Phase I/II Study of High Dose Irinotecan (Camptosar, CPT-11) in Patients With Recurrent Unresectable Malignant Glioma on Steroids/Anti-epileptics
Overview
- Phase
- Phase 1
- Intervention
- Irinotecan (Camptosar, CPT-11)
- Conditions
- Malignant Glioma
- Sponsor
- Kentuckiana Cancer Institute
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 16 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Cohort #1
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.
Intervention: Irinotecan (Camptosar, CPT-11)
Cohort #2
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.
Intervention: Irinotecan (Camptosar, CPT-11)
Cohort #3
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.
Intervention: Irinotecan (Camptosar, CPT-11)
Outcomes
Primary Outcomes
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.
Time Frame: 2008