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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by TVAX Biomedical.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
TVAX Biomedical
ClinicalTrials.gov Identifier:
NCT01290692
First received: February 3, 2011
Last updated: September 16, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Grade IV Glioma
Grade IV Astrocytoma
Glioblastoma Multiforme
Biological: TVI-Brain-1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by TVAX Biomedical:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: 6-months ] [ Designated as safety issue: No ]
    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:
  • Overall Survival [ Time Frame: 36-months ] [ Designated as safety issue: No ]
    All patients will be followed until death to measure overall survival.

  • Quality of life [ Time Frame: 36-months ] [ Designated as safety issue: No ]
    Patient quality of life will be assessed throughout the study.

  • Toxicity [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    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.

  • Time to progression [ Time Frame: 36-months ] [ Designated as safety issue: No ]
    Time-to-progression will be assessed for all patients.

  • Objective response rate [ Time Frame: 36-months ] [ Designated as safety issue: No ]
    Objective response rate will be assessed.

  • Cancer immunogenicity [ Time Frame: 36-months ] [ Designated as safety issue: No ]
    Immunogenic responses to cancer cell vaccination will be measured.


Estimated Enrollment: 86
Study Start Date: June 2011
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01290692

Locations
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
Investigators
Study Chair: Gary Wood, Ph.D. Sponsor GmbH
  More Information

Additional Information:
Publications:
Responsible Party: TVAX Biomedical
ClinicalTrials.gov Identifier: NCT01290692     History of Changes
Other Study ID Numbers: TVI-AST-005
Study First Received: February 3, 2011
Last Updated: September 16, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by TVAX Biomedical:
Brain Neoplasms
Central Nervous System Neoplasms
Brain Diseases
Neoplasms
Nervous System Neoplasms
Glioblastoma
Astrocytoma
Nervous System Diseases
Central Nervous System Diseases
Glioma
Recurrent astrocytoma
Recurrent glioma
Cancer vaccine
Immunotherapy
Killer T cells
Activated T cells
GM-CSF
Activated lymphocytes

Additional relevant MeSH terms:
Astrocytoma
Glioblastoma
Glioma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors

ClinicalTrials.gov processed this record on November 20, 2014