Olaparib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Defects in DNA Damage Repair Genes (A Pediatric MATCH Treatment Trial)
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- National Cancer Institute (NCI)
- Study ID
- NCT03233204
- Phase
- PHASE2
- Status
- Completed
Conditions
- Advanced Malignant Solid Neoplasm
- Ann Arbor Stage III Childhood Non-Hodgkin Lymphoma
- Ann Arbor Stage IV Childhood Non-Hodgkin Lymphoma
- Low Grade Glioma
- Malignant Glioma
- Recurrent Childhood Central Nervous System Neoplasm
- Recurrent Childhood Ependymoma
- Recurrent Childhood Malignant Germ Cell Tumor
- Recurrent Childhood Non-Hodgkin Lymphoma
- Recurrent Childhood Rhabdomyosarcoma
- Recurrent Childhood Soft Tissue Sarcoma
- Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
- Recurrent Glioma
- Recurrent Hepatoblastoma
- Recurrent Langerhans Cell Histiocytosis
- Recurrent Malignant Solid Neoplasm
- Recurrent Medulloblastoma
- Recurrent Neuroblastoma
- Recurrent Osteosarcoma
- Refractory Childhood Malignant Germ Cell Tumor
- Refractory Ependymoma
- Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
- Refractory Glioma
- Refractory Hepatoblastoma
- Refractory Langerhans Cell Histiocytosis
- Refractory Malignant Glioma
- Refractory Malignant Solid Neoplasm
- Refractory Medulloblastoma
- Refractory Neuroblastoma
- Refractory Non-Hodgkin Lymphoma
- Refractory Osteosarcoma
- Refractory Primary Central Nervous System Neoplasm
- Refractory Rhabdomyosarcoma
- Refractory Soft Tissue Sarcoma
- Rhabdoid Tumor
- Wilms Tumor
Eligibility Criteria
- Sex
- ALL
- Age
- 12 Months - 21 Years
- Healthy Volunteers
- Not accepted
Interventions
- Olaparib — DRUGGiven PO
Study Details
This phase II Pediatric MATCH trial studies how well olaparib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with defects in deoxyribonucleic acid (DNA) damage repair genes that have spread to other places in the body (advanced) and have come back (relapsed) or do not respond to treatment (refractory). Olaparib is an inhibitor of PARP, an enzyme that helps repair DNA when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy.
Key Dates
- Start date
- Sep 14, 2017
- Status verified
- Dec 2024
- Primary completion
- Mar 31, 2023
- Completion
- Jun 30, 2024
Study Design
- Enrollment
- 6 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment (olaparib)Patients receive olaparib PO BID on days 1-28. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.
Primary Outcome Measure
Objective Response Rate (Complete Response/Partial Response) [ Time Frame: Up to 2 years from study entry ]
Locations (111)
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