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A Study of Gliadel Followed by Avastin + Irinotecan for Glioblastoma Multiforme (GBM)

NCT00735436 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2013-02-11

Study results available
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Summary

The primary objective of the study is to use 24 week survival to assess the efficacy of the combination of Gliadel followed by Avastin and irinotecan in the treatment of grade IV malignant glioma patients following surgical resection. The secondary objectives are to determine the progression-free survival following the combination of Gliadel followed by Avastin and irinotecan and to describe the toxicity of Gliadel followed by Avastin and irinotecan.

Conditions

Interventions

DRUG

Gliadel/Avastin/CPT-11

Sponsors & Collaborators

  • Eisai Inc.

    collaborator INDUSTRY

  • Genentech, Inc.

    collaborator INDUSTRY

  • Duke University

    lead OTHER

Principal Investigators

  • Annick Desjardins, MD, FRCPC · Duke University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2011-07-31
Completion
2012-10-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT00735436 on ClinicalTrials.gov