Study To Test the Safety and Efficacy of TVI-Brain-1 As A Treatment for Recurrent Grade IV Glioma
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/14/2017 |
| Start Date: | June 2011 |
| End Date: | February 2014 |
Phase 2 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.
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.
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.
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.
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.
We found this trial at
4
sites
Aurora BayCare Medical Center Aurora BayCare Medical Center is a 167-bed, full-service hospital serving the...
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Baylor University Medical Center Baylor University Medical Center in Dallas, TX is ranked nationally in...
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