Official Title
Phase I/II Study To Test The Safety and Efficacy of TVI-Brain-1 As A Treatment For Recurrent Grade IV Glioma
Phase
Phase 1/Phase 2Lead Sponsor
TVAX BiomedicalStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Glioma High Grade Astrocytoma Glioblastoma MultiformeIntervention/Treatment
aldesleukin tvi-brain-1 white blood cells ...Study Participants
12TVI-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.
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.
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.
Cancer vaccine plus immune adjuvant Biological/vaccine Other
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.
| Event Type | Organ System | Event Term | TVI-Brain-1 |
|---|
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.
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.
Evaluate overall survival of patients
