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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01290692
Recruitment Status : Completed
First Posted : February 7, 2011
Last Update Posted : October 24, 2016
Information provided by (Responsible Party):
TVAX Biomedical

Brief 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.

Condition or disease Intervention/treatment Phase
Grade IV Glioma Grade IV Astrocytoma Glioblastoma Multiforme Biological: TVI-Brain-1 Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study To Test The Safety and Efficacy of TVI-Brain-1 As A Treatment For Recurrent Grade IV Glioma
Study Start Date : June 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: TVI-Brain-1
All patients will receive the full TVI-Brain-1 treatment.
Biological: TVI-Brain-1
Following surgery, tumor tissue is used to generate a cancer vaccine. Patients are vaccinated with neutralized cells to initiate an immune response. Following vaccinations, the patient's white blood cells are collected, the white blood cells are stimulated and expanded, and are then reinfused into the patient's blood.
Other Name: Cancer vaccine plus immune adjuvant, plus activated white blood cells

Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 6-months ]
    To assess the efficacy of TVI-Brain-1 using progression-free survival at 6-months as a surrogate for overall survival. Determining the effect of TVI-Brain-1 on overall survival is the study's most important secondary endpoint.

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 36-months ]
    All patients will be followed until death to measure overall survival.

  2. Quality of life [ Time Frame: 36-months ]
    Patient quality of life will be assessed throughout the study.

  3. Toxicity [ Time Frame: 12 weeks ]
    Toxicity will be assessed throughout the study by recording clinical symptoms, performing physical examinations, measuring vital signs and performing clinical laboratory tests, including complete blood counts and differentials, blood chemistries and autoimmune profiles.

  4. Time to progression [ Time Frame: 36-months ]
    Time-to-progression will be assessed for all patients.

  5. Objective response rate [ Time Frame: 36-months ]
    Objective response rate will be assessed.

  6. Cancer immunogenicity [ Time Frame: 36-months ]
    Immunogenic responses to cancer cell vaccination will be measured.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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 permit adequate medical follow-up and compliance with the study protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01290692

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United States, Missouri
Saint Luke's Hospital
Kansas City, Missouri, United States, 64111
Washington University
Saint Louis, Missouri, United States, 63110
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
United States, Wisconsin
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States, 54311
Sponsors and Collaborators
TVAX Biomedical
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Study Chair: Gary Wood, Ph.D. Sponsor GmbH
Additional Information:
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Responsible Party: TVAX Biomedical Identifier: NCT01290692    
Other Study ID Numbers: TVI-AST-005
First Posted: February 7, 2011    Key Record Dates
Last Update Posted: October 24, 2016
Last Verified: October 2016
Keywords provided by TVAX Biomedical:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Cancer vaccine
Brain Diseases
Nervous System Diseases
Central Nervous System Diseases
Recurrent astrocytoma
Recurrent glioma
Killer T cells
Activated T cells
Activated lymphocytes
Additional relevant MeSH terms:
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Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs