21
Participants
Start Date
November 5, 2012
Primary Completion Date
March 1, 2022
Study Completion Date
March 1, 2022
Whole Brain Radiotherapy (WBRT)
WBRT (30 Gy) will be delivered in 10 fractions. Standard opposed lateral fields with multileaf collimation blocking will be used. Treatment will be administered on business days and delivered over an approximate 2 week period. Dexamethasone may be given at the discretion of the treating physician but the dose cannot exceed greater than 16mg daily as it is a strong CYP3A4 inducer. Patients will also receive a proton pump inhibitor with dexamethasone.
Sorafenib
The proposed three dose levels of sorafenib during dose escalation are 200 mg, 400mg, and 600 mg administered daily orally. Patients will be enrolled in cohorts of 3.The first three subjects will take sorafenib 200 mg daily within a few hours after the first RT fraction. Sorafenib will be continued concurrently with WBRT (1 fraction /day x 10 fractions) without breaks and then continued after WBRTfor a total of 21 days. If no dose limiting toxicity (DLT) is observed in a cohort of 3 patients until two weeks after completion of WBRT, the next dose level will be evaluated.
Memorial Sloan Kettering Cancer Center, New York
Memorial Sloan Kettering Westchester, Harrison
Memorial Sloan Kettering Nassau, Uniondale
Memorial Sloan Kettering Cancer Center @ Suffolk, Commack
Memoral Sloan Kettering Cancer Center, Basking Ridge
Memorial Sloan Kettering Monmouth, Middletown
Collaborators (1)
Bayer
INDUSTRY
Memorial Sloan Kettering Cancer Center
OTHER