Radiation With Concomitant and Then Sequential Temozolomide in Malignant Glioma

• Status: Unknown status
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kentuckiana Cancer Institute
• Collaborator: Eisai Inc.
• Treatments: Carmustine; Dacarbazine; Temozolomide

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