Status:
COMPLETED
Temozolomide and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Anaplastic Astrocytoma
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Conditions:
Glioblastoma Multiforme/Anaplastic Astrocytoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy ...
Detailed Description
OBJECTIVES: Primary * To determine the maximum tolerated dose of temozolomide when given in combination with hypofractionated intensity-modulated conformal stereotactic radiotherapy in patients with...
Eligibility Criteria
Inclusion
- Patients who have De novo glioblastoma multiforme, anaplastic astrocytoma, anaplastic oligodendrogliomas, mixed anaplastic oligoastrocytomas, gliosarcoma of the Brain, not involving the brain stem or optics chiasm, diagnosed following biopsy or tumor removal.
- Age \> 18 years
- Given written consent
- Adequate bone marrow reserve(hemoglobin \> 10 grams, Absolute neutrophil count \> 1500 / mm3, platelets \> 100,000/ mm3)
- Normal renal function(BUN \< 24 mg/dL, Creatinine \< 1.3 mg/dL)
- Normal liver function(Total Bilirubin \< 1.5 mg/dL, SGPT/ALT \< 60 U/L)
Exclusion
- Have a Karnofsky score of \< 60 \[Appendix B\] or age \< 18 years.
- Prior chemotherapy and/or radiotherapy of their glioblastomamultiforme, anaplastic astrocytoma, anaplastic oligodendrogliomas, mixed anaplastic oligoastrocytomas, gliosarcoma.
- Tumors located in the brainstem or optic chiasm.
- Prior radiation therapy to the brain
- Prior chemotherapy within the past 6 weeks.
Key Trial Info
Start Date :
February 13 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 25 2014
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00841555
Start Date
February 13 2009
End Date
November 25 2014
Last Update
April 18 2018
Active Locations (1)
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1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210