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

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.

Completed

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Key information

Conditions

Malignant Glioma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Kentuckiana Cancer Institute

Louisville, Kentucky, 40202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Irinotecan (Camptosar, CPT-11)

Drug

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.

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

Sponsors and collaborators

Lead sponsor

Kentuckiana Cancer Institute

Other

Registry information

Official study title

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

Important dates

Study start: 2001
Primary completion: 2008
Study completion: 2008
First posted: Jan 30, 2006
Registry last updated: Jan 20, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed