This trial is active, not recruiting.

Condition newly diagnosed supratentorial malignant glioma
Treatments gliadel wafer, temozolomide, limited field radiation
Phase phase 2
Sponsor Kentuckiana Cancer Institute
Collaborator Eisai Inc.
Start date September 2002
End date April 2008
Trial size 40 participants
Trial identifier NCT00283543, 1068016, 128-02


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

To determine the safety and efficacy of Gliadel 3.85% wafers
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 72 years old.

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

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2007.
Information provided to ClinicalTrials.gov by Kentuckiana Cancer Institute.