Radiation With Concomitant and Then Sequential Temozolomide in Malignant Glioma

October 30, 2007 updated by: Kentuckiana Cancer Institute

A Phase II Study of Radiation With Concomitant and Then Sequential Temozolomide in Patients With Newly Diagnosed Supratentorial Malignant Glioma Who Have Undergone Surgery With Gliadel Wafer Insertion

To determine the safety and efficacy of Gliadel 3.85% wafers plus surgery and radiation with Temozolomide

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

A phase II study of radiation with concomitant and then sequential Temozolomide in patients with newly diagnosed supratentorial malignant glioma who have undergone surgery with Gliadel wafer insertion. To determine the safety and efficacy of Gliadel 3.85% wafers plus surgery and limited field radiation therapy with concomitant Temozolomide followed by Temozolomide alone in patients undergoing initial surgery for newly diagnosed unifocal moderate to high grade glioma.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Kentuckiana Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • MRI showing unilateral supratentorial cerebral tumor
  • surgical tx within 4 weeks of baseline MRI
  • KPS 60% or higher
  • moderate to high grade malignant glioma

Exclusion Criteria:

  • prior cytoreductive surgery for moderate or high grade glioma
  • prior CNS radiotherapy
  • prior chemo for this glioma
  • more than one focus of tumor or tumor crossing the midline per MRI
  • life expectancy less than 12 months
  • sensitivity to temozolomide, nitrosoureas, or Gliadel wafer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To determine the safety and efficacy of Gliadel 3.85% wafers

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kentuckiana Cancer Institute

Collaborators

Eisai Inc.

Investigators

  • Study Director: Renato V. LaRocca, MD, Kentuckiana Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Study Completion (Anticipated)

April 1, 2008

Study Registration Dates

First Submitted

January 26, 2006

First Submitted That Met QC Criteria

January 26, 2006

First Posted (Estimate)

January 30, 2006

Study Record Updates

Last Update Posted (Estimate)

October 31, 2007

Last Update Submitted That Met QC Criteria

October 30, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1068016
  • 128-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Newly Diagnosed Supratentorial Malignant Glioma

Clinical Trials on Temozolomide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe