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A Phase I/II Trial of EMD 121974 for Treatment of Patients With Recurrent Anaplastic Gliomas
RATIONALE: EMD 121974 may stop the growth of cancer by stopping blood flow to the tumor. PURPOSE: Phase I/II trial to study the effectiveness of EMD 121974 in treating patients who have progressive or recurrent malignant glioma.
OBJECTIVES: * Determine the maximum tolerated dose and dose-limiting toxicity of EMD 121974 in patients with progressive or recurrent malignant glioma. * Determine the 6-month progression-free survival, clinical response rate, duration of progression-free survival, and overall survival in patients treated with this drug. * Determine the effects of this drug on tumor perfusion, measured with magnetic resonance perfusion scan, and markers for angiogenesis in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients receive EMD 121974 IV over 1 hour twice weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 6-12 patients receive escalating doses of EMD 121974 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which more than 2 of 6 or 4 of 12 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at the MTD. Patients are followed every 2 months. PROJECTED ACCRUAL: A minimum of 6 patients will be accrued for phase I of this study within 2-3 months. A total of 23-38 patients will be accrued for phase II of this study within 5-10 months.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Emory University Hospital - Atlanta
Atlanta, Georgia, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Start Date
September 1, 2000
Completion Date
October 1, 2006
Last Updated
June 24, 2013
cilengitide
DRUG
Lead Sponsor
New Approaches to Brain Tumor Therapy Consortium
Collaborators
NCT00602667
NCT00683319
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07416188