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

NCT01903330 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2025-03-05

No results posted yet for this study

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).

Conditions

Interventions

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.

Sponsors & Collaborators

  • University of California, Irvine

    collaborator OTHER

  • Epitopoietic Research Corporation

    lead INDUSTRY

Principal Investigators

  • Daniela A. Bota, MD, PhD · University of California, Irvine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2026-03-31
Completion
2026-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01903330 on ClinicalTrials.gov