MedTrace Logo

Vemurafenib Combined With Whole Brain Radiation Therapy or Radiosurgery in Patients With BRAF Mutation-Positive Melanoma and Brain Metastases

NCT02145910 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2025-05-02

No results posted yet for this study

Summary

This phase I trial studies the best dose of vemurafenib when combined with whole brain radiation therapy (WBRT) or stereotactic radiosurgery (SRS) in patients with v-raf murine sarcoma viral oncogene homolog B (BRAF) mutation-positive melanoma and brain metastases. Radiation therapy is an effective treatment for patients with brain metastases. Patients with multiple metastases are typically treated with WBRT. For patients with a few metastases, SRS alone can be used. Vemurafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Combining radiation treatment with vemurafenib for melanoma patients with brain metastases may result in improved local control and prolonged survival.

Conditions

  • Recurrent Melanoma
  • Stage IV Melanoma
  • Tumors Metastatic to Brain

Interventions

DRUG

Vemurafenib

Given PO

RADIATION

Whole-brain radiation therapy (WBRT)

Undergo WBRT

RADIATION

Radiosurgery (SRS)

Undergo SRS

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Sidney Kimmel Cancer Center at Thomas Jefferson University

    lead OTHER

Principal Investigators

  • Wenyin Shi, MD, PhD · Thomas Jefferson University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Primary Completion
2019-06-30

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02145910 on ClinicalTrials.gov