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Radiation With Concomitant and Then Sequential Temozolomide in Malignant Glioma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2007 by Kentuckiana Cancer Institute.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00283543
First Posted: January 30, 2006
Last Update Posted: October 31, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Eisai Inc.
Information provided by:
Kentuckiana Cancer Institute
  Purpose
To determine the safety and efficacy of Gliadel 3.85% wafers plus surgery and radiation with Temozolomide

Condition Intervention Phase
Newly Diagnosed Supratentorial Malignant Glioma Drug: Gliadel Wafer Drug: Temozolomide Procedure: Limited field radiation Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Kentuckiana Cancer Institute:

Primary Outcome Measures:
  • To determine the safety and efficacy of Gliadel 3.85% wafers

Estimated Enrollment: 40
Study Start Date: September 2002
Estimated Study Completion Date: April 2008
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 72 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00283543


Locations
United States, Kentucky
Kentuckiana Cancer Institute
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
Kentuckiana Cancer Institute
Eisai Inc.
Investigators
Study Director: Renato V. LaRocca, MD Kentuckiana Cancer Institute
  More Information

ClinicalTrials.gov Identifier: NCT00283543     History of Changes
Other Study ID Numbers: 1068016
128-02
First Submitted: January 26, 2006
First Posted: January 30, 2006
Last Update Posted: October 31, 2007
Last Verified: October 2007

Keywords provided by Kentuckiana Cancer Institute:
Glioma
Gliadel Wafer

Additional relevant MeSH terms:
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Dacarbazine
Carmustine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents