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Radiation With Concomitant and Then Sequential Temozolomide in Malignant Glioma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Kentuckiana Cancer Institute.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Eisai Inc.
Information provided by:
Kentuckiana Cancer Institute
ClinicalTrials.gov Identifier:
NCT00283543
First received: January 26, 2006
Last updated: October 30, 2007
Last verified: October 2007
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 72 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00283543     History of Changes
Other Study ID Numbers: 1068016, 128-02
Study First Received: January 26, 2006
Last Updated: October 30, 2007
Health Authority: United States: Institutional Review Board

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
Carmustine
 Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013