Temozolomide and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Anaplastic Astrocytoma
Temozolomide and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Anaplastic Astrocytoma
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 uses high-energy x-rays to kill tumor cells. Specialized radiation therapy
 that delivers a high dose of radiation directly to the tumor may kill more tumor cells and
 cause less damage to normal tissue. Giving chemotherapy together with radiation therapy may
 kill more tumor cells.

 PURPOSE: This phase I trial is studying the side effects and best dose of temozolomide when
 given together with radiation therapy in treating patients with newly diagnosed glioblastoma
 multiforme or anaplastic astrocytoma.
OBJECTIVES:

 Primary

 -  To determine the maximum tolerated dose of temozolomide when given in combination with
 hypofractionated intensity-modulated conformal stereotactic radiotherapy in patients
 with newly diagnosed de novo glioblastoma multiforme or anaplastic astrocytoma.

 Secondary

 -  To determine the time to neuroradiological evidence of tumor recurrence or progression
 in patients treated with this regimen.

 -  To determine the survival time of patients treated with this regimen.

 -  To determine the time spent in a Karnofsky performance status of 60-100%.

 OUTLINE: This is a dose-escalation study of temozolomide.

 Beginning 1-3 weeks following surgery or biopsy, patients receive oral temozolomide once
 daily for 5 weeks. Beginning 1 week after starting temozolomide, patients also undergo
 hypofractionated intensity-modulated conformal stereotactic radiotherapy once daily 5 days a
 week for 3 weeks.

 After completion of study treatment, patients are followed at 1 month, 2 months, and 3
 months, and then every 3 months thereafter.
Inclusion Criteria:

 -  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 Criteria:

 -  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.