Spots Global Cancer Trial Database for Cediranib Maleate and Cilengitide in Treating Patients With Progressive or Recurrent Glioblastoma
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Trial Identification
Brief Title: Cediranib Maleate and Cilengitide in Treating Patients With Progressive or Recurrent Glioblastoma
Official Title: A Phase Ib Study of Cediranib in Combination With Cilengitide in Patients With Recurrent Glioblastoma
Study ID: NCT00979862
Study Description
Brief Summary: This phase I trial is studying the side effects and best dose of cediranib maleate when given together with cilengitide in treating patients with progressive or recurrent glioblastoma. Cediranib maleate and cilengitide may stop the growth of tumor cells by blocking blood flow to the tumor. Giving cediranib maleate together with cilengitide may kill more tumor cells.
Detailed Description: PRIMARY OBJECTIVES: I. To determine the safety profile of cediranib (cediranib maleate) in combination with cilengitide in patients with recurrent glioblastoma (Part A). SECONDARY OBJECTIVES: I. To estimate overall survival. II. To estimate the proportion of radiographic responses in recurrent glioblastoma patients with measurable disease treated with cediranib and cilengitide. III. To estimate the proportion of patients alive and progression free at 6 months (APF6) in patients with recurrent glioblastoma treated at the safe dose as determined in Part A (Part B). IV. To explore potential imaging techniques and biomarkers to capture the disease process through treatment. OUTLINE: This is a dose-escalation study of cediranib maleate. Patients are initially enrolled in the dose-finding portion of the study (part A). Once the safe dose of cediranib maleate is determined, additional patients are enrolled in the dose-expansion portion of the study (part B). Part A (dose finding): Patients receive cediranib maleate orally (PO) once daily on days 1-28 and cilengitide intravenously (IV) over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Part B (dose expansion): Patients are assigned to 1 of 2 groups according to prior anti-VEGF therapy (yes vs no). Patients in both groups receive cediranib maleate (administered at the safe dose determined in part A) and cilengitide as in part A. After completion of study therapy, patients are followed up every 2 months.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
Emory University/Winship Cancer Institute, Atlanta, Georgia, United States
Adult Brain Tumor Consortium, Baltimore, Maryland, United States
Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Massachusetts General Hospital, Charlestown, Massachusetts, United States
Henry Ford Hospital, Detroit, Michigan, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States
Contact Details
Name: Elizabeth Gerstner
Affiliation: National Cancer Institute (NCI)
Role: PRINCIPAL_INVESTIGATOR
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