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
18 Years
72 Years
Both
Newly Diagnosed Supratentorial Malignant Glioma
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To determine the safety and efficacy of Gliadel 3.85% wafers
Principal Investigator
Renato V. LaRocca, MD
Investigator Role:
Study Director
Investigator Affiliation:
Kentuckiana Cancer Institute
Authority:
United States: Institutional Review Board
Study ID:
1068016
NCT ID:
NCT00283543
Start Date:
September 2002
Completion Date:
April 2008
Related Keywords:
- Newly Diagnosed Supratentorial Malignant Glioma
- Glioma
- Gliadel Wafer
- Glioma
Name | Location |
|---|---|
| Kentuckiana Cancer Institute | Louisville, Kentucky 40202 |
