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Irinotecan in Treating Patients With Recurrent Glioma

2014-08-27 03:58:48 | BioPortfolio

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who have recurrent glioma.

Description

OBJECTIVES: I. Determine the efficacy of irinotecan in the treatment of patients with recurrent glioma. II. Assess the toxicities of irinotecan in these patients. III. Correlate the pharmacological parameters with toxicity and response to therapy.

OUTLINE: This is a two arm study. Patients are stratified according to prior nitrosourea administration. Patients are assigned to 1 of 2 arms, with only 1 arm being open at any time. Patients assigned to arm I receive irinotecan IV over 90 minutes on days 1, 8, 15, and 22. This is followed by a 2 week rest and continues for a maximum of 6 courses. Patients assigned to arm II receive irinotecan on day 1 every 3 weeks for up to 12 courses. Patients in both arms who received prior nitrosoureas receive reduced starting doses of irinotecan. The dosages may be increased once per patient after the first course if toxic effects are acceptable. Arm I closed as of 10/98, Arm II open as of 10/98. Patients are followed every 3 months for the first year, every 6 months for the next 4 years, then annually until death.

PROJECTED ACCRUAL: This study will accrue 30 patients in each treatment arm in 24 months, for a total of 60 patients.

Study Design

Primary Purpose: Treatment

Conditions

Brain and Central Nervous System Tumors

Intervention

irinotecan hydrochloride

Location

CCOP - Scottsdale Oncology Program
Scottsdale
Arizona
United States
85259-5404

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:58:48-0400

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Neoplasms of the intracranial components of the central nervous system, including the cerebral hemispheres, basal ganglia, hypothalamus, thalamus, brain stem, and cerebellum. Brain neoplasms are subdivided into primary (originating from brain tissue) and secondary (i.e., metastatic) forms. Primary neoplasms are subdivided into benign and malignant forms. In general, brain tumors may also be classified by age of onset, histologic type, or presenting location in the brain.

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