Recruitment

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