt of an allogeneic transplant. Prior receipt of gene therapy. Any prior or current malignancy or immunodeficiency disorder, except previously treated, non-life threatening, cured tumors such as squamous cell carcinoma of the skin. Immediate family member with a known or suspected Familial Cancer Syndrome. Female subject is breastfeeding, pregnant or will attempt to become pregnant from Screening to at least 6 months after drug product infusion. Any other condition that would render the subject ineligible for HSCT. Participation in another clinical study with an investigational drug within 30 days of screening. Presence of a chromosomal abnormality or genetic mutation that may put the subject at an increased risk of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) per Investigator's judgment. Presence of genetic mutations that result in the inactivation of 2 or more α-globin genes

Interventions: Genetic: bb1111

Conditions: Sickle Cell Disease

I'm interested

Share via email

See this study on ClinicalTrials.gov

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)

Description:

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.

Principal Investigator: Britt Erickson

Sex: Female

Age: 35 Years to 50 Years old

Phase: N/A

System ID: STUDY00012693

IRB Number: STUDY00012693

Show full eligibility criteria

Inclusion Criteria:

Individuals 35-50 years of age, inclusive Patients who are undergoing risk-reducing salpingo-oophorectomy (RRSO) (for the BSO arm) and patients who have declined or elected to defer BSO after proper counselling to clearly explain the standard of care for BRCA1 mutation carriers and are undergoing salpingectomy (for the BLS arm with delayed oophorectomy arm). Concurrently planned hysterectomy with either arm is permitted At least one intact ovary and fallopian tube is in situ at the time of counseling and consent. Prior hysterectomy is allowed provided it did not include bilateral salpingectomy. Prior tubal ligation is allowed if one intact ovary and fallopian tube (with fimbria not removed) are present Positive Clinical Laboratory Improvement Act (CLIA)-approved test results for pathogenic or likely pathogenic germline BRCA1 mutation in the patient. Documentation of the result is required Patients may be premenopausal or menopausal Transvaginal ultrasound (TVUS) and CA-125 within 180 days of registration The patient or a legally authorized representative must provide study-specific informed consent prior to study entry Individuals who are currently pregnant or plan to become pregnant in the future through assisted reproductive technologies and who have received proper counseling are eligible. Individuals who are currently pregnant and plan bilateral salpingectomy at the time of a planned cesarean section are eligible. Patients must understand that they will not be able to become pregnant naturally in the future

Exclusion Criteria:

Individuals with a history of any prior cancer who have received chemotherapy within the past 30 days or radiotherapy to abdomen or pelvis at any prior time Prior history of ovarian cancer, including low malignant potential neoplasms (LMP), primary peritoneal carcinoma, or fallopian tube carcinoma Patients medically unfit for the planned surgical procedure Patients with abnormal screening tests (TVUS, CA-125) suspicious for occult or gross pelvic malignancy or neoplasm within the past 180 days An abnormal TVUS is defined as morphologic or structural variations suspicious for ovarian malignancy or complex cystic lesions (simple cysts < 5 cm in maximal diameter are not exclusionary) An abnormal CA-125 is defined as a level > 50 U/ml in premenopausal individuals if they are not current users of oral contraceptives; an abnormal CA-125 is defined as a level > 40 U/ml for premenopausal individuals who are current users of oral contraceptives. An abnormal CA-125 is defined as a level > 35 U/ml in postmenopausal individuals.

Interventions: Procedure: Bilateral Salpingectomy, Procedure: Bilateral Salpingectomy with Oophorectomy, Procedure: Biospecimen Collection, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Procedure: Transvaginal Ultrasound

Conditions: Ovarian Carcinoma

Keywords: Clinics and Surgery Center (CSC)

I'm interested

Share via email

See this study on ClinicalTrials.gov

Telehealth study assessing the removal of filter ventilation on smoking behavior and biomarkers

Description:

This single-blind, between-subject, randomized, multi-center study will assess the effect of cigarettes with unventilated vs. ventilated filters on smoking behavior and biomarkers of tobacco toxicant exposure. The study uses telehealth and brief in-clinic or curbside visits and will also examine the feasibility of remote collection of multiple biological samples. Subjective measures, alveolar carbon monoxide, blood pressure and cigarettes per day will be collected remotely. Biological samples collected at home will be dropped off at the clinic at a brief clinic or curbside visit where the study cigarettes will be dispensed. Smokers using conventional cigarette brands with filter ventilation of about 16-36% will enter a three phase study. Phase 1 is a 1-week baseline period of smoking usual brand cigarettes; Phase 2 consists of 2 weeks of smoking ventilated cigarettes; and Phase 3 where subjects are randomly assigned to one of two conditions: 1) ventilated cigarettes; or 2) unventilated cigarettes smoked for a 6 week period. Weekly telehealth visits are conducted to collect study measures and subjects attend a brief clinic or curbside visits to pick up study cigarettes and drop off biomarker samples. A follow-up telehealth visit will occur at one-month post intervention.

Principal Investigator: Dorothy Hatsukami

Sex: Male or Female

Age: 18 Years and over

Phase: Phase III

This study is also accepting healthy volunteers

System ID: STUDY00012328

IRB Number: STUDY00012328

Show full eligibility criteria

Interventions: Other: Unventilated Cigarette Filter, Other: Ventilated Cigarette Filter

Conditions: Mental Health & Addiction

Keywords: Filter, Nicotine, Policy, Regulatory, Smoking, Tobacco, Ventilation

I'm interested

Share via email

See this study on ClinicalTrials.gov

MT2013-09C : Umbilical Cord Blood Transplantation Using a Myeloablative Preparative Regimen for the Treatment of Hematological Diseases

Description:

This is a treatment protocol for an unrelated umbilical cord blood transplant (UCBT) using a myeloablative preparative regimen for the treatment of hematological diseases, including, but not limited to acute leukemias. There is no research element except the collection of routine clinical data.

Principal Investigator: Margaret MacMillan, MD

Sex: All

Age: to 55 Years old

Phase: N/A

System ID: 1305M34181

IRB Number: 1305M34181

Show full eligibility criteria

Inclusion Criteria:

Eligible Disease Status Acute Myeloid Leukemia (AML): high risk CR1 (as evidenced by preceding MDS, high risk cytogenetics, ≥ 2 cycles to obtain CR, erythroblastic or megakaryocytic leukemia; CR2+. All patients must be in CR as defined by hematological recovery, AND <5% blasts by light microscopy within the bone marrow with a cellularity of ≥15%. Very high risk pediatric patients with AML: Patients <21 years, however, are eligible with (M2 marrow) with < 25% blasts in marrow after having failed one or more cycles of chemotherapy. Acute Lymphocytic Leukemia (ALL): high risk CR1 as defined by cytogenetics (such as t(9;22), t (1:19), t(4;11), other MLL rearrangements, hypodiploidy, or IKZF1 abnormalities), DNA index < 0.81, > 1 cycle to obtain CR or presence minimal residual disease (MRD). Patients in CR2+ are eligible. All patients must be in CR as defined by hematological recovery, AND <5% blasts by light microscopy within the bone marrow with a cellularity of ≥15%. Very high risk pediatric patients with ALL: patients <21 years are also considered high risk CR1 if they had M2 or M3 marrow at day 42 from the initiation of induction or M3 marrow at the end of induction. They are eligible once they achieved a complete remission. Chronic Myelogenous Leukemia excluding refractory blast crisis: To be eligible in first chronic phase (CP1) patient must have failed or be intolerant to imatinib mesylate. Plasma Cell Leukemia after initial therapy, who achieved at least a partial remission Advanced Myelofibrosis Myelodysplasia (MDS) IPSS INT-2 or High Risk (i.e. RAEB, RAEBt) or Refractory Anemia with severe pancytopenia or high risk cytogenetics: Blasts must be < 10% by a representative bone marrow aspirate morphology. Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Marginal Zone B-Cell Lymphoma or Follicular Lymphoma are eligible if there was disease progression/relapse within 12 of achieving a partial or complete remission. Patients who had remissions lasting > 12 months, are eligible after at least two prior therapies. Patients with bulky disease (nodal mass greater than 5 cm) should be considered for de-bulking chemotherapy before transplant. Lymphoplasmacytic Lymphoma, Mantle-Cell Lymphoma, Prolymphocytic Leukemia are eligible after initial therapy in CR1+ or PR1+. Large Cell NHL > CR2/> PR2: Patients in CR2/PR2 with initial short remission (<6 months) are eligible. Lymphoblastic Lymphoma, Burkitt's Lymphoma, and other high-grade NHL after initial therapy if stage III/IV in CR1/PR1 or after progression if stage I/II < 1 year. Multiple Myeloma beyond PR2: Patients with chromosome 13 abnormalities, first response lasting less than 6 months, or β-2 microglobulin > 3 mg/L, may be considered for this protocol after initial therapy. Myeloproliferative Syndromes Availability of suitable UCB unit(s) 0 to 55 years Voluntary written consent (adult or parental/guardian)

Exclusion Criteria:

previous irradiation that precludes the safe administration of TBI - Radiation Oncology will evaluate all patients who have had previous radiation therapy chemotherapy refractory large cell and high grade NHL (ie progressive disease after > 2 salvage regimens) if ≤ 18 years old, prior myeloablative transplant within the last 6 months. If >18 years old prior myeloablative allotransplant or autologous transplant extensive prior therapy including > 12 months alkylator therapy or > 6 months alkylator therapy with extensive radiation pregnant or breastfeeding HIV positive

Interventions: Drug: Cyclophosphamide, Drug: Cyclosporine A, Drug: Fludarabine, Drug: Mycophenylate mofetil, Radiation: Total Body Irradiation, Biological: Umbilical cord blood

Conditions: Acute Myeloid Leukemia (AML), Acute Lymphocytic Leukemia (ALL), Chronic Myelogenous Leukemia, Plasma Cell Leukemia, Myelofibrosis, Myelodysplasia, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Marginal Zone B-Cell Lymphoma, Follicular Lymphoma, Lymphoplasmacytic Lymphoma, Mantle-Cell Lymphoma, Prolymphocytic Leukemia, Diffuse Large B Cell Lymphoma, Lymphoblastic Lymphoma, Burkitt's Lymphoma, Non-Hodgkin Lymphoma, Multiple Myeloma

Keywords: Clinics and Surgery Center (CSC)

I'm interested

Share via email

See this study on ClinicalTrials.gov

Microbiome and Immunsuppression: The Mission Study (MISSION)

Description:

A prospective, observational microbiome study of adult kidney transplant recipients receiving mycophenolate mofetil and tacrolimus maintenance immunosuppression. Participants will be studied post-transplant for mycophenolate pharmacokinetics and microbiome samples collected. Clinically measured tacrolimus trough concentrations will also be evaluated. Associations among mycophenolic acid enterohepatic recycling and metabolite formation, tacrolimus troughs, immunosuppression adverse effects, diarrhea and microbiome will be studied.

Principal Investigator: Pamala Jacobson

Sex: All

Age: 18 Years to old

System ID: STUDY00007227

IRB Number: STUDY00007227

Show full eligibility criteria

Interventions: Other: collection of body microbioma

Conditions: Kidney Transplant Rejection, Kidney Transplant

Keywords: Clinics and Surgery Center (CSC)

I'm interested

Share via email

See this study on ClinicalTrials.gov

Prolonged Daily Fasting As a Viable Alternative to Caloric Restriction in At-Risk Obese Humans

Principal Investigator: Lisa Chow

Sex: Male or Female

Age: 18 Years and over

Phase: N/A

This study is also accepting healthy volunteers

System ID: STUDY00008545

IRB Number: STUDY00008545

Show full eligibility criteria

Interventions: Behavioral: Caloric Restriction (CR), Behavioral: Time Restricted Eating (TRE)

Conditions: Obesity

Keywords: Clinics and Surgery Center (CSC)

I'm interested

Share via email

See this study on ClinicalTrials.gov

Long-term toxicities and quality of life of cancer survivors treated with immunotherapy

Description:

Immunotherapies, such as immune checkpoint inhibitors, have greatly improved survival for many cancers and are now approved for over half of all cancer patients. However, many patients receiving immunotherapy experience Grade 3 and 4 toxicities, termed immune-related adverse events (IRAEs) which cause frequent hospitalizations, emergency department visits, impaired health-related quality of life (QOL) and often discontinuation of therapy. While clinical trials of immunotherapeutic drugs have reported on IRAEs over short time-periods, the real-life and long-term frequencies of and experiences with IRAEs outside of clinical trials, and the general experience of taking immunotherapies long-term remain unknown. The goal of this protocol is to build a prospective cohort study of cancer survivors who receive immunotherapies.

Principal Investigator: Rachel Vogel

Sex: Male or Female

Age: 18 Years and over

System ID: STUDY00016320

IRB Number: STUDY00016320

Show full eligibility criteria

Conditions: Cancer

Keywords: immunotherapy, Clinics and Surgery Center (CSC)

I'm interested

Share via email

A Prospective, Multi-Center, Single-Arm, Open-Label, Observational Study on the Safety and Effectiveness of the ProSomnus EVO Sleep and Snore Device in the Treatment of Severe Obstructive Sleep Apnea

Description:

The primary objectives of this study are to evaluate the therapeutic effectiveness and safety profile of the ProSomnus EVO Sleep and Snore Device in individuals with severe obstructive sleep apnea (OSA). The secondary objective is to evaluate the effect of the EVO Sleep and Snore Device on Epworth Sleepiness Scale (ESS) scores.

Principal Investigator: Bimaje Akpa

Sex: Male or Female

Age: 18 Years and over

System ID: STUDY00016436

IRB Number: STUDY00016436

Show full eligibility criteria

Interventions: Device: ProSomnus® EVO Sleep and Snore Device

Conditions: Breathing, Lung & Sleep Health

Keywords: Oral Appliance, Obstructive Sleep Apnea, Sleep Apnea, ProSomnus EVO Sleep and Snore Device

I'm interested

Share via email

See this study on ClinicalTrials.gov

A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF CK3773274 IN ADULTS WITH SYMPTOMATIC HYPERTROPHIC CARDIOMYOPATHY AND LEFT VENTRICULAR OUTFLOW TRACT OBSTRUCTION (SEQUOIA-HCM)

Description:

Hypertrophic cardiomyopathy (HCM) is a disease of the cardiac sarcomere for which the fundamental pathophysiologic abnormality is myocardial hypercontractility leading to cardiac hypertrophy. In patients with obstructive HCM (oHCM), dynamic left ventricular outflow tract (LVOT) obstruction creates a high-pressure outflow tract gradient during systole. Patients with oHCM often develop signs and symptoms of heart failure. CK-3773274 is a small molecule cardiac myosin inhibitor being developed as a chronic, oral treatment for patients with HCM. CK-3773274 is designed to reduce the hypercontractility that underlies the pathophysiology of HCM. Selective inhibition of cardiac myosin with CK-3773274 may yield potential advantages over current therapies for oHCM by directly reducing myocardial hypercontractility and addressing the fundamental cause of this sarcomeric disease. In the Phase 2 trial, CY 6021 (REDWOOD-HCM), patients with oHCM received up to three doses of CK-3773274 or placebo (randomized 2:1) in a dose escalating manner using echocardiography to guide dose titration. Two cohorts of approximately 20 patients each were enrolled and treated for 10 weeks. Doses in the first cohort were 5, 10, 15 mg once daily; the second cohort studied 10, 20, and 30 mg once daily. In both cohorts, CK-3773274 significantly and substantially reduced the LVOT gradient (LVOT-G) in a dose and exposure dependent manner. There were no treatment interruptions or discontinuations, nor any treatment related serious adverse events. The results from this trial support progression of CK-3773274 to Phase 3 given the association between reductions in LVOT-G and improvements in patient symptoms and function. This trial will evaluate the effects of treatment with CK-3773274 over a 24-week period on cardiopulmonary exercise capacity and health status in patients with symptomatic oHCM.

Principal Investigator: Jeremy Markowitz

Sex: All

Age: 18 Years to 85 Years old

System ID: STUDY00016948

IRB Number: STUDY00016948

Show full eligibility criteria

Key

Inclusion Criteria:

Males and females between 18 and 85 years of age, inclusive, at screening. Body mass index <35 kg/m2. Diagnosed with HCM per the following criteria: Has LV hypertrophy and non-dilated LV chamber in the absence of other cardiac disease and Has an end-diastolic LV wall thickness as measured by the echocardiography core laboratory of: ≥15 mm in one or more myocardial segments OR ≥13 mm in one or more wall segments and a known-disease-causing gene mutation or positive family history of HCM Has resting LVOT-G ≥30 mmHg and post-Valsalva LVOT G ≥50 mmHg during screening as determined by the echocardiography core laboratory. LVEF ≥60% at screening as determined by the echocardiography core laboratory. NYHA Functional Class II or III at screening. Hemoglobin ≥10g/dL at screening. Respiratory exchange ratio (RER) ≥1.05 and pVO2 <80% predicted on the screening CPET per the core laboratory. Patients on beta-blockers, verapamil, diltiazem, or disopyramide should have been on stable doses for >6 weeks prior to randomization and anticipate remaining on the same medication regimen during the trial. Patients treated with disopyramide must also be concomitantly treated with a beta blocker and/or calcium channel blocker. Key

Exclusion Criteria:

Known or suspected infiltrative, genetic or storage disorder causing cardiac hypertrophy that mimics oHCM (eg, Noonan syndrome, Fabry disease, amyloidosis). Significant valvular heart disease (per investigator judgment). Moderate-severe valvular aortic stenosis. Moderate-severe mitral regurgitation not due to systolic anterior motion of the mitral valve. History of LV systolic dysfunction (LVEF <45%) or stress cardiomyopathy at any time during their clinical course. Inability to exercise on a treadmill or bicycle (eg, orthopedic limitations). Has been treated with septal reduction therapy (surgical myectomy or percutaneous alcohol septal ablation) or has plans for either treatment during the trial period. Documented paroxysmal atrial fibrillation during the screening period. Paroxysmal or permanent atrial fibrillation requiring rhythm restoring treatment (eg, direct-current cardioversion, atrial fibrillation ablation procedure, or antiarrhythmic therapy) ≤6 months prior to screening. (This exclusion does not apply if atrial fibrillation has been treated with anticoagulation and adequately rate-controlled for >6 months.) History of syncope or sustained ventricular tachyarrhythmia with exercise within 6 months prior to screening. Has received prior treatment with CK-3773274 or mavacamten.

Interventions: Drug: CK-3773274 (5 mg, 10 mg, 15 mg and 20 mg), Drug: Placebo to match CK-3773274

Conditions: Obstructive Hypertrophic Cardiomyopathy (oHCM)

Keywords: Clinics and Surgery Center (CSC)

I'm interested

Share via email

See this study on ClinicalTrials.gov

Treatment of Refractory Nausea

Principal Investigator: Kiran Lassi

Sex: Female

Age: 18 Years and over

System ID: MMCORC057

IRB Number: MMCORC057

Show full eligibility criteria

Interventions: Drug: Dexamethasone, Other: Laboratory Biomarker Analysis, Drug: Netupitant/Palonosetron Hydrochloride, Drug: Olanzapine, Other: Placebo, Drug: Prochlorperazine, Other: Quality-of-Life Assessment

Conditions: Cancer

Keywords: Breast Cancer, Breast Cancer, Chemotherapy, Nausea

I'm interested

Share via email

See this study on ClinicalTrials.gov

Internet-delivered Management of Pain Among Cancer Treatment Survivors (IMPACTS)

Principal Investigator: Edward Greeno, M.D.

Sex: Male or Female

Age: 18 Years and over

System ID: MMCORC055

IRB Number: MMCORC055

Show full eligibility criteria

Interventions: Behavioral: Internet-based pain coping skills program

Conditions: Cancer

Keywords: Cancer Pain, Cancer Survivors, Cancer Survivorship

I'm interested

Share via email

See this study on ClinicalTrials.gov

A Phase II Randomized Trial of Olaparib (NSC-747856) Administered Concurrently With Radiotherapy Versus Radiotherapy Alone for Inflammatory Breast Cancer

Principal Investigator: Kiran Lassi

Sex: Male or Female

Age: 18 Years and over

System ID: MMCORC051

IRB Number: MMCORC051

Show full eligibility criteria

Interventions: Drug: Olaparib, Radiation: Radiation Therapy

Conditions: Cancer

Keywords: Breast Cancer, Breast Cancer, Inflammatory Breast Cancer

I'm interested

Share via email

See this study on ClinicalTrials.gov

CORRECT-MRD II: Second Colorectal Cancer Clinical Validation Study to Predict Recurrence Using a Circulating Tumor DNA Assay to Detect Minimal Residual Disease (MRD)

Principal Investigator: Edward Greeno, M.D.

Sex: Male or Female

Age: 18 Years and over

System ID: MMCORC050

IRB Number: MMCORC050

Show full eligibility criteria

Interventions: Device: MRD

Conditions: Cancer

Keywords: Colon Cancer, Colon Cancer, Colorectal Cancer

I'm interested

Share via email

See this study on ClinicalTrials.gov

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

Principal Investigator: Rahel Ghebre, Dr

Sex: Female

Age: 18 Years and over

System ID: MMCORC048

IRB Number: MMCORC048

Show full eligibility criteria

Interventions: Drug: Carboplatin, Drug: Letrozole, Drug: Paclitaxel

Conditions: Cancer

Keywords: Fallopian Tube cancer, Ovarian cancer, Peritoneal cancer, Serous carcinoma

I'm interested

Share via email

See this study on ClinicalTrials.gov

A Phase III Clinical Trial Evaluating De-Escalation of Breast Radiation for Conservative Treatment of Stage I, Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer (DEBRA)

Principal Investigator: Jocelin Huang

Sex: Male or Female

Age: 18 Years and over

System ID: MMCORC044

IRB Number: MMCORC044

Show full eligibility criteria

Interventions: Drug: Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane), Other: Radiation and Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)

Conditions: Cancer

Keywords: Breast Cancer, Breast Cancer, Radiation, Stage 1 breast cancer. Hormone positive breast cancer

I'm interested

Share via email

See this study on ClinicalTrials.gov

A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer)

Principal Investigator: Kiran Lassi

Sex: Male or Female

Age: 18 Years and over

System ID: MMCORC041

IRB Number: MMCORC041

Show full eligibility criteria

Interventions: Drug: Endocrine Therapy of Physician's Choice, Drug: Giredestrant, Drug: LHRH Agonist

Conditions: Cancer

Keywords: Breast Cancer, Breast Cancer, chemotherapy, Hormone positive breast cancer

I'm interested

Share via email

See this study on ClinicalTrials.gov

EA1181 (CompassHER2-pCR): Preoperative THP and postoperative HP in patients who achieve a pathologic complete response

Description:

This trial studies how well paclitaxel, trastuzumab, and pertuzumab work in eliminating further chemotherapy after surgery in people with HER2-positive stage II-IIIa breast cancer who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after pre-operative chemotherapy and HER2-targeted therapy. We will compare outcomes of this treatment to those of the people receiving the usual treatment after surgery.

Principal Investigator: Nicole Hartung

Sex: Male or Female

Age: 18 Years and over

System ID: MMCORC025

IRB Number: MMCORC025

Show full eligibility criteria

Interventions: Drug: Docetaxel, Procedure: Lumpectomy, Procedure: Mastectomy, Drug: Nab-paclitaxel, Drug: Paclitaxel, Biological: Pertuzumab, Radiation: Radiation Therapy, Biological: Trastuzumab, Biological: Trastuzumab Emtansine

Conditions: Cancer

Keywords: Breast Cancer, Breast Cancer, Chemotherapy, HER2 positive

I'm interested

Share via email

See this study on ClinicalTrials.gov

RANDOMIZED NON-INFERIORITY TRIAL COMPARING OVERALL SURVIVAL OF PATIENTS MONITORED WITH SERUM TUMOR MARKER DIRECTED DISEASE MONITORING (STMDDM) VERSUS USUAL CARE IN PATIENTS WITH METASTATIC HORMONE RECEPTOR POSITIVE HER-2 NEGATIVE BREAST CANCER

Description:

This study is looking at how well serum tumor markers work to monitor people who have hormone receptor positive Her2 negative breast cancer that has spread to other places in the body. We want to see if using the markers (from a blood sample) is as good as using scans to monitor disease.

Principal Investigator: Nicole Hartung

Sex: Male or Female

Age: 18 Years and over

System ID: MMCORC021

IRB Number: MMCORC021

Show full eligibility criteria

Interventions: Other: Anxiety Questionnaire Administration, Other: Quality-of-Life Assessment, Other: Serum Tumor Marker directed disease monitoring, Other: Usual care disease monitoring

Conditions: Cancer

Keywords: Breast Cancer, Breast Cancer, Tumor Markers, Metastatic Breast Cancer

I'm interested

Share via email

See this study on ClinicalTrials.gov

A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel with or without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer

Description:

We are studying the addition of a drug to the treatment for people who have triple-negative breast cancer. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells. Some people will receive the current treatment and others will have the current treatment with carboplatin added. The results of the two treatments will be compared.

Principal Investigator: Edward Greeno, M.D.

Sex: Male or Female

Age: 18 Years and over

System ID: MMCORC003

IRB Number: MMCORC003

Show full eligibility criteria

Interventions: Drug: Carboplatin, Drug: Cyclophosphamide, Drug: Doxorubicin Hydrochloride, Other: Laboratory Biomarker Analysis, Drug: Paclitaxel

Conditions: Cancer

Keywords: Breast Cancer, Breast Cancer, Triple Negative Breast Cancer

I'm interested

Share via email

See this study on ClinicalTrials.gov

A Phase II Study of Pembrolizumab Monotherapy in Recurrent Ovarian Cancer of the Immunoreactive Subtype determined by NanoString Gene Expression Profiling

Description:

To evaluate clinical anti-tumor activity of pembrolizumab monotherapy based on ORR as assessed by the investigator per irRECIST in patients with ROC whose tumors show an immunoreactive gene expression signature

Principal Investigator: Boris Winterhoff

Sex: Female

Age: 18 Years to old

Phase: Phase 2

System ID: STUDY00006054

IRB Number: STUDY00006054

Show full eligibility criteria

Inclusion Criteria:

Be willing and able to provide written informed consent/assent for the trial Have received 1-5 prior lines for treating ROC (i.e. 2-6 total prior lines counting the front line) and must have a platinum-free interval (PFI) or a treatment-free interval (TFI) >= 3 months based on the last regimen received Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Note: Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale Have histologically diagnosed recurrent epithelial ovarian, fallopian or primary peritoneal ovarian cancer Have provided a tumor tissue sample either collected from a newly obtained tumor tissue biopsy or an archival tissue specimen. Subjects for whom newly obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived biopsy specimen. Formalin-fixed paraffin embedded (FFPE) block specimens are preferred to 20 unstained slides. Additional samples may be requested if tumor tissue provided is not adequate for quality and/or quantity as assessed by the central laboratory Performed within 10 days of treatment initiation: absolute neutrophil count (ANC) >= 1,500/mcL Performed within 10 days of treatment initiation: platelets >= 100,000/mcL Performed within 10 days of treatment initiation: hemoglobin >= 9 g/dL or >= 5.6 mmol/L without transfusion or erythropoietin (EPO) dependency (within 7 days of assessment) Performed within 10 days of treatment initiation: serum creatinine OR measured or calculated creatinine clearance (CrCl) (glomerular filtration rate [GFR] can also be used in place of creatinine or CrCl) =< 1.5 x upper limit of normal (ULN) OR >= 45 mL/min for subject with creatinine levels > 1.5 x institutional ULN Creatinine clearance should be calculated per institutional standard Performed within 10 days of treatment initiation: serum total bilirubin =<1.5 x ULN OR direct bilirubin =< ULN for subjects with total bilirubin levels > 1.5 ULN Performed within 10 days of treatment initiation: aspartate aminotransferase (AST) (serum glutamate pyruvate transaminase [SGOT]) and aspartate aminotransferase (ALT) (serum glutamic-oxaloacetic transaminase [SGPT]) =< 2.5 x ULN OR =< 5 x ULN for subjects with liver metastases Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required Have received front line platinum-based chemotherapy (preoperative chemotherapy is allowed) Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject

Exclusion Criteria:

Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 2 weeks of the first dose of treatment Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment Has a known history of active TB (Bacillus Tuberculosis) Hypersensitivity to pembrolizumab or any of its excipients Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study day 1 or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 1 or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to a previously administered agent Note: Subjects with =< grade 2 neuropathy are an exception to this criterion and may qualify for the study Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment Has known history of, or any evidence of active, non-infectious pneumonitis Has an active infection requiring systemic therapy Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject?s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies) Has known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected) Has received a live vaccine within 30 days of planned start of study therapy Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed

Interventions: Biological: Pembrolizumab

Conditions: Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma

Keywords: Clinics and Surgery Center (CSC)

I'm interested

Share via email

See this study on ClinicalTrials.gov

Pomalidomide for the Treatment of Bleeding in Hereditary Hemorrhagic Telangiectasia (PATH-HHT)

Description:

This is a Phase II placebo-controlled double-blind study of pomalidomide in patients with hereditary hemorrhagic telangiectasia (HHT) with moderate to severe epistaxis who require parenteral iron infusions or blood transfusions.

Principal Investigator: Holly Boyer

Sex: Male or Female

Age: 18 Years and over

System ID: STUDY00013859

IRB Number: STUDY00013859

Show full eligibility criteria

Interventions: Drug: Placebo oral capsule, Drug: Pomalidomide Oral Product

Conditions: Blood Disorders, Ear, Nose & Throat

Keywords: HHT, Pomalidomide, nose bleeds, nose, Hereditary Hemorrhagic Telangiectasia

I'm interested

Share via email

See this study on ClinicalTrials.gov

COG AALL1621 - A Phase 2 Study of Inotuzumab Ozogamicin (NSC# 772518, IND#133494) in Children and Young Adults with Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukemia (B-ALL)

Description:

This phase II trial studies how well inotuzumab ozogamicin works in treating younger patients (≥1 year and < 22 years ) with CD22 positive B acute lymphoblastic leukemia that has come back or does not respond to treatment. Immunotoxins, such as inotuzumab ozogamicin, are antibodies linked to a toxic substance and may help find cancer cells that express CD22 and kill them without harming normal cells.

Principal Investigator: Peter Gordon

Sex: All

Age: 1 Year to 21 Years old

Phase: Phase 2

System ID: STUDY00002494

IRB Number: STUDY00002494

Show full eligibility criteria

Inclusion Criteria:

Patients must be >= 1 year and < 22 years of age at the time of enrollment Patients must have B-ALL, or previously diagnosed B lymphoblastic lymphoma (B-LL), with >= 5% (M2 or M3) bone marrow blasts with or without extramedullary disease NOTE: Relapsed patients previously diagnosed with B-lymphoblastic lymphoma (B-LL) are eligible if they have an M2 or M3 marrow at the time of enrollment on this study Patients with ALL or B-LL who have M2 morphology must have local confirmatory testing showing >= 5% blasts by flow cytometry, fluorescence in situ hybridization (FISH) testing or other molecular method Leukemic blasts must demonstrate surface expression of CD22 at the time of relapse by local/institutional flow cytometry of a bone marrow aspirate sample; (assessment of CD22 using a bright fluorophore such as phycoerythrin [PE] is strongly recommended) In the case of an inadequate aspirate sample (dry tap) or if bone marrow aspirate is unable to be performed due to patient clinical status, flow cytometry of peripheral blood specimen may be substituted if the patient has at least 1,000/uL circulating blasts; alternatively, CD22 expression may be documented by immunohistochemistry of a bone marrow biopsy specimen Patients with one of the following: Second or greater relapse; Primary refractory disease with at least 2 prior induction attempts; First relapse refractory to at least one prior re-induction attempt Any relapse after HSCT (Cohort 1 ONLY) Patients with Down syndrome are eligible ONLY for Cohort 1 with: Any of above disease status, OR First relapse with no prior re-induction attempt NOTE: Patients with Down syndrome or prior HSCT are NOT eligible for Cohort 2 combination therapy Patients with Philadelphia chromosome (Ph)+ ALL must have had two prior therapy attempts including two different tyrosine kinase inhibitors (TKIs) Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy, defined as resolution of all such toxicities to =< grade 2 or lower per the inclusion/exclusion criteria prior to entering this study. Apply to Cohort 2: 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. A waiting period prior to enrollment is not required for patients receiving standard cytotoxic maintenance chemotherapy (i.e., corticosteroid, vincristine, 6MP, and/or methotrexate). A waiting period is not required for patients receiving a single dose of intrathecal methotrexate, hydrocortisone, and/or cytarabine within 7 days prior to enrollment >= 14 days must have elapsed after the completion of other cytotoxic therapy, with the exception of hydroxyurea, for patients not receiving standard maintenance therapy. For patients who previously received calaspargase pegol, >= 21 days must have elapsed after the last dose. Additionally, patients must have fully recovered from all acute toxic effects of prior therapy. Note: Cytoreduction with hydroxyurea must be discontinued >= 24 hours prior to the start of protocol therapy. 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. 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. Anti-cancer agents that are 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. There is an exception for blinatumomab infusions, for which patients must have been off for at least 3 days and all drug related toxicity must have resolved to grade 2 or lower as outlined in the inclusion/exclusion criteria. Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid. A waiting period prior to enrollment is not required for patients receiving corticosteroid for leukemia therapy/cytoreduction. Radiotherapy: >= 2 weeks must have elapsed since local palliative radiation therapy (XRT) (small port); >= 3 months must have elapsed if prior cranial or craniospinal XRT was received, if >= 50% of the pelvis was irradiated, or if total body irradiation (TBI) was received; >= 6 weeks must have elapsed if other substantial bone marrow irradiation was given. Stem cell transplant or rescue without TBI: For Cohort 1, at least 90 days must have elapsed since stem cell transplant and at least 30 days from donor lymphocyte infusion. Patient must have had no more than one previous HSCT and currently have no evidence of active graft vs. host disease (GVHD). For Cohort 2, no prior HSCT is allowed. Chimeric antigen receptor (CAR) T cell therapy: At least 30 days must have elapsed from the last CAR-T cell infusion Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age; 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 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: 1 to < 2 years: maximum serum creatinine 0.6 mg/dL (both male and female) 2 to < 6 years: maximum serum creatinine 0.8 mg/dL (both male and female) 6 to < 10 years: maximum serum creatinine 1 mg/dL (both male and female) 10 to < 13 years: maximum serum creatinine 1.2 mg/dL (both male and female) 13 to < 16 years: maximum serum creatinine 1.5 mg/dL (male), 1.4 mg/dL (female) >= 16 years: maximum serum creatinine 1.7 mg/dL (male), 1.4 mg/dL (female) Direct bilirubin =< 1.5 x upper limit of normal (ULN) for age, and Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) =< 5 x ULN for age; for the purpose of this study, the ULN for ALT will be 45 U/L

Exclusion Criteria:

Patients with any prior history of SOS irrespective of severity Patients with isolated central nervous system (CNS), testicular, or any other extramedullary site of relapse Patients who have been previously treated with inotuzumab ozogamicin Patients who have previously received HSCT (Cohort 2 only) Patients with Down syndrome (Cohort 2 only) History of allergic reaction attributed to compounds of similar or biologic composition to inotuzumab ozogamicin or other agents in the study Note: Patients with history of allergy to pegaspargase/calaspargase pegol are eligible for enrollment on Cohort 2 (dose levels 1 and -1) if Erwinia formulation of asparaginase can be obtained If Cohort 2 is enrolling at dose level -2, then patients who cannot receive asparaginase due to prior allergy, toxicity, or lack of access may enroll NOTE: patients on AALL1621 are not eligible to co-enroll on AALL1931 Patients with active optic nerve and/or retinal involvement are not eligible; patients who are presenting with visual disturbances should have an ophthalmologic exam and, if indicated, a magnetic resonance imaging (MRI) to assess optic nerve or retinal involvement Patients who are currently receiving another investigational drug Patients who are currently receiving or plan to receive other anti-cancer agents (except hydroxyurea, which may be continued until 24 hours prior to start of protocol therapy, and intrathecal chemotherapy) Anti-GVHD or agents to prevent organ rejection post-transplant; patients who are receiving cyclosporine, tacrolimus, or other agents to prevent either graft-versus-host disease post bone marrow transplant or organ rejection post-transplant are not eligible for this trial; at least 3 half-lives must have elapsed after the last dose of GVHD or anti-rejection medications Patients who are currently receiving or plan to receive corticosteroids except as described below Systemic corticosteroids may be administered for cytoreduction up to 24 hours prior to the start of protocol therapy, (Cohort 1 only) for all patients, corticosteroids may be administered as a premedication for inotuzumab ozogamicin and as treatment for allergic reactions or for physiologic replacement/stress dosing of hydrocortisone for documented adrenal insufficiency; corticosteroids are not allowed for other indications Patients with known human immunodeficiency virus (HIV), hepatitis B or C infections; testing to prove negative status is not required for enrollment unless it is deemed necessary for usual medical care of the patient Patients who have an active uncontrolled infection defined as: Positive bacterial blood culture within 48 hours of study enrollment; Fever above 38.2 degree Celsius (C) within 48 hours of study enrollment with clinical signs of infection; fever that is determined to be due to tumor burden is allowed if patients have documented negative blood cultures for at least 48 hours prior to enrollment and no concurrent signs or symptoms of active infection or hemodynamic instability A positive fungal culture within 30 days of study enrollment or active therapy for presumed invasive fungal infection Patients may be receiving IV or oral antibiotics to complete a course of therapy for a prior documented infection as long as cultures have been negative for at least 48 hours and signs or symptoms of active infection have resolved; for patients with clostridium (C.) difficile diarrhea, at least 72 hours of antibacterial therapy must have elapsed and stools must have normalized to baseline Active viral or protozoal infection requiring IV treatment Patients known to have one of the following concomitant genetic syndromes: Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Schwachman (Schwachman-Diamond-Blackfan) syndrome or any other known bone marrow failure syndrome There have been no human studies of inotuzumab ozogamicin in pregnant women and no reports of exposure in utero; based on nonclinical safety studies, inotuzumab ozogamicin has the potential to impair human male and female fertility and to adversely affect human embryo fetal development; women of childbearing potential should be advised to avoid becoming pregnant while receiving inotuzumab ozogamicin; there is no information regarding the presence of inotuzumab ozogamicin in human milk, the effects on the breast-fed infant, or the effects on milk production; because of the potential for adverse reactions in breast-fed infants, women should not breast-feed during treatment with inotuzumab ozogamicin and for at least 2 months after the final dose Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained within 7 days prior to enrollment Female patients who are sexually active and of reproductive potential are not eligible unless they agree to use an effective contraceptive method for the duration of their study participation and for 8 months after the last dose of inotuzumab ozogamicin Men with female partners of childbearing potential should use effective contraception during treatment with inotuzumab ozogamicin and for at least 5 months after the last dose of inotuzumab ozogamicin Lactating females are not eligible unless they agree not to breastfeed their infants

Interventions: Procedure: Biospecimen Collection, Procedure: Bone Marrow Aspiration and Biopsy, Drug: Calaspargase Pegol, Drug: Cyclophosphamide, Drug: Cytarabine, Procedure: Diagnostic Imaging, Biological: Inotuzumab Ozogamicin, Drug: Leucovorin Calcium, Procedure: Lumbar Puncture, Drug: Methotrexate, Drug: Pegaspargase, Drug: Vincristine

Conditions: Recurrent B Acute Lymphoblastic Leukemia, Recurrent B Lymphoblastic Lymphoma, Refractory B Acute Lymphoblastic Leukemia, Refractory B Lymphoblastic Lymphoma

I'm interested

Share via email

See this study on ClinicalTrials.gov

A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy? System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression (RECOVER)

Description:

This blinded, randomized, multicenter controlled study is intended to collect evidence that VNS Therapy as an adjunctive therapy improves health outcomes for patients with TRD. The objective of this study is to determine whether active VNS Therapy treatment improves health outcomes for Treatment Resistant Depression (TRD) subjects compared to a no stimulation control in depressive symptoms. This prospective, multicenter trial is composed of two parts: - The RCT and Follow-up (RCT) is a randomized, controlled, blinded trial to determine if active VNS Therapy treatment compared to a no stimulation control improves depressive symptoms. - The Longitudinal Registry (LR) is an observational, open label, single arm study aimed at assessing the long-term effectiveness and safety of VNS Treatment.

Principal Investigator: Ziad Nahas

Sex: All

Age: 18 Years to old

Phase: N/A

System ID: STUDY00009412

IRB Number: STUDY00009412

Show full eligibility criteria

Interventions: Device: Vagus Nerve Stimulation (VNS)

Conditions: Treatment Resistant Depression

Keywords: VNS, Depression, TRD

I'm interested

Share via email

See this study on ClinicalTrials.gov

Search Results

Email this study information to me

Contact the study team