Clinical Trial Finder

DISEASE CHARACTERISTICS:

• - Histologically confirmed intracranial malignant glioma, including glioblastoma multiforme, gliosarcoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, or malignant astrocytoma not otherwise specified.

• - Unequivocal evidence of relapsed or refractory disease by MRI or CT scan and/or tumor resection.

• - Steroid therapy prior to MRI or CT scan must have been at a stable dose for at least 5 days.

• - Failed prior radiotherapy.

• - Must have confirmation of true progression rather than radiation necrosis if previously treated with interstitial brachytherapy or stereotactic radiosurgery.

PATIENT CHARACTERISTICS: Age.

• - 18 and over.

Performance status.

• - Karnofsky 60-100% Life expectancy.

• - More than 2 months.

Hematopoietic.

• - Absolute neutrophil count at least 1,500/mm3.

• - Platelet count at least 100,000/mm3.

• - Hemoglobin greater than 9 g/dL.

• - No history of bleeding disorder.

Hepatic.

• - Bilirubin less than 1.5 mg/dL.

• - SGPT less than 2.5 times normal.

• - Alkaline phosphatase less than 2.5 times normal.

Renal.

• - Creatinine less than 1.5 times upper limit of normal (ULN) OR.

• - BUN less than 1.5 times ULN.

Cardiovascular.

• - No deep vein thrombosis within the past 3 weeks (must be clinically stable) Pulmonary.

• - No pulmonary embolism within the past 3 weeks (must be clinically stable) Other.

• - No peripheral neuropathy grade 2 or greater.

• - No active infection.

• - No other serious concurrent medical illness.

• - No concurrent illness that may obscure toxicity or dangerously alter drug metabolism.

• - No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix.

• - Must participate in the System for Thalidomide Education and Prescribing Safety program.

• - Not pregnant or nursing.

• - Negative pregnancy test.

• - Fertile patients must use 2 forms of effective contraception for 1 month before, during, and for 1 month after study.

PRIOR CONCURRENT THERAPY: Biologic therapy.

• - No prior oral thalidomide or celecoxib for more than 2 months duration.

Chemotherapy.

• - No prior oral etoposide or cyclophosphamide for more than 2 months duration.

• - Prior standard-dose IV etoposide and cyclophosphamide allowed.

Endocrine therapy.

• - See Disease Characteristics.

• - Concurrent steroids allowed.

Radiotherapy.

• - See Disease Characteristics.

• - At least 4 weeks since prior radiotherapy.

Surgery.

• - See Disease Characteristics.

• - Prior surgery for relapsed or refractory disease allowed.

• - Recovered from prior surgery.

• - No concurrent surgery.

Other.

• - No other concurrent investigational agents or treatment.

• - No other concurrent anticancer therapy.

- Concurrent antiseizure medications allowed

OBJECTIVES:

• - Determine the efficacy of thalidomide, celecoxib, etoposide, and cyclophosphamide, in terms of 6-month progression-free survival, in patients with relapsed or refractory malignant glioma.

• - Determine the overall survival of patients treated with this regimen.

• - Determine the toxic effects of this regimen in these patients.

• - Determine the radiographic response in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients receive oral thalidomide once daily and oral celecoxib twice daily on days 1-42, oral etoposide once daily on days 1-21, and oral cyclophosphamide once daily on days 22-42. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months. PROJECTED ACCRUAL: A total of 48 patients (32 with glioblastoma multiforme and 16 with anaplastic glioma) will be accrued for this study within 2 years.