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)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Recurrent Childhood Central Nervous System Neoplasm
- Advanced Malignant Solid Neoplasm
- Ann Arbor Stage III Childhood Non-Hodgkin Lymphoma
- Refractory Primary Central Nervous System Neoplasm
- Ann Arbor Stage IV Childhood Non-Hodgkin Lymphoma
- Low Grade Glioma
- Malignant Glioma
- Refractory Medulloblastoma
- Recurrent Childhood Ependymoma
- Refractory Ependymoma
- Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
- Refractory Langerhans Cell Histiocytosis
- Refractory Rhabdomyosarcoma
- Rhabdoid Tumor
- Refractory Malignant Solid Neoplasm
- Refractory Non Hodgkin Lymphoma
- Wilm's Tumor
- Refractory Childhood Malignant Germ Cell Tumor
- Recurrent Childhood Malignant Germ Cell Tumor
- Refractory Malignant Glioma
- Recurrent Langerhans Cell Histiocytosis
- Recurrent Childhood Non-Hodgkin Lymphoma
- Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
- Recurrent Hepatoblastoma
- Recurrent Childhood Rhabdomyosarcoma
- Refractory Osteosarcoma
- Refractory Soft Tissue Sarcoma
- Recurrent Neuroblastoma
- Refractory Neuroblastoma
- Recurrent Glioma
- Recurrent Malignant Solid Neoplasm
- Recurrent Osteosarcoma
- Refractory Glioma
- Recurrent Childhood Soft Tissue Sarcoma
- Recurrent Medulloblastoma
- Refractory Hepatoblastoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 1221 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. To determine the objective response rate (ORR; complete response + partial response) in pediatric patients treated with olaparib with advanced solid tumors (including central nervous system [CNS] tumors), non-Hodgkin lymphomas or histiocytic disorders that harbor activating ge...
PRIMARY OBJECTIVES: I. To determine the objective response rate (ORR; complete response + partial response) in pediatric patients treated with olaparib with advanced solid tumors (including central nervous system [CNS] tumors), non-Hodgkin lymphomas or histiocytic disorders that harbor activating genetic alterations in the deleterious genetic alterations in the DNA damage repair (DDR) pathway. SECONDARY OBJECTIVES: I. To estimate the progression free survival in pediatric patients treated with olaparib with advanced solid tumors including non-Hodgkin lymphomas, CNS tumors, and histiocytosis that harbor deleterious genetic alterations in the DDR pathway. II. To obtain information about the tolerability of olaparib in children and adolescents with relapsed or refractory cancer. III. To provide preliminary estimates of the pharmacokinetics of olaparib in children and adolescents with relapsed or refractory cancer. EXPLORATORY OBJECTIVES: I. To explore approaches to profiling changes in tumor genomics over time through the evaluation of circulating tumor DNA. OUTLINE: Patients receive olaparib orally (PO) twice daily (BID) on days 1-28. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.
Tracking Information
- NCT #
- NCT03233204
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Julia Glade-Bender Children's Oncology Group
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