Spots Global Cancer Trial Database for EMD 121974 in Treating Patients With Progressive or Recurrent Glioma
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Trial Identification
Brief Title: EMD 121974 in Treating Patients With Progressive or Recurrent Glioma
Official Title: A Phase I/II Trial of EMD 121974 for Treatment of Patients With Recurrent Anaplastic Gliomas
Study ID: NCT00006093
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Contact Details
Name: Louis B. Nabors, MD
Affiliation: University of Alabama at Birmingham
Role: STUDY_CHAIR
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