Ensayos clínicos

DISEASE CHARACTERISTICS:

• Histologically confirmed diagnosis of 1 of the following:
  • Anaplastic oligodendroglioma
  • Anaplastic oligoastrocytoma
  • Anaplastic astrocytoma
• Newly diagnosed disease
• Prior surgery for a low grade tumor is allowed, provided histological confirmation of an anaplastic tumor is present at the time of progression
• Absence of combined 1p/19q loss
• Tumor material available for central 1p/19q assessment, central O6-methylguanine-DNA methyltransferase promoter methylation status assessment, isocitrate dehydrogenase mutation analysis, and central pathology review
• Patients must be on a stable or decreasing dose of steroids for at least two weeks prior to randomization

PATIENT CHARACTERISTICS:

• WHO performance status 0-2
• ANC ≥ 1.5 x 10^9 cells/L
• Platelet count ≥ 100 x 10^9 cells/L
• Bilirubin < 1.5 x upper limit of normal (ULN)
• Alkaline phosphatase < 2.5 x ULN
• AST and ALT < 2.5 x ULN
• Serum creatinine < 1.5 x ULN
• Not pregnant or nursing
• Fertile patients must use effective contraception
• No known HIV infection or chronic hepatitis B or hepatitis C infection
• No other serious medical condition that would interfere with follow-up
• No medical condition that could interfere with oral medication intake (e.g., frequent vomiting or partial bowel obstruction)
• No other prior malignancies except for any malignancy which was treated with curative intent more than 5 years prior to registration and adequately controlled limited basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix
• No prior or concurrent malignancies at other sites except for surgically cured carcinoma in situ of the cervix or nonmelanoma skin cancer
• No psychological, familial, sociological, or geographical condition that would potentially hamper compliance with the study protocol and follow-up schedule

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No prior chemotherapy, including carmustine-containing wafers (Gliadel®)
• No prior radiotherapy to the brain
• No concurrent growth factors unless vital for the patient
• No other concurrent investigational treatment
• No other concurrent anticancer agents