Radiation With Concomitant and Then Sequential Temozolomide in Malignant Glioma

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 radiation with Temozolomide

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.

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