29
Participants
Start Date
July 31, 2010
Primary Completion Date
August 31, 2013
Study Completion Date
June 30, 2014
Temozolomide
Dose level selection will proceed according to the modified Accelerated Titration Design. The starting dose will be TMZ 200mg/m2 x 0.09 BSA for the upper extremity and 200mg/m2 x 0.18 BSA for the lower extremity. We will enroll one-patient cohorts with dose doubling between cohorts until 1st occurrence of a ≥ CTC (Common Terminology Criteria) grade 2 adverse event. At that time, the present cohort and all future cohorts will be extended to enroll 3 to 6 patients.
Duke University Medical Center, Durham
Moffitt Cancer Center, Tampa
MD Anderson Cancer Center, Houston
Collaborators (1)
Merck Sharp & Dohme LLC
INDUSTRY
Duke University
OTHER
M.D. Anderson Cancer Center
OTHER
H. Lee Moffitt Cancer Center and Research Institute
OTHER
Douglas Tyler
OTHER