NCT01903330

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

A Randomized, Double-blinded, Placebo-controlled Study of (ERC1671/GM-CSF/Cyclophosphamide)+Bevacizumab vs. (Placebo Injection/Placebo Pill) +Bevacizumab in the Treatment of Recurrent/Progressive, Bevacizumab naïve Glioblastoma Multiforme and Glioasarcoma Patients (WHO Grade IV Malignant Gliomas, GBM)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Epitopoietic Research Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 naïve glioblastoma multiforme and gliosarcoma (World Health Organization (WHO) grade IV malignant gliomas, GBM).

Detailed description

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 500mcg fixed dose and cyclophosphamide dose is 50 mg/day. Bevacizumab or approved bevacizumab biosimilars are administered as standard of care at 10 mg/kg every 2 weeks. The treatment cycles will be 28 days long.

Conditions

• Glioblastoma
• Gliosarcoma

Interventions

Type	Name	Description
DRUG	ERC1671	Given intradermally
DRUG	GM-CSF	Given intradermally
DRUG	Cyclophosphamide	Given PO. Drug class: Alkylating Agent; Antineoplastic Agent; Nitrogen Mustard.
DRUG	Oral Control (Sucrose pill)	Given PO
DRUG	Injectable control (Sodium Chloride Injection United States Pharmacopeia (USP) (0.9%))	Given IV
DRUG	Bevacizumab/Bevacizumab Biosimilar	Given IV. Drug class: Immunological Agent; Monoclonal Antibody.

Timeline

• Start date: 2014-03-01
• Primary completion: 2026-03-01
• Completion: 2026-06-01
• First posted: 2013-07-19
• Last updated: 2025-03-05

Locations

3 sites across 1 country: United States