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Gliadel Wafer, Temozolomide and Radiation Therapy for Newly Diagnosed GBM

NCT00548938 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2009-09-18

No results posted yet for this study

Summary

The purpose of this study is to determine the safety and efficacy of the combination of Gliadel wafers plus surgery and limited field radiation therapy with concomitant temozolomide followed by temozolomide given at an extended dose schedule (metronomic schedule) in patients undergoing initial surgery for newly-diagnosed high grade glioma.

Conditions

Interventions

DRUG

Gliadel wafer

Implanted at surgery

DRUG

Temozolomide

During External Beam Radiation

RADIATION

External Beam Radiation Therapy

60 Gy

Sponsors & Collaborators

  • Methodist Healthcare

    lead OTHER

Principal Investigators

  • Allen K Sills, MD · Methodist University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
72 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2009-10-31
Completion
2010-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT00548938 on ClinicalTrials.gov