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.

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.

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.

32 months

Adverse events were collected at all clinic visits through evaluation of blood chemistry and hematology labs, vital sign measurements, physical exams, and direct patient questioning.

Recruitment was stopped to allow a change in protocol design. Some positive clinical effects were observed but this study design treated Subjects whose cancers have progressed following surgery, radiotherapy, and temozolomide chemotherapy and therefore have immune systems that are too compromised to allow maximal benefit from the use of TVI-Brain-1. Study #008 is changed to treat newly diagnosed Subjects with healthy immune systems and minimal residual disease.