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NCT Number: NCT01081223

Phase I/II 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

Glioma Astrocytoma Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Glioblastoma Glioblastoma Multiforme High Grade 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 1 / Phase 2

Primary location

Saint Luke's Hospital

Kansas City, Missouri, 64111, United States

About this study

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.

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.
  • 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.

Treatment and study plan

Cancer vaccine plus immune adjuvant

Biological

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.

Primary outcomes

  1. Number of Participants Experiencing the Incidence of Grade One or Higher Adverse Events

    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.

  2. Immunogenicity as Measured by Delayed Type Hypersensitivity Reactions

    Time frame: 48 hours

    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.

Secondary outcomes

  1. Overall Survival

    Time frame: 12 months

    Evaluate overall survival of patients

Sponsors and collaborators

Lead sponsor

TVAX Biomedical

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 5, 2010
Registry last updated
Jun 1, 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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