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NCT00283556 Clinical Trial

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

Malignant Glioma Clinical Trial

Official title:
Phase I/II Study of High Dose Irinotecan (Camptosar, CPT-11) in Patients With Recurrent Unresectable Malignant Glioma on Steroids/Anti-epileptics

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00283556
Other study ID # 1068114
Secondary ID 44OE-ONC-0020-3
Status Completed
Phase Phase 1/Phase 2
First received January 26, 2006
Last updated January 18, 2010
Start date August 2001
Est. completion date December 2008

Study information
Verified date January 2010
Source Kentuckiana Cancer Institute
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 30
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Irinotecan (Camptosar, CPT-11)
Cohort #1--Irinotecan 750 mg/m2 IV over 90 minutes Q 3 weeks x 15 patients; Cohort #2--Irinotecan 500 mg/m2 IV over 90 minutes Q 2 weeks x 3 patients; 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.

Locations
Country Name City State
United States Kentuckiana Cancer Institute Louisville Kentucky

Sponsors (1)
Lead Sponsor Collaborator
Kentuckiana Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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