Brain and Central Nervous System Tumors
Conditions
Keywords
recurrent adult brain tumor, adult glioblastoma, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult giant cell glioblastoma, adult gliosarcoma
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of atrasentan in treating patients who have progressive or recurrent malignant glioma.
Detailed description
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.
Interventions
Sponsors
National Cancer Institute (NCI)
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Countries
United States
Outcome results
None listed