Atrasentan in Treating Patients With Progressive or Recurrent Malignant Glioma
|ClinicalTrials.gov Identifier: NCT00017264|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 13, 2009
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|
- 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 (Clinical Trial)|
|Official Title:||A Phase I Evaluation of the Safety and Pharmacokinetics of ABT-627 in Adults With Recurrent Malignant Gliomas|
|Study Start Date :||June 2002|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00017264
|United States, Alabama|
|University of Alabama at Birmingham Comprehensive Cancer Center|
|Birmingham, Alabama, United States, 35294-3300|
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612-9497|
|United States, Georgia|
|Winship Cancer Institute of Emory University|
|Atlanta, Georgia, United States, 30322|
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|United States, Massachusetts|
|Massachusetts General Hospital Cancer Center|
|Boston, Massachusetts, United States, 02114|
|United States, Michigan|
|Josephine Ford Cancer Center at Henry Ford Hospital|
|Detroit, Michigan, United States, 48202|
|United States, North Carolina|
|Comprehensive Cancer Center at Wake Forest University|
|Winston-Salem, North Carolina, United States, 27157-1082|
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Center|
|Cleveland, Ohio, United States, 44195|
|United States, Pennsylvania|
|Abramson Cancer Center at University of Pennsylvania Medical Center|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Texas|
|University of Texas Health Science Center at San Antonio|
|San Antonio, Texas, United States, 78284-7811|
|Study Chair:||Surasak Phuphanich, MD, FAAN||Emory University|