Temozolomide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Anaplastic Oligodendrogliomas or Mixed Anaplastic Oligoastrocytomas
Temozolomide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Anaplastic Oligodendrogliomas or Mixed Anaplastic Oligoastrocytomas
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
 they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.
 Combining chemotherapy and radiation therapy may kill more tumor cells.

 PURPOSE: Phase II trial to study the effectiveness of combining temozolomide with radiation
 therapy in treating patients who have newly diagnosed anaplastic oligodendrogliomas or mixed
 anaplastic oligoastrocytomas.
OBJECTIVES:

 -  Determine the rate of progression in patients with newly diagnosed anaplastic
 oligodendrogliomas or mixed anaplastic oligoastrocytomas treated with neoadjuvant and
 concurrent temozolomide with radiotherapy.

 -  Determine the toxicity of this regimen in these patients.

 -  Determine the survival of patients treated with this regimen.

 OUTLINE: This is a multicenter study. Patients are stratified according to response to
 neoadjuvant temozolomide (stable disease or partial response (PR) vs complete response (CR)).

 Patients receive oral temozolomide on days 1-7 and 15-21. Treatment repeats every 28 days for
 up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with
 CR or PR receive 2 courses beyond CR or PR.

 Within 6 weeks after completion of neoadjuvant temozolomide, patients with stable disease or
 PR undergo radiotherapy 5 days a week for 6.5 weeks. Patients also receive oral temozolomide
 daily for 42 days concurrently with radiotherapy.

 Patients with CR after completion of neoadjuvant temozolomide undergo observation.

 Patients are followed at 9 and 12 months, every 4 months for 1 year, every 6 months for 3
 years, and then annually thereafter.

 PROJECTED ACCRUAL: A maximum of 37 patients will be accrued for this study within 12 months.
DISEASE CHARACTERISTICS:

 -  Histologically or cytologically confirmed supratentorial pure or mixed anaplastic
 oligodendroglioma

 -  Unifocal or multifocal disease

 -  Prior suspected or proven low-grade glioma eligible provided biopsy reveals pure
 or mixed anaplastic oligodendroglioma that has not been previously treated with
 radiotherapy and/or chemotherapy

 -  No equivocal oligodendroglial element

 -  No tumors predominantly located in the posterior fossa (i.e., brainstem or cerebellum)

 -  No spinal cord tumors

 -  No evidence of spinal drop metastasis or spread to noncontiguous meninges

 PATIENT CHARACTERISTICS:

 Age:

 -  18 to 65

 Performance status:

 -  Zubrod 0-1

 Life expectancy:

 -  More than 12 weeks

 Hematopoietic:

 -  Absolute granulocyte count at least 1,500/mm^3

 -  Platelet count at least 100,000/mm^3

 -  Hemoglobin at least 10 g/dL

 Hepatic:

 -  Bilirubin no greater than 2 times normal

 -  Aspartate aminotransferase (AST) no greater than 3 times normal

 -  Alkaline phosphatase no greater than 2 times normal

 Renal:

 -  Creatinine no greater than 1.5 times normal

 Other:

 -  No active infection

 -  No other medical problems that would preclude study participation

 -  No other malignancy within the past 3 years except carcinoma in situ of the cervix or
 nonmelanoma skin cancer

 -  Not pregnant or nursing

 -  Negative pregnancy test

 -  Fertile patients must use effective contraception

 PRIOR CONCURRENT THERAPY:

 Biologic therapy:

 -  Not specified

 Chemotherapy:

 -  See Disease Characteristics

 -  No prior chemotherapy for this malignancy

 -  No prior temozolomide

 Endocrine therapy:

 -  Not specified

 Radiotherapy:

 -  See Disease Characteristics

 -  No prior radiotherapy to the brain, head, or neck

 Surgery:

 -  At least 14 days since prior surgery requiring general anesthesia