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A Phase II Study of Gliadel, Concomitant Temozolomide and Radiation, Followed By Dose Dense Therapy With Temozolomide For Newly Diagnosed Malignant High Grade Glioma

NCT00660283 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2010-01-20

No results posted yet for this study

Summary

To determine the safety and efficacy of surgical resection with Gliadel® 3.85% wafer implantation, followed by concomitant limited field radiation therapy and temozolomide, followed by dose dense temozolomide in subjects undergoing initial surgery for newly-diagnosed high grade glioma.

Conditions

Interventions

DRUG

Temozolomide

(Stage I Treatment) Postoperative concomitant limited-field radiation therapy with daily temozolomide (75 mg/m2) must begin between 14 and 28 days from surgery. 7\. (Stage II Treatment) temozolomide 150 mg/m2 to be given days 1-7 and 15-21 of a 28 day cycle to begin within 45 days of stop date of concomitant limited field radiation/daily temozolomide (Stage I treatment) up to a maximum of 12 cycles.

Sponsors & Collaborators

  • Eisai Inc.

    collaborator INDUSTRY

  • Kentuckiana Cancer Institute

    lead OTHER

Principal Investigators

  • Renato V LaRocca, MD · Kentuckiana Cancer Instititue

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States

Study Locations

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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 NCT00660283 on ClinicalTrials.gov