Last updated on November 2018

ERC1671/GM-CSF/Cyclophosphamide for the Treatment of Glioblastoma Multiforme


Brief description of study

This phase II clinical trial studies how well ERC1671 plus Granulocyte-macrophage colony-stimulating factor (GM-CSF) plus Cyclophosphamide with Bevacizumab works compared to Placebo Injection plus Placebo Pill with Bevacizumab in treating patients with recurrent/progressive, bevacizumab nave glioblastoma multiforme and gliosarcoma (World Health Organization (WHO) grade IV malignant gliomas, GBM).

Detailed Study Description

PRIMARY OBJECTIVES:

The primary objective of the study is to determine the 6-month progression free survival probability of patients with recurrent, bevacizumab nave glioblastoma multiforme treated with ERC1671 in combination with GM-CSF and cyclophosphamide plus bevacizumab as compared with patients receiving bevacizumab plus placebo controls.

SECONDARY OBJECTIVES:

  1. To evaluate radiographic response, progression free survival and overall survival of patients with recurrent malignant glioma treated with the ERC1671 regimen plus bevacizumab
  2. To evaluate safety and tolerability of ERC1671 plus bevacizumab among patients with recurrent glioblastoma.
  3. To characterize of the immune response to ERC1671 vaccination in adult patients with relapsed glioblastoma. The patient's immune response evaluation will include cytotoxic T lymphocytes (CTL) (cluster of differentiation 3+ (CD3+)/cluster of differentiation 8+ (CD8)+) and Treg (cluster of differentiation 3+/cluster of differentiation 4+ (CD4+)/cluster of differentiation 25+ )CD25+/cluster of differentiation 127low (CD127low)) populations. Cytokine analyses should initially be limited to interferon (IFN)-, tumor necrosis factor (TNF) and interleukin (IL)-6). Further immune studies should include TGF-B2, IL-12, IL-10.

If this study demonstrates that the combination regimen of ERC1671 in combination with bevacizumab is associated with encouraging anti-tumor activity among patients with recurrent glioblastoma multiforme, further assessment of this regimen in a phase III study will be considered.

OUTLINE: This is a blinded Phase II study of ERC1671 in combination with bevacizumab in patients with relapsed, bevacizumab naive glioblastoma. The patients who will be randomized (in a 1:1 ratio) to receive either ERC 1671 in combination with GM-CSF and cyclophosphamide or a placebo control, in combination with bevacizumab. The study will be double blinded.

ERC1671/GM-CSF will be intradermally administered, while cyclophosphamide is orally administered. GM-CSF dose is 250 g/m and cyclophosphamide dose is 50 mg/day. Bevacizumab is administered as standard of care at 10 mg/kg.

The treatment cycles will be 28 days long.

Clinical Study Identifier: NCT01903330

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Recruitment Status: Open


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