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Phase II Study of Irinotecan HCI for Recurrent Anaplastic Astrocytomas, Mixed Malignant Gliomas, and Oligodendrogliomas

NCT00360828 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2017-03-23

Study results available
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Summary

Phase 2 trial to explore the efficacy and safety of irinotecan (CPT-11). Also administered at each cycle was zofran/Kytril/Anzemet, decadron, and IV atropine.

At each cycle, patient exams and interviews as well as lab results were to help the research team to determine the symptomatic side effects of the treatment. Recorded past toxicities were to be compared with current side effects.

Conditions

Interventions

DRUG

Irinotecan Hydrochloride (HCI) Treatment

Irinotecan injections. Irinotecan hydrochloride \[CPT-11; CAMPTOSAR\] is an antineoplastic agent of the topoisomerase I inhibitor class. The drug is supplied in amber vials and appears as a pale yellow transparent aqueous solution. Two vial sizes are available: 2 mL vials containing 40 mg of drug and 5 mL vials containing 100 mg of drug. A treatment cycle was 21 days. Patients were treated for a minimum of 3 cycles (doses) of CPT-11 or until their disease progressed.

DRUG

Continued Irinotecan Hydrochloride (HCI) Treatment

For patients responding to treatment, therapy could have continued beyond 18 cycles.

Sponsors & Collaborators

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Edward Pan, MD · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00360828 on ClinicalTrials.gov