Radiation With Concomitant and Then Sequential Temozolomide in Malignant Glioma
Phase 2
- Conditions
- Newly Diagnosed Supratentorial Malignant Glioma
- Registration Number
- NCT00283543
- Lead Sponsor
- Kentuckiana Cancer Institute
- Brief Summary
To determine the safety and efficacy of Gliadel 3.85% wafers plus surgery and radiation with Temozolomide
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To determine the safety and efficacy of Gliadel 3.85% wafers
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Kentuckiana Cancer Institute
🇺🇸Louisville, Kentucky, United States