Phase I/II Study To Test The Safety and Efficacy of TVI-Brain-1 As A Treatment For Recurrent Grade IV Glioma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TVAX Biomedical
ClinicalTrials.gov Identifier:
NCT01081223
First received: March 3, 2010
Last updated: June 4, 2013
Last verified: June 2013
  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
Glioma
High Grade Astrocytoma
Glioblastoma Multiforme
Biological: Cancer vaccine plus immune adjuvant, plus activated white blood cells
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II 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:
  • Relative toxicity [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    To determine the relative toxicity (safety) of vaccinating recurrent grade IV glioma patients four times with live, attenuated cancer cells combined with granulocyte-macrophage colony-stimulating factor (GM-CSF). Toxicity will be assessed following delivery of each treatment component.

  • Progression free survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Evaluate progression free survival at 6 months as a surrogate for overall survival.


Secondary Outcome Measures:
  • Immunogenicity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    The potency of the modified vaccination regimen will be assessed by measuring immune responses following each vaccination. The study is designed to determine whether vaccinating recurrent grade IV glioma subjects four times with attenuated cancer cells stimulates more powerful immune responses than vaccinating subjects twice. Clinical effects also will be measured to determine whether the treatment causes the cancer to regress.

  • Overall survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Evaluate overall survival of patients


Enrollment: 14
Study Start Date: April 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TVI-Brain-1
Biological/Vaccine: Cancer vaccine plus immune adjuvant, plus activated white blood cells
Biological: Cancer vaccine plus immune adjuvant, plus activated white blood cells
Tumor tissue is used for cancer vaccine. Following vaccinations, white blood cells are collected, stimulated and expanded, and are then reinfused. The infusion is followed by a course of low-dose IL-2.

Detailed Description:

TVI-Brain-1 involves several steps. First, the patient's cancer will be surgically removed to provide cells for the vaccine. Second, the patient will be vaccinated twice with those cells and GM-CSF. Third, the patient's blood will be filtered for white cells which will then be cultured and stimulated to reach a higher (killer) activity level. Fourth, the activated white blood cells will be infused into the patient's bloodstream so that they will be able to attack the cancer. Finally, the entire process starting with vaccination will be repeated, for a total of two rounds of therapy.

  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.
  • Eastern Cooperative Oncology Group (ECOG) performance status must be < 2 or 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01081223

Locations
United States, Missouri
Saint Luke's Hospital
Kansas City, Missouri, United States, 64111
Sponsors and Collaborators
TVAX Biomedical
Investigators
Principal Investigator: Michael Salacz, M.D. St Luke's Hospital
  More Information

Additional Information:
Publications:
Responsible Party: TVAX Biomedical
ClinicalTrials.gov Identifier: NCT01081223     History of Changes
Other Study ID Numbers: TVI-AST-002
Study First Received: March 3, 2010
Last Updated: June 4, 2013
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
Low dose IL-2
Activated lymphocytes

Additional relevant MeSH terms:
Astrocytoma
Glioblastoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014