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NCT Number: NCT01290692

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.

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Key information

Conditions

Grade IV Glioma Astrocytoma Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Glioblastoma Glioblastoma Multiforme Glioma Grade IV Astrocytoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Saint Luke's Hospital, Kansas City, Missouri, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TVI-Brain-1

Biological

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 names: Cancer vaccine plus immune adjuvant plus activated WBC

Primary outcomes

  1. Progression of Disease

    Time frame: 6-months

    To assess the efficacy of TVI-Brain-1 on patients to evaluate progression free survival. MRI data is used to evaluate tumor progression; success is defined if a patient is still alive and has < 25 % increase in Tumor volume in MRI collected at 6 month timepoint.

Secondary outcomes

  1. Overall Survival

    Time frame: 32 months

    All patients will be followed until death or the end of the study to measure overall survival.

  2. Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0

    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.

  3. Time to Progression of Tumor Per MRI

    Time frame: 32-months

    Time to progression is defined date of evidence of increase in tumor volume as evaluated by review and analysis of imaging, using MacDonald Criteria in review of serial MRI's taken at specific timepoints

  4. Objective Response Rate

    Time frame: 32-months

    Time to progression is defined as assessed by neurologists and radiologists evaluation of time to worsening of patient's neurological status and/or increase in tumor volume measurements as evaluated by review and analysis of serial physical exams and MRI's taken at specific timepoints

  5. Delayed-type Hypersensitivity (DTH) Skin Testing

    Time frame: 48 hours

    Skin Test using attenuated autologous cancer cells will be performed to assess the immunogenicity of the Subject's cancer.

    Evidence of a Resulting wheal or flare reaction from sub-cutanous injection of test will be evaluated in each patient

  6. Quality of Life as Measured by FACT-Br Tool Score

    Time frame: 32 months

    Quality of life data using the FACT-Br score tabulation from responses on validated tool

Sponsors and collaborators

Lead sponsor

TVAX Biomedical

Industry

Registry information

Official study title

Phase 2 Study To Test The Safety and Efficacy of TVI-Brain-1 As A Treatment For Recurrent Grade IV Glioma

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Feb 7, 2011
Registry last updated
Jul 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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