Atrasentan in Treating Patients With Progressive or Recurrent Malignant Glioma

Study Overview
=================
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.

Official Title
-----------------
A Phase I Evaluation of the Safety and Pharmacokinetics of ABT-627 in Adults With Recurrent Malignant Gliomas

Conditions
-----------------
Brain and Central Nervous System Tumors

Intervention / Treatment
-----------------
* Drug: atrasentan hydrochloride


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: atrasentan hydrochloride|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
recurrent adult brain tumor, adult glioblastoma, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult giant cell glioblastoma, adult gliosarcoma