Atrasentan in Treating Patients With Progressive or Recurrent Malignant Glioma

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Completed

CT.gov ID

NCT00017264

Collaborator

(none)

Locations

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brain and Central Nervous System Tumors	Drug: atrasentan hydrochloride	Phase 1

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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2002

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama	United States	35294-3300
2	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida	United States	33612-9497
3	Winship Cancer Institute of Emory University	Atlanta	Georgia	United States	30322
4	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland	United States	21231-2410
5	Massachusetts General Hospital Cancer Center	Boston	Massachusetts	United States	02114
6	Josephine Ford Cancer Center at Henry Ford Hospital	Detroit	Michigan	United States	48202
7	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina	United States	27157-1082
8	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio	United States	44195
9	Abramson Cancer Center at University of Pennsylvania Medical Center	Philadelphia	Pennsylvania	United States	19104
10	University of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78284-7811