Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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
Eisai Inc.
Information provided by:
Kentuckiana Cancer Institute Identifier:
First received: January 26, 2006
Last updated: October 30, 2007
Last verified: October 2007
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: 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.

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00283543

United States, Kentucky
Kentuckiana Cancer Institute
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
Kentuckiana Cancer Institute
Eisai Inc.
Study Director: Renato V. LaRocca, MD Kentuckiana Cancer Institute
  More Information Identifier: NCT00283543     History of Changes
Other Study ID Numbers: 1068016
Study First Received: January 26, 2006
Last Updated: October 30, 2007

Keywords provided by Kentuckiana Cancer Institute:
Gliadel Wafer

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents processed this record on May 25, 2017