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

Part of paid clinical trials in Orange, California.

Sponsor
Epitopoietic Research Corporation
Study ID
NCT01903330
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

First listed
Jul 19, 2013
Start date
Mar 31, 2014
Status verified
May 2022
Primary completion
Mar 31, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
84 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: (ERC1671/GM-CSF/Cyclophosphamide)+bevacizumab/bevacizumab biosimilar
    ERC1671 and 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 will be repeated every 28 days until progression of disease or intolerance.
  • Placebo Comparator: (Placebo Injection/Placebo Pill) +Bevacizumab/bevacizumab biosimilar
    The control group will have the same study schedule except that the patients will be receiving the Oral Control on the Cyclophosphamide treatment days and the Injectable control on the GM-CSF + ERC1671 treatment days. The control group will receive bevacizumab or approved bevacizumab biosimilar just as the active treatment group above. The treatment will be repeated every 28 days until progression of disease or intolerance.

Primary Outcome Measure

Overall Survival at 12 months of patients with recurrent, bevacizumab naïve glioblastoma treated with ERC1671 in combination with GM-CSF and cyclophosphamide plus bevacizumab as compared with patients receiving bevacizumab plus placebo controls. [ Time Frame: 12 months ]

Locations (3)

FacilityCityStateZIPSite coordinators
University of California, IrvineOrangeCalifornia92868-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114-

Find similar trials in Orange, CA

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
University of California, Irvine· Orange, CADana Farber Cancer Institute· Boston, MAMassachusetts General Hospital Cancer Center· Boston, MA

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