28
Participants
Start Date
November 30, 2006
Primary Completion Date
June 30, 2013
Study Completion Date
June 30, 2013
Genasense® (oblimersen)
Cohorts 1 and 2: Genasense 7 mg/kg/day by continuous intravenous infusion beginning on Day 1 and continuing for 7 days (Week 1) and beginning again on Day 22 and continuing for 7 days (Week 4); Cohort 3: Genasense 900 mg as a 1-hour intravenous infusion on Day 1, 4, 8, and 11 (Weeks 1 and 2) and Day 22, 25, 29, and 32 (Weeks 4 and 5).
Abraxane® (paclitaxel protein-bound particles for injectable suspension)
Cohorts 1 and 2: Abraxane 175 mg/m2 or 260 mg/m2 as a 30-minute intravenous infusion on Day 8 and Day 29 following end of Genasense continuous infusion; Cohort 3: Abraxane 175 mg/m2 as a 30-minute intravenous infusion on Day 4 and Day 25 following end of Genasense 1-hour infusion
Temodar® (temozolomide)
Cohorts 1-3: Temodar 75 mg/m2/day orally on Days 1 through 42 (Week 1 through Week 6)
New York University Cancer Center, New York
Lead Sponsor
Genta Incorporated
INDUSTRY