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

NCT00283556 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2010-01-20

No results posted yet for this study

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.

Conditions

  • Malignant Glioma

Interventions

DRUG

Irinotecan (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.

Sponsors & Collaborators

  • Kentuckiana Cancer Institute

    lead OTHER

Principal Investigators

  • Renato V. LaRocca, MD · Director

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-08-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00283556 on ClinicalTrials.gov