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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Malignant Glioma

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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 InstituteLouisville, Kentucky  40202