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

Part of paid clinical trials in Durham, North Carolina.

Sponsor: Duke University
Study ID: NCT00616005
Phase: PHASE2
Status: Completed

Conditions

Glioblastoma

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Temodar and Irinotecan — DRUG
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.

Study Details

Objective: To determine activity of combo of Irinotecan + Temozolomide To further characterize any toxicity associated w combo of Irinotecan + Temozolomide