Temozolomide and Radiation Therapy With or Without Vatalanib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

DISEASE CHARACTERISTICS:

• Histologically confirmed glioblastoma multiforme

  • Newly diagnosed disease
• Deemed to be amenable to concurrent and adjuvant temozolomide treatment by the principal investigator

PATIENT CHARACTERISTICS:

Age

• 18 to 69

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3

Hepatic

• Bilirubin < 1.5 times upper limit of normal (ULN)
• Alkaline phosphatase < 2.5 times ULN
• ALT and AST < 2.5 times ULN

Renal

• Creatinine ≤ 1.7 mg/dL

Cardiovascular

• Cardiac function clinically normal
• 12-lead ECG normal
• No ischemic heart disease within the past 6 months
• No uncontrolled cardiac arrhythmia
• No uncontrolled hypertension
• No history of stroke
• No history of congenital long QT syndrome
• QTc interval ≤ 450 msec for males or ≤ 470 msec for females by 12-lead ECG

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other malignancy except adequately treated basal cell or squamous cell skin cancer or cone biopsied carcinoma in situ of the cervix
• No active uncontrolled infection
• No other unstable systemic disease
• No psychological, familial, sociological, or geographical condition that would preclude study compliance or follow-up schedule

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior anti-vascular endothelial growth factor therapy

Chemotherapy

• No prior chemotherapy

Endocrine therapy

• Concurrent corticosteroids allowed provided the patient is on stable or decreasing doses for ≥ 2 weeks before study entry

Radiotherapy

• No prior radiotherapy

Surgery

• More than 8 days, but < 6 weeks, since prior surgery or biopsy

Other

• No prior randomization on this study
• No concurrent warfarin, warfarin-derived drugs, or similar anticoagulants
• No other concurrent anticancer therapy
• No other concurrent investigational agents

• No concurrent enzyme inducing antiepileptic drugs, including any of the following:

  • Carbamazepine
  • Fosphenytoin
  • Oxcarbazepine
  • Phenobarbital
  • Phenytoin
  • Primidone
• No concurrent grapefruit or grapefruit juice