TVI-Brain-1 in Expanded Access Patient

Study Overview
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Brief Summary
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TVI-Brain-1 is being offered as a potential treatment option to a Named Patient (Emergency Use Authorization IND) for recurrent glioblastoma as there is no effective systemic treatment available for this disease or patient. 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
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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.

Official Title
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Expanded Access Use Of Tvi-Brain-1 For Treatment Of Recurrent Grade 4 Astrocytoma (Glioblastoma Multiforme; GBM)

Conditions
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Recurrent Glioblastoma

Intervention / Treatment
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* Biological: TVI-Brain 1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Recurrent glioblastoma diagnosis confirmed 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |