Spots Global Cancer Trial Database for Ramucirumab or Anti-PDGFR Alpha Monoclonal Antibody IMC-3G3 in Treating Patients With Recurrent Glioblastoma Multiforme
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Trial Identification
Brief Title: Ramucirumab or Anti-PDGFR Alpha Monoclonal Antibody IMC-3G3 in Treating Patients With Recurrent Glioblastoma Multiforme
Official Title: An Open Label, Phase 2 Study Evaluating the Safety and Efficacy of IMC-3G3 or IMC-1121B in Patients With Recurrent Glioblastoma Multiforme
Study ID: NCT00895180
Conditions
Study Description
Brief Summary: RATIONALE: Monoclonal antibodies, such as ramucirumab and anti-PDGFR alpha monoclonal antibody IMC-3G3 (Olaratumab), can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. PURPOSE: This phase II trial is studying how well ramucirumab or anti-PDGFR alpha monoclonal antibody IMC-3G3 works in treating patients with recurrent glioblastoma multiforme.
Detailed Description: OBJECTIVES: Primary * To assess the progression-free survival rate at 6 months after treatment with ramucirumab or anti-PDGFR alpha monoclonal antibody IMC-3G3 in patients with recurrent glioblastoma multiforme. Secondary * To evaluate the acute and late toxicities associated with these regimens. * To assess the objective tumor response rate. * To estimate the overall survival of these patients. * To describe the pharmacokinetic and pharmacodynamic profiles and immunogenicity of these regimens. OUTLINE: This is a multicenter study. Patients are sequentially assigned to 1 of 2 treatment groups. * Group 1: Patients receive ramucirumab IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. * Group 2: Patients receive anti-PDGFR alpha monoclonal antibody IMC-3G3 IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UAB Comprehensive Cancer Center, Birmingham, Alabama, United States
Jonsson Comprehensive Cancer Center at UCLA, Los Angeles, California, United States
University of California San Francisco Medical Center, San Francisco, California, United States
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida, Tampa, Florida, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Josephine Ford Cancer Center at Henry Ford Hospital, Detroit, Michigan, United States
Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center, Madison, Wisconsin, United States
Contact Details
Name: Jaishri O. Blakeley, MD
Affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Role: STUDY_CHAIR
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