Back to resultsTVI-Brain-1 in Expanded Access Patient
Primary Purpose
Recurrent Glioblastoma
Status
Available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
TVI-Brain 1
Sponsored by
About this trial
This is an expanded access trial for Recurrent Glioblastoma
Eligibility Criteria
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.
Sites / Locations
- Providence St. Vincent Medical Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05936216
Brief Title
TVI-Brain-1 in Expanded Access Patient
Official Title
Expanded Access Use Of Tvi-Brain-1 For Treatment Of Recurrent Grade 4 Astrocytoma (Glioblastoma Multiforme; GBM)
Study Type
Expanded Access
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TVAX Biomedical
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Glioblastoma
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
TVI-Brain 1
Other Intervention Name(s)
Cancer vaccine plus immune adjuvant plus activated WBC
Intervention Description
Following surgery, tumor tissue is used to generate a cancer vaccine. Patients are vaccinated with neutralized cells to initiate an immune response. Following vaccinations, the patient's white blood cells are collected, the white blood cells are stimulated and expanded, and are then reinfused into the patient's blood.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gary Wood, PhD
Phone
(913) 492-2221
Email
gwood@tvaxbiomedical.com
Facility Information:
Facility Name
Providence St. Vincent Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Individual Site Status
Available
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prakash Ambady, M.D.
Phone
844-510-4325
12. IPD Sharing Statement
Citations:
PubMed Identifier
16817692
Citation
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.
Results Reference
background
PubMed Identifier
3264384
Citation
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.
Results Reference
background
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TVI-Brain-1 in Expanded Access Patient
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