Clinical Trials Logo

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

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

See also
  Status Clinical Trial Phase
Recruiting NCT02910895 - A Platform of Patient Derived Xenografts (PDX) and 2D/3D Cell Cultures of Soft Tissue Sarcomas (STS) N/A
Recruiting NCT05621668 - A First-In-Human Phase 1 Trial of T-Cell Membrane-Anchored Tumor Targeted Il12 (Attil12)- T-Cell Therapy in Subjects With Advanced/Metastatic Soft Tissue and Bone Sarcoma Phase 1
Active, not recruiting NCT04032964 - Dose Finding Study of L19TNF and Doxorubicin in Patients With STS Phase 1
Active, not recruiting NCT04577014 - Retifanlimab (Anti-PD-1 Antibody) With Gemcitabine and Docetaxel in Patients With Advanced Soft Tissue Sarcoma Phase 1/Phase 2
Completed NCT01650077 - Therapeutic Response of Patients With Soft Tissue Sarcoma According to CHOI Criteria
Withdrawn NCT04906876 - A Phase 2 Study of 9-ING-41Combined With Chemotherapy in Adolescents and Adults With Advanced Sarcomas Phase 2
Terminated NCT02890368 - Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Solid Tumors and Mycosis Fungoides Phase 1
Terminated NCT02628535 - Safety Study of MGD009 in B7-H3-expressing Tumors Phase 1
Completed NCT02204111 - Patient Directed Intervention to Improve the Quality of Life for Patients With Soft Tissue Sarcoma
Withdrawn NCT01663090 - Ferumoxytol-Enhanced MRI in Adult/Pedi Sarcomas N/A
Completed NCT01259375 - Amrubicin Chemotherapy as First Line in Metastatic or Unresectable Soft Tissue Sarcoma Phase 2
Completed NCT01440088 - A Trial of TH-302 in Combination With Doxorubicin Versus Doxorubicin Alone to Treat Patients With Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma Phase 3
Completed NCT01106872 - Bevacizumab, Chemotherapy and Valproic Acid in Advanced Sarcomas Phase 1
Recruiting NCT00753727 - Sunitinib and Radiation in Patients With Resectable Soft-tissue Sarcoma Phase 1/Phase 2
Terminated NCT00755261 - Phase II Study of Doxorubicin and Avastin® in Sarcoma. Phase 2
Completed NCT00611078 - Environmental Pollutants and the Risk of Soft Tissue Sarcoma: A Pilot Study N/A
Completed NCT00580320 - Safety Study of Dacarbazine and Bortezomib in Melanoma and Soft Tissue Sarcoma Phase 1
Completed NCT03452644 - US-Guided Biopsy in the Diagnosis of Musculoskeletal Soft-Tissue Tumors
Recruiting NCT05539677 - Biobank and Register of Patients With Agresive Tumors for Translational and Analytical Research
Terminated NCT03520959 - A Phase 3, Randomized, Double-blind, Placebo-controlled Study For Subjects With Locally-advanced Unresectable or Metastatic Synovial Sarcoma (V943-003, IMDZ-04-1702) Phase 3