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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00283556

Enrollment

Registered

2006-01-30

Start date

2001-08-31

Completion date

2008-12-31

Last updated

2010-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Glioma

Keywords

High Dose Irinotecan, CPT-11, Camptosar, Malignant Glioma, Unresectable

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.

Interventions

DRUGIrinotecan (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.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026