- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05936216
TVI-Brain-1 in Expanded Access Patient
June 28, 2023 updated by: TVAX Biomedical
Expanded Access Use Of Tvi-Brain-1 For Treatment Of Recurrent Grade 4 Astrocytoma (Glioblastoma Multiforme; GBM)
TVI-Brain-1 is being offered as a potential treatment option to a Named Patient (Emergency Use Authorization IND) for recurrent glioblastoma as there is no effective systemic treatment available for this disease or patient.
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.
Study Overview
Detailed Description
The TVI-Brain-1 treatment involves several steps.
First, the patient's cancer will be surgically removed to provide cells for the vaccine.
Second, the patient will be vaccinated with the vaccine formulation.
Third, the patient's blood will be filtered for killer T cell precursors which will then be cultured and stimulated to reach a higher (killer) activity level.
Fourth, the activated cells will be infused into the patient's bloodstream so that they will be able to attack the cancer.
Study Type
Expanded Access
Expanded Access Type
- Individual Patients
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gary Wood, PhD
- Phone Number: (913) 492-2221
- Email: gwood@tvaxbiomedical.com
Study Locations
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Oregon
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Portland, Oregon, United States, 97225
- Available
- Providence St. Vincent Medical Center
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Contact:
- Prakash Ambady, M.D.
- Phone Number: 844-510-4325
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Description
Inclusion Criteria:
Recurrent glioblastoma diagnosis confirmed
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Sloan AE, Dansey R, Zamorano L, Barger G, Hamm C, Diaz F, Baynes R, Wood G. Adoptive immunotherapy in patients with recurrent malignant glioma: preliminary results of using autologous whole-tumor vaccine plus granulocyte-macrophage colony-stimulating factor and adoptive transfer of anti-CD3-activated lymphocytes. Neurosurg Focus. 2000 Dec 15;9(6):e9. doi: 10.3171/foc.2000.9.6.10.
- Rosenberg SA, Packard BS, Aebersold PM, Solomon D, Topalian SL, Toy ST, Simon P, Lotze MT, Yang JC, Seipp CA, et al. Use of tumor-infiltrating lymphocytes and interleukin-2 in the immunotherapy of patients with metastatic melanoma. A preliminary report. N Engl J Med. 1988 Dec 22;319(25):1676-80. doi: 10.1056/NEJM198812223192527.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
June 28, 2023
First Submitted That Met QC Criteria
June 28, 2023
First Posted (Actual)
July 7, 2023
Study Record Updates
Last Update Posted (Actual)
July 7, 2023
Last Update Submitted That Met QC Criteria
June 28, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TVI-AST-EAU
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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