- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01081223
Phase I/II Study To Test The Safety and Efficacy of TVI-Brain-1 As A Treatment For Recurrent Grade IV Glioma
May 4, 2023 updated by: TVAX Biomedical
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
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Missouri
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Kansas City, Missouri, United States, 64111
- Saint Luke's Hospital
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
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?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TVI-Brain-1
Cancer vaccine plus immune adjuvant Biological/vaccine Other
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Experiencing the Incidence of Grade One or Higher Adverse Events
Time Frame: 8 weeks
|
To determine the relative toxicity (safety) of vaccinating recurrent grade IV glioma patients four times with live, attenuated cancer cells combined with granulocyte-macrophage colony-stimulating factor (GM-CSF).
Toxicity will be assessed following delivery of each treatment component.
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8 weeks
|
Immunogenicity as Measured by Delayed Type Hypersensitivity Reactions
Time Frame: 48 hours
|
The potency of the modified vaccination regimen will be assessed by measuring immune responses following each vaccination.
The study is designed to determine whether vaccinating recurrent grade IV glioma subjects four times with attenuated cancer cells stimulates more powerful immune responses than vaccinating subjects twice.
Clinical effects also will be measured to determine whether the treatment causes the cancer to regress.
|
48 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: 12 months
|
Evaluate overall survival of patients
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael Salacz, M.D., St. Luke's Hospital
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.
Helpful Links
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 Major Dates
Study Start
April 1, 2010
Primary Completion (Actual)
March 1, 2011
Study Completion (Actual)
March 1, 2011
Study Registration Dates
First Submitted
March 3, 2010
First Submitted That Met QC Criteria
March 3, 2010
First Posted (Estimated)
March 5, 2010
Study Record Updates
Last Update Posted (Actual)
June 1, 2023
Last Update Submitted That Met QC Criteria
May 4, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Keywords
- Glioma
- Neoplasms
- Immunotherapy
- Nervous System Diseases
- Central Nervous System Diseases
- Glioblastoma
- Cancer vaccine
- Brain Diseases
- GM-CSF
- Astrocytoma
- Brain Neoplasms
- Central Nervous System Neoplasms
- Activated T cells
- Recurrent glioma
- Nervous System Neoplasms
- Recurrent astrocytoma
- Killer T cells
- Activated lymphocytes
- Low dose IL-2
Additional Relevant MeSH Terms
Other Study ID Numbers
- TVI-AST-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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