Clinical Trial Finder

DISEASE CHARACTERISTICS:

• - Histologically confirmed malignant glioma.

• - Anaplastic astrocytoma.

• - Anaplastic oligodendroglioma.

• - Glioblastoma multiforme.

• - Progressive or recurrent after prior radiotherapy with or without chemotherapy.

• - Prior low-grade glioma that has progressed to high-grade after therapy allowed.

• - Measurable disease by MRI or CT scan.

PATIENT CHARACTERISTICS: Age:

• - 18 and over.

Performance status:

• - Karnofsky 60-100% Life expectancy: - Not specified.

Hematopoietic:

• - Absolute neutrophil count at least 1,500/mm^3.

• - Platelet count at least 100,000/mm^3.

Hepatic:

• - Bilirubin no greater than 1.5 mg/dL.

• - Transaminases no greater than 4 times upper limit of normal.

• - Hepatitis A, B, and C negative.

Renal:

• - Creatinine no greater than 1.7 mg/dL.

Cardiovascular:

• - No New York Heart Association class II, III, or IV cardiac disease.

Other:

• - HIV negative.

• - Mini mental score at least 15.

• - No other malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell skin cancer.

• - No serious concurrent infection.

• - No other concurrent medical illness that would preclude study entry.

• - No alcoholism or drug addiction within the past 6 months.

• - Not pregnant or nursing.

• - Negative pregnancy test.

• - Fertile patients must use effective contraception.

PRIOR CONCURRENT THERAPY: Biologic therapy:

• - No concurrent anticancer immunotherapy.

Chemotherapy:

• - See Disease Characteristics.

• - At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered.

• - No more than 1 prior chemotherapy regimen.

• - No prior or concurrent polifeprosan 20 with carmustine implant (Gliadel wafer) - No prior atrasentan.

• - No other concurrent anticancer chemotherapy.

Endocrine therapy:

• - No concurrent anticancer hormonal therapy.

Radiotherapy:

• - See Disease Characteristics.

• - At least 3 months since prior radiotherapy and recovered.

• - No concurrent anticancer radiotherapy.

Surgery:

• - No concurrent anticancer surgery.

Other:

• - Recovered from prior therapy.

• - No more than 1 prior treatment regimen.

- No other concurrent investigational agents

OBJECTIVES:

• - Determine the maximum tolerated dose of atrasentan in patients with progressive or recurrent malignant glioma.

• - Describe the pharmacokinetics of this drug in these patients.

• - Assess preliminary evidence of therapeutic activity of this drug in these patients.

OUTLINE: This is a dose-escalation, multicenter study. Patients receive oral atrasentan once daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 2-10 patients receive escalating doses of atrasentan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 1 patient experiences dose-limiting toxicity. Patients are followed every 2 months. PROJECTED ACCRUAL: Approximately 35 patients will be accrued for this study.