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

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ClinicalTrials.gov Identifier: NCT01081223
Recruitment Status : Completed
First Posted : March 5, 2010
Last Update Posted : June 6, 2013
Sponsor:
Information provided by (Responsible Party):
TVAX Biomedical

Tracking Information
First Submitted Date  ICMJE March 3, 2010
First Posted Date  ICMJE March 5, 2010
Last Update Posted Date June 6, 2013
Study Start Date  ICMJE April 2010
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 3, 2012)
  • Relative toxicity [ Time Frame: 8 weeks ]
    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 ]
    Evaluate progression free survival at 6 months as a surrogate for overall survival.
Original Primary Outcome Measures  ICMJE
 (submitted: March 3, 2010)
Relative toxicity [ Time Frame: 8 weeks ]
To determine the relative toxicity (safety) of vaccinating recurrent grade III/IV glioma patients five times with viable cancer cells combined with GM-CSF. Toxicity will be assessed following delivery of each treatment component.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2012)
  • Immunogenicity [ Time Frame: 8 weeks ]
    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 ]
    Evaluate overall survival of patients
Original Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2010)
Potency [ Time Frame: 8 weeks ]
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 III/IV glioma subjects five times with attenuated cancer cells stimulates more powerful immune responses than vaccinating subjects twice with viable cancer cells. Clinical effects also will be measured.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase I/II Study To Test The Safety and Efficacy of TVI-Brain-1 As A Treatment For Recurrent Grade IV Glioma
Official Title  ICMJE Phase I/II Study To Test The Safety and Efficacy of TVI-Brain-1 As A Treatment For Recurrent Grade IV Glioma
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Glioma
  • High Grade Astrocytoma
  • Glioblastoma Multiforme
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: TVI-Brain-1
Biological/Vaccine: Cancer vaccine plus immune adjuvant, plus activated white blood cells
Intervention: Biological: Cancer vaccine plus immune adjuvant, plus activated white blood cells
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 8, 2011)
14
Original Estimated Enrollment  ICMJE
 (submitted: March 3, 2010)
10
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01081223
Other Study ID Numbers  ICMJE TVI-AST-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party TVAX Biomedical
Study Sponsor  ICMJE TVAX Biomedical
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Salacz, M.D. St. Luke's Hospital
PRS Account TVAX Biomedical
Verification Date June 2013

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