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

This study is ongoing, but not recruiting participants.
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
History of Changes

February 3, 2011
September 16, 2012
June 2011
December 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01290692 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Study To Test the Safety and Efficacy of TVI-Brain-1 As A Treatment for Recurrent Grade IV Glioma
Phase 2 Study To Test The Safety and Efficacy of TVI-Brain-1 As A Treatment For Recurrent Grade IV Glioma

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.

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.
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Grade IV Glioma
  • Grade IV Astrocytoma
  • Glioblastoma Multiforme
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
Experimental: TVI-Brain-1
All patients will receive the full TVI-Brain-1 treatment.
Intervention: Biological: TVI-Brain-1
Sloan AE, Dansey R, Zamorano L, Barger G, Hamm C, Diaz F, Baynes R, Wood G. Adoptive immunotherapy in patients with recurrent malignant glioma: preliminary results of using autologous whole-tumor vaccine plus granulocyte-macrophage colony-stimulating factor and adoptive transfer of anti-CD3-activated lymphocytes. Neurosurg Focus. 2000 Dec 15;9(6):e9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
86
February 2014
December 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01290692
TVI-AST-005
No
TVAX Biomedical
TVAX Biomedical
Not Provided
Study Chair: Gary Wood, Ph.D. Sponsor GmbH
TVAX Biomedical
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP