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)

  • STATUS
    Not Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    49
  • sponsor
    National Cancer Institute (NCI)
Updated on 9 May 2022
platelet count
cancer
corticosteroids
ascites
stem cell transplantation
graft versus host disease
total body irradiation
lymphoma
hodgkin's disease
metastatic disease
nitrosoureas
tumor markers
cytokines
measurable disease
interferon
growth factor
pleural effusion
stem cell infusion
MRI
bone marrow procedure
glomerular filtration rate
colony stimulating factor
hematopoietic growth factors
BRAF
cytotoxic chemotherapy
gm-csf
metastasis
neutrophil count
tumor cells
blood transfusion
positron emission tomography
cancer treatment
nitrosourea
chemotherapeutic agents
cancer chemotherapy
interleukins
cancer therapy
antineoplastic
solid tumour
solid tumor
stem cell transplant
blood count
cns metastases
match treatment
radiopharmaceutical therapy
antibody therapy
cns tumors
platelet transfusion
radiopharmaceutical
131i-mibg
iobenguane
autologous stem cell infusion
pegfilgrastim
braf inhibitor
myelosuppressive chemotherapy
donor lymphocyte infusion
cellular therapy
platelet transfusions
anti-cancer agents
cns tumor
vemurafenib
cns neoplasm
pleural effusions
central nervous system tumor
hematopoietic stem cell transplantation
braf v600 mutation
mg++
dabrafenib
bone marrow infiltration
encorafenib

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.

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.

Details
Condition Advanced Malignant Solid Neoplasm, Ann Arbor Stage III Childhood Non-Hodgkin Lymphoma, Ann Arbor Stage IV Childhood Non-Hodgkin Lymphoma, Ependymoma, Ewing Sarcoma, Hepatoblastoma, Langerhans Cell Histiocytosis, Malignant Germ Cell Tumor, Malignant Glioma, Osteosarcoma, Peripheral Primitive Neuroectodermal Tumor, 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, Soft Tissue Sarcoma, Wilms Tumor
Treatment laboratory biomarker analysis, Vemurafenib
Clinical Study IdentifierNCT03220035
SponsorNational Cancer Institute (NCI)
Last Modified on9 May 2022

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