Adult Glioblastoma Multiforme Clinical Trial
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
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.
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.
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