Ph. II Treatment of Adults w Primary Malignant Glioma w Irinotecan + Temozolomide

PHASE2CompletedINTERVENTIONAL
Enrollment

41

Participants

Timeline

Start Date

November 30, 2005

Primary Completion Date

July 31, 2007

Study Completion Date

June 30, 2009

Conditions
Glioblastoma
Interventions
DRUG

Temodar and Irinotecan

Temozolomide-orally 200mg/m2 in fasting state 1hr prior to CPT-11 infusion. Temozolomide-day 1 of treatment cycle \& every 24hrs thereafter for 5days w treatment cycles repeated every 6wks. Treatment cycles repeated up to maxi of 3 cycles until occurrence of either unacceptable toxicity/evidence of disease progression. CPT-11-intravenously in fasting state over 90min. CPT-11 1hr after Temozolomide administration on day 1 of treatment cycle. CPT-11-days 1, 8, 22, \& 29 of 6wk treatment cycle. Treatment cycles may be repeated up to maxi of 3 cycles until occurrence of either unacceptable toxicity/evidence of disease progression. Dose of CPT-11 will be based on whether pt is receiving EIAEDs due to increased drug clearance produced by agents. For pts receiving EIAEDs, CPT-11 dose of 325mg/m2 administered. For pts not receiving EIAEDs, CPT-11 dose of 125mg/m2 administered.

Trial Locations (1)

27710

Duke University Health System, Durham

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

lead

Duke University

OTHER