Overview

Ph I 5-day Temozolomide + O6-BG in Treatment of Pts w Recurrent / Progressive GBM

Status:
Completed
Trial end date:
2008-07-01
Target enrollment:
Participant gender:
Summary
Primary objectives To determine maxi tolerated dose of Temodar® in combo w O6-benzylguanine administered for 5 consecutive days in pts w progressive/recurrent GBM To characterize toxicity associated w Temodar® in combo w O6-BG administered for 5 consecutive days in pts w progressive/recurrent GBM To determine Neulasta®-supported MTD defined as the MTD of Temodar® in combo with O6-BG administered for 5 days while receiving Neulasta® once per treatment cycle between days 7 & 14 in pts w progressive/recurrent GBM To obtain preliminary response rates of Temodar® in combo w O6-BG administered for 5 consecutive days in pts w progressive/recurrent GBM
Phase:
Phase 1
Details
Lead Sponsor:
Duke University
Collaborators:
Keryx / AOI Pharmaceuticals, Inc.
Schering-Plough
Treatments:
Dacarbazine
O(6)-benzylguanine
Temozolomide