Study To Test the Safety and Efficacy of TVI-Brain-1 As A Treatment for Recurrent Grade IV Glioma

Last updated: June 27, 2023
Sponsor: TVAX Biomedical
Overall Status: Completed

Phase

2

Condition

Gliomas

Brain Cancer

Cancer/tumors

Treatment

TVI-Brain-1

Clinical Study ID

NCT01290692
TVI-AST-005
  • Ages > 18
  • All Genders

Study Summary

TVI-Brain-1 is an experimental treatment that takes advantage of the fact that your body can produce immune cells, called 'killer' white blood cells that have the ability to kill large numbers of the cancer cells that are present in your body. TVI-Brain-1 is designed to generate large numbers of those 'killer' white blood cells and to deliver those cells into your body so that they can kill your cancer cells.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age > 18
  • Informed consent
  • Diagnosis of grade IV glioma with progression following standard treatment.
  • Must be able to tolerate surgery to provide tumor tissue for vaccine.
  • Must be able to produce viable vaccine from tumor tissue.
  • Karnofsky Performance Status must be 70 or greater.
  • Negative HIV test.
  • Negative for hepatitis B and C virus.
  • Respiratory reserve must be reasonable.
  • Sufficient renal function.
  • Satisfactory blood counts.
  • Negative pregnancy test for women of childbearing potential.

Exclusion

Exclusion Criteria:

  • Surgically removed cancer reveals that it is not grade IV glioma.
  • Concomitant life-threatening disease.
  • Active autoimmune disease.
  • Currently receiving chemotherapy or biological therapy for the treatment of cancer.
  • Currently receiving immunosuppressive drugs for any reason.
  • Prior treatment with Avastin or other anti-angiogenesis treatment within 6 months.
  • Prior treatment with Gliadel wafers.
  • Corticosteroids beyond peri-operative period.
  • Psychological, familial, sociological or geographical conditions that do not permitadequate medical follow-up and compliance with the study protocol.

Study Design

Total Participants: 14
Treatment Group(s): 1
Primary Treatment: TVI-Brain-1
Phase: 2
Study Start date:
June 01, 2011
Estimated Completion Date:
February 28, 2014

Study Description

The TVI-Brain-1 treatment involves several steps. First, the patient's cancer will be surgically removed to provide cells for the vaccine. Second, the patient will be vaccinated with the vaccine formulation. Third, the patient's blood will be filtered for killer T cell precursors which will then be cultured and stimulated to reach a higher (killer) activity level. Fourth, the activated cells will be infused into the patient's bloodstream so that they will be able to attack the cancer.

Connect with a study center

  • Saint Luke's Hospital

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Washington University

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Baylor University Medical Center

    Dallas, Texas 75246
    United States

    Site Not Available

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin 54311
    United States

    Site Not Available

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