A Phase I Study of Vemurafenib in Adolescents with Inoperable Stage IIIC/IV Melanoma with V600 BRAF Mutations

Protocol
11-198
Full Title
An Open-label, Multicenter, Single-arm, Phase I Dose-escalation with Efficacy Tail Extension Study of RO5185426 in Pediatric Patients with Surgically Incurable and Unresectable Stage IIIC or Stage IV Melanoma Harboring BRAFV600 Mutations (NO25390)
Phase
I
Disease Status
Newly Diagnosed & Relapsed/Refractory
Purpose

Vemurafenib is approved for treating metastatic melanoma. It works by inhibiting the activity of BRAF, a protein which, when mutated, drives the growth of metastatic melanoma. Vemurafenib is approved specifically for adult patients with a BRAF mutation called V600.

Vemurafenib has not been assessed in patients with melanoma younger than age 18. The purpose of this study is to find the highest dose of vemurafenib that can be given safely in adolescents (age 12-17) with inoperable stage IIIC/IV melanoma that contains a V600 BRAF mutation.

Investigator
Pratilas, Christine, MD
Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have stage IIIC/IV melanoma that contains a V600 BRAF mutation.
  • Patients’ tumors must be surgically incurable or inoperable.
  • Patients must be between the ages of 12 and 17.
  • Patients may have newly diagnosed disease or may have previously received therapy.
  • At least 2 weeks must have passed since completion of prior treatment and entry into the study.

For more information and to inquire about eligibility for this study, please contact Dr. Stephen W. Gilheeney at 212-639-3973.

Disease(s)
Melanoma
Locations
Related Diseases