Patient case: 82-year-old male with glioma; genetic feature: BRAF

Clinical trial: Temozolomide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Anaplastic Oligodendrogliomas or Mixed Anaplastic Oligoastrocytomas

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.

Detailed description: 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: 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

Relevance to patient case: not relevant