This trial is active, not recruiting.

Conditions grade iv glioma, grade iv astrocytoma, glioblastoma multiforme
Treatment tvi-brain-1
Phase phase 2
Sponsor TVAX Biomedical
Start date June 2011
End date December 2013
Trial size 86 participants
Trial identifier NCT01290692, TVI-AST-005


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
All patients will receive the full TVI-Brain-1 treatment.
tvi-brain-1 Cancer vaccine plus immune adjuvant, plus activated white blood cells
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.

Primary Outcomes

Progression Free Survival
time frame: 6-months

Secondary Outcomes

Overall Survival
time frame: 36-months
Quality of life
time frame: 36-months
time frame: 12 weeks
Time to progression
time frame: 36-months
Objective response rate
time frame: 36-months
Cancer immunogenicity
time frame: 36-months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Phase 2 Study To Test The Safety and Efficacy of TVI-Brain-1 As A Treatment For Recurrent Grade IV Glioma
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2012.
Information provided to ClinicalTrials.gov by TVAX Biomedical.