CompletedPhase 1/2

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

United States12 participantsStarted 2010-04

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants Experiencing the Incidence of Grade One or Higher Adverse Events

Timeframe: 8 weeks

Immunogenicity as Measured by Delayed Type Hypersensitivity Reactions

Timeframe: 48 hours

Trial details

NCT IDNCT01081223

SponsorTVAX Biomedical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-03

Results submitted2013-06-13

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