High Dose Camptothecin-11 (CPT-11) in Recurrent Unresectable Malignant Glioma

Phase 1

Completed

• Conditions: Malignant Glioma
• Interventions: Drug: Irinotecan (Camptosar, CPT-11)

• 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.

Study Timeline

• Study Start: 2001-08
• Study First Submitted: 2006-01-26
• Study First Submitted QC: 2006-01-26
• Study First Posted: 2006-01-30
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-18
• Last Update Posted: 2010-01-20

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

Trial Locations

Locations (1)

Kentuckiana Cancer Institute; 🇺🇸 Louisville, Kentucky, United States