Phase I/II Study To Test The Safety and Efficacy of TVI-Brain-1 As A Treatment For Recurrent Grade IV Glioma

Completed · Phase 1/Phase 2

Conditions studied: Glioma, High Grade Astrocytoma, Glioblastoma Multiforme

In brief

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.

Key facts

Study ID

NCT01081223

Run by

TVAX Biomedical

People needed

12

Starts

2010-04-01

Expected to finish

2011-03-01

Last updated by the study team

2023-06-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Saint Luke's Hospital — Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

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