Status:
UNKNOWN
Radiation With Concomitant and Then Sequential Temozolomide in Malignant Glioma
Lead Sponsor:
Kentuckiana Cancer Institute
Collaborating Sponsors:
Eisai Inc.
Conditions:
Newly Diagnosed Supratentorial Malignant Glioma
Eligibility:
All Genders
18-72 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00283543
Start Date
September 1 2002
End Date
April 1 2008
Last Update
October 31 2007
Active Locations (1)
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1
Kentuckiana Cancer Institute
Louisville, Kentucky, United States, 40202