Study on ERC1671, GM-CSF, and Cyclophosphamide for Treating Glioblastoma Multiforme

Sponsor: Epitopoietic Research Corporation

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT01903330

Provider View

This clinical trial is comparing a new treatment combination of ERC1671, GM-CSF, and Cyclophosphamide with Bevacizumab against a placebo in patients with recurring or progressing glioblastoma multiforme and gliosarcoma, who have not previously received Bevacizumab.

Patient Parameters

Program Overview

The purpose of this Phase II study is to see how well a new treatment combination works for patients with glioblastoma multiforme or gliosarcoma that has come back or is getting worse. The study compares the effects of ERC1671, GM-CSF, and Cyclophosphamide with Bevacizumab to a placebo treatment with Bevacizumab. The study is double-blinded, meaning neither the patients nor the researchers know who is receiving the actual treatment or the placebo. The treatment cycle lasts 28 days, with ERC1671 and GM-CSF given as skin injections and Cyclophosphamide taken as a pill. Bevacizumab is given every two weeks as part of the standard care.

Description

This study involves patients with glioblastoma multiforme or gliosarcoma that has returned or is worsening. Participants will be randomly assigned to receive either the new treatment combination of ERC1671, GM-CSF, and Cyclophosphamide with Bevacizumab or a placebo with Bevacizumab. The study is double-blinded, so neither the participants nor the researchers will know who is receiving the actual treatment. ERC1671 and GM-CSF are administered through skin injections, while Cyclophosphamide is taken orally. Bevacizumab is given as part of the standard care every two weeks. Each treatment cycle lasts 28 days. The study aims to determine if this new combination can better manage the disease compared to the placebo.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of glioblastoma multiforme or gliosarcoma (WHO Grade IV).
  • Have a performance status score of 70% or higher, meaning able to care for oneself with some assistance.
  • Have a life expectancy of more than 12 weeks.
  • Be experiencing the first or second relapse of glioblastoma.
  • Have previously undergone surgery, radiation therapy, and treatment with temozolomide.
  • Have an MRI showing the tumor at least 4 weeks after surgery or radiation, unless confirmed by biopsy.
  • Have resolved any side effects from previous treatments to a mild level, except for hair loss and blood-related side effects.
  • Be on a low dose of steroids if needed for brain swelling.
  • Have measurable disease before surgery.
  • Have normal organ and blood function, including specific blood cell counts and liver and kidney function.
  • Agree to use contraception if sexually active during the study.

Exclusion Criteria

  • Cannot undergo an MRI with contrast.
  • Have widespread disease in the brain or spinal cord.
  • Have a history or suspicion of cancer spread to other parts of the body.
  • Have used immunosuppressive drugs recently, except for low-dose steroids for brain swelling.
  • Have previously received Bevacizumab or similar drugs.
  • Have allergies to Bevacizumab components.
  • Have recent bleeding in the brain, except for minor changes related to surgery.
  • Have significant blood vessel disease or recent blood clots.
  • Have bleeding disorders or abnormal blood clotting tests.
  • Have recent serious abdominal issues like fistulas or perforations.
  • Have high levels of protein in urine.
  • Need major surgery during the study.
  • Have serious wounds or infections.
  • Have uncontrolled high blood pressure or other serious health conditions.
  • Have had recent heart or blood vessel issues.
  • Are pregnant or breastfeeding.
  • Have had another cancer in the last three years, except for certain skin, cervical, or prostate cancers.

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