Clinical Trial Finder

DISEASE CHARACTERISTICS:

• - Newly diagnosed grade III or IV glioma including any of the following: - Glioblastoma.

• - Anaplastic astrocytoma.

• - Gliosarcoma.

• - Anaplastic oligodendroglioma.

• - Anaplastic oligoastrocytoma.

• - Measurable or nonmeasurable disease.

• - No more than 5 weeks since prior brain surgery.

• - Recovered from surgery, post- operative infection, and other complications.

• - Preoperatively and postoperatively diagnostic contrast-enhanced MRI or CT scan of the brain performed prior to radiation therapy.

• - Patients diagnosed by stereotactic biopsy do not require the postoperative scan.

PATIENT CHARACTERISTICS:

• - Karnofsky performance status ≥ 60% - Absolute neutrophil count ≥ 1,500/mm^3.

• - Platelet count ≥ 100,000/mm^3.

• - Serum creatinine ≤ 1.5 times upper limit of normal (ULN) - Total bilirubin ≤ 2.0 mg/dL.

• - AST ≤ 4.0 times ULN.

• - No prolonged QT interval > 460 milliseconds on baseline electrocardiogram in the presence of normal serum potassium and magnesium.

• - No uncontrolled electrolyte imbalance (i.e., sodium < 132 mmol/L, potassium < 3.5 mEq/dL, magnesium < 1.7 mg/dL) - No history of torsades de pointes type of ventricular arrhythmia.

• - Negative pregnancy test.

• - Not pregnant or nursing.

• - Fertile patients must use effective contraception.

• - No medical or psychiatric illness that, in the investigator's opinion, could potentially preclude the completion of study therapy.

• - No HIV positivity.

• - No active connective tissue disorders (e.g., lupus or scleroderma) that, in the investigator's opinion, may put the patient at high risk for radiation toxicity.

PRIOR CONCURRENT THERAPY:

• - See Disease Characteristics.

• - No prior brain radiotherapy or chemotherapy for brain tumor.

• - Concurrent corticosteroids to control cerebral edema allowed provided dose is stable or decreasing for the past 5 days.

• - No concurrent or plan to receive drugs that are known to prolong the QT interval.

- No prior radiation to the head or neck (except for T1 glottic cancer) resulting in overlap of radiation fields

OBJECTIVES:

• - Determine the maximum tolerated dose of arsenic trioxide when administered sequentially with temozolomide during radiotherapy in patients with newly diagnosed glioblastoma multiforme.

• - Determine the dose-limiting toxicities of this regimen in these patients.

OUTLINE: This is a dose-escalation study of arsenic trioxide. Patients undergo radiotherapy (may be intensity-modulated) on days 1-5. Patients also receive arsenic trioxide IV over 1-2 hours on days 1-5, and oral temozolomide on days 1-7. Treatment with radiotherapy, arsenic trioxide, and temozolomide repeats every week for up to 6 weeks in the absence of disease progression or unacceptable toxicity. Patients may then receive oral temozolomide on days 1-5. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression. After completion of study therapy, patients are followed periodically.