High Dose Camptothecin-11 (CPT-11) in Recurrent Unresectable Malignant Glioma
- Registration Number
- NCT00283556
- Lead Sponsor
- Kentuckiana Cancer Institute
- Brief Summary
The purpose of this study is to compare the response to treatment and side effects associated with high dose irinotecan in patients with recurrent brain tumors.
- Detailed Description
This is a phase I/II study of high dose irinotecan in patients with recurrent unresectable malignant glioma on steroids/anti-epileptics. The purpose is to compare the response to treatment and side effects associated with high dose irinotecan in patients with recurrent brain tumors.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- recurrent, unresectable primary CNS neoplasm per MRI
- ECOG status of 2 or less
- no prior therapy with camptothecans
- on an enzyme-inducing antiepileptic
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cohort #2 Irinotecan (Camptosar, CPT-11) Cohort #2--Irinotecan 500 mg/m2 IV over 90 minutes Q 2 weeks x 3 patients. Additional increments of 50 mg/m2 for subsequent cohorts until MTD is reached. Cohort #1 Irinotecan (Camptosar, CPT-11) Cohort #1--Irinotecan 750 mg/m2 IV over 90 minutes every (Q) 3 weeks x 15 patients. Additional increments of 50 mg/m2 for subsequent cohorts until MTD is reached. Cohort #3 Irinotecan (Camptosar, CPT-11) Cohort #3--Irinotecan 600 mg/m2 IV over 90 minutes Q 2 weeks x 3 patients. Additional increments of 50 mg/m2 for subsequent cohorts until MTD is reached.
- Primary Outcome Measures
Name Time Method The purpose of this study is to compare the response to treatment and side effects associated with high dose irinotecan in patients with recurrent brain tumors. 2008
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Kentuckiana Cancer Institute
🇺🇸Louisville, Kentucky, United States