Atrasentan in Treating Patients With Progressive or Recurrent Malignant Glioma

National Cancer Institute (NCI)

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Brain and Central Nervous System Tumors

Interventions

atrasentan hydrochlorideDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (10)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, United States

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Winship Cancer Institute of Emory University

Atlanta, Georgia, United States

Data from ClinicalTrials.gov

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