Clinical Trials

TVAX is currently conducting a Phase 2 clinical trial and planning a Phase 3 clinical trial of TVI-Brain-1.  For the most complete and up-to-date details regarding recruitment, eligibility criteria, contact information and locations for our currently enrolling Phase 2 study, please visit ClinicalTrials.gov.

View current open TVAX studies at ClinialTrials.gov

The following information will provide a quick reference for whether you or someone you know might be a candidate for participation in our Phase 2 trial of TVI-Brain-1. 

Study Title:                                       
Phase 2 Study To Test The Safety and Efficacy of TVI-Brain-1 As A Treatment For Recurrent Grade IV Glioma

Status:
Currently enrolling at multiple sites in United States

Patient Eligibility:
Inclusion Criteria:

• Adults 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.

ClinicalTrials.gov provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions. The U.S. National Institutes of Health (NIH), through its National Library of Medicine (NLM), developed the ClinicalTrials.gov site in collaboration with the Food and Drug Administration (FDA).