Phase I/II Study of High Dose Irinotecan (Camptosar, CPT-11) in Patients With Recurrent Unresectable Malignant Glioma on Steroids/Anti-epileptics
18 Years
N/A
Both
Malignant Glioma
Trial Information
Phase I/II Study of High Dose Irinotecan (Camptosar, CPT-11) in Patients With Recurrent Unresectable Malignant Glioma on Steroids/Anti-epileptics
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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.
Outcome Time Frame:
2008
Principal Investigator
Renato V. LaRocca, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Director
Authority:
United States: Institutional Review Board
Study ID:
1068114
NCT ID:
NCT00283556
Start Date:
August 2001
Completion Date:
December 2008
Related Keywords:
- Malignant Glioma
- High Dose Irinotecan
- CPT-11
- Camptosar
- Malignant Glioma
- Unresectable
- Glioma
Name | Location |
|---|---|
| Kentuckiana Cancer Institute | Louisville, Kentucky 40202 |
