temozolomide plus radiation therapy in treating patients with newly diagnosed anaplastic oligodendrogliomas or mixed anaplastic oligoastrocytomas

Conditions: Brain and Central Nervous System Tumors

Summary: 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.

Eligibility criteria:
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

Keywords: adult anaplastic oligodendroglioma adult mixed glioma