Vemurafenib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With BRAF V600 Mutations (A Pediatric MATCH Treatment Trial)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Ann Arbor Stage III Childhood Non-Hodgkin Lymphoma
- Advanced Malignant Solid Neoplasm
- Ann Arbor Stage IV Childhood Non-Hodgkin Lymphoma
- Ependymoma
- Ewing Sarcoma
- Refractory Non Hodgkin Lymphoma
- Refractory Primary Central Nervous System Neoplasm
- Hepatoblastoma
- Rhabdomyosarcoma
- Recurrent Malignant Solid Neoplasm
- Langerhan's Cell Histiocytosis
- Refractory Neuroblastoma
- Refractory Malignant Solid Neoplasm
- Rhabdoid Tumor
- Recurrent Childhood Non-Hodgkin Lymphoma
- Soft Tissue Sarcoma
- Recurrent Neuroblastoma
- Malignant Germ Cell Tumor
- Malignant Glioma
- Osteosarcoma
- Wilm's Tumor
- Peripheral Primitive Neuroectodermal Tumor
- Recurrent Childhood Central Nervous System Neoplasm
- 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 OBJECTIVE: I. To determine the objective response rate (ORR; complete response + partial response) in pediatric patients treated with vemurafenib with advanced solid tumors (including central nervous system [CNS] tumors), lymphomas or histiocytic disorders that harbor activating BRAF V600 mu...
PRIMARY OBJECTIVE: I. To determine the objective response rate (ORR; complete response + partial response) in pediatric patients treated with vemurafenib with advanced solid tumors (including central nervous system [CNS] tumors), lymphomas or histiocytic disorders that harbor activating BRAF V600 mutations. SECONDARY OBJECTIVES: I. To estimate the progression free survival in pediatric patients treated with vemurafenib with advanced solid tumors (including CNS tumors), lymphomas or histiocytic disorders that harbor activating BRAF V600 mutations. II. To obtain information about the tolerability of vemurafenib in children with relapsed or refractory cancer. EXPLORATORY OBJECTIVE: I. To explore approaches to profiling changes in tumor genomics over time through evaluation of circulating tumor deoxyribonucleic acid (DNA). OUTLINE: Patients receive vemurafenib orally (PO) twice daily (BID) on day 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Tracking Information
- NCT #
- NCT03220035
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: AeRang Kim Children's Oncology Group