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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT01081223
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 TVAX Biomedical
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Michael Salacz, M.D.
Principal Investigator Affiliation St. Luke's Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioma, High Grade Astrocytoma, Glioblastoma Multiforme
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

Experimental: TVI-Brain-1

Cancer vaccine plus immune adjuvant Biological/vaccine Other

Interventions

Biological: - Cancer vaccine plus immune adjuvant

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Saint Luke's Hospital, Kansas City, Missouri

Status

Address

Saint Luke's Hospital

Kansas City, Missouri, 64111

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