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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)

Soft Tissue Sarcoma Clinical Trial

Official title:
NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice)- Phase 2 Subprotocol of Vemurafenib in Patients With Tumors Harboring BRAF V600 Mutations

Clinical Trial Summary

This phase II Pediatric MATCH trial studies how well vemurafenib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with BRAF V600 mutations that have spread to other places in the body (advanced) and have come back (recurrent) or do not respond to treatment (refractory). Vemurafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Clinical Trial 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 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. ;

Study Design

Related Conditions & MeSH terms

  • Advanced Malignant Solid Neoplasm
  • Ann Arbor Stage III Childhood Non-Hodgkin Lymphoma
  • Ann Arbor Stage IV Childhood Non-Hodgkin Lymphoma
  • Central Nervous System Neoplasms
  • Ependymoma
  • Ewing Sarcoma
  • Glioma
  • Hepatoblastoma
  • Histiocytosis
  • Histiocytosis, Langerhans-Cell
  • Langerhans Cell Histiocytosis
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Malignant Germ Cell Tumor
  • Malignant Glioma
  • Neoplasms
  • Nervous System Neoplasms
  • Neuroblastoma
  • Neuroectodermal Tumors
  • Neuroectodermal Tumors, Primitive
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Osteosarcoma
  • Peripheral Primitive Neuroectodermal Tumor
  • Recurrence
  • Recurrent Childhood Central Nervous System Neoplasm
  • Recurrent Childhood Non-Hodgkin Lymphoma
  • Recurrent Malignant Solid Neoplasm
  • Recurrent Neuroblastoma
  • Refractory Malignant Solid Neoplasm
  • Refractory Neuroblastoma
  • Refractory Non-Hodgkin Lymphoma
  • Refractory Primary Central Nervous System Neoplasm
  • Rhabdoid Tumor
  • Rhabdomyosarcoma
  • Sarcoma
  • Sarcoma, Ewing
  • Soft Tissue Sarcoma
  • Wilms Tumor
Clinical Trial Details
NCT number NCT03220035
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Active, not recruiting
Phase Phase 2
Start date November 8, 2017
Completion date September 22, 2024
View Details
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