Back to resultsStudy To Test the Safety and Efficacy of TVI-Brain-1 As A Treatment for Recurrent Grade IV Glioma
Primary Purpose
Grade IV Glioma, Grade IV Astrocytoma, Glioblastoma Multiforme
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TVI-Brain-1
Sponsored by
About this trial
This is an interventional treatment trial for Grade IV Glioma focused on measuring Brain Neoplasms, Central Nervous System Neoplasms, Brain Diseases, Neoplasms, Nervous System Neoplasms, Glioblastoma, Astrocytoma, Nervous System Diseases, Central Nervous System Diseases, Glioma, Recurrent astrocytoma, Recurrent glioma, Cancer vaccine, Immunotherapy, Killer T cells, Activated T cells, GM-CSF, Activated lymphocytes
Eligibility 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.
- 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
- Saint Luke's Hospital
- Washington University
- Baylor University Medical Center
- Aurora BayCare Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TVI-Brain-1
Arm Description
All patients will receive the full TVI-Brain-1 treatment.
Outcomes
Primary Outcome Measures
Progression of Disease
To assess the efficacy of TVI-Brain-1 on patients to evaluate progression free survival. MRI data is used to evaluate tumor progression; success is defined if a patient is still alive and has < 25 % increase in Tumor volume in MRI collected at 6 month timepoint.
Secondary Outcome Measures
Overall Survival
All patients will be followed until death or the end of the study to measure overall survival.
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Toxicity will be assessed throughout the study by recording clinical symptoms, performing physical examinations, measuring vital signs and performing clinical laboratory tests, including complete blood counts and differentials, blood chemistries and autoimmune profiles.
Time to Progression of Tumor Per MRI
Time to progression is defined date of evidence of increase in tumor volume as evaluated by review and analysis of imaging, using MacDonald Criteria in review of serial MRI's taken at specific timepoints
Objective Response Rate
Time to progression is defined as assessed by neurologists and radiologists evaluation of time to worsening of patient's neurological status and/or increase in tumor volume measurements as evaluated by review and analysis of serial physical exams and MRI's taken at specific timepoints
Delayed-type Hypersensitivity (DTH) Skin Testing
Skin Test using attenuated autologous cancer cells will be performed to assess the immunogenicity of the Subject's cancer.
Evidence of a Resulting wheal or flare reaction from sub-cutanous injection of test will be evaluated in each patient
Quality of Life as Measured by FACT-Br Tool Score
Quality of life data using the FACT-Br score tabulation from responses on validated tool
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01290692
Brief Title
Study To Test the Safety and Efficacy of TVI-Brain-1 As A Treatment for Recurrent Grade IV Glioma
Official Title
Phase 2 Study To Test The Safety and Efficacy of TVI-Brain-1 As A Treatment For Recurrent Grade IV Glioma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TVAX Biomedical
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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
Grade IV Glioma, Grade IV Astrocytoma, Glioblastoma Multiforme
Keywords
Brain Neoplasms, Central Nervous System Neoplasms, Brain Diseases, Neoplasms, Nervous System Neoplasms, Glioblastoma, Astrocytoma, Nervous System Diseases, Central Nervous System Diseases, Glioma, Recurrent astrocytoma, Recurrent glioma, Cancer vaccine, Immunotherapy, Killer T cells, Activated T cells, GM-CSF, Activated lymphocytes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TVI-Brain-1
Arm Type
Experimental
Arm Description
All patients will receive the full TVI-Brain-1 treatment.
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.
Primary Outcome Measure Information:
Title
Progression of Disease
Description
To assess the efficacy of TVI-Brain-1 on patients to evaluate progression free survival. MRI data is used to evaluate tumor progression; success is defined if a patient is still alive and has < 25 % increase in Tumor volume in MRI collected at 6 month timepoint.
Time Frame
6-months
Secondary Outcome Measure Information:
Title
Overall Survival
Description
All patients will be followed until death or the end of the study to measure overall survival.
Time Frame
32 months
Title
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Description
Toxicity will be assessed throughout the study by recording clinical symptoms, performing physical examinations, measuring vital signs and performing clinical laboratory tests, including complete blood counts and differentials, blood chemistries and autoimmune profiles.
Time Frame
12 weeks
Title
Time to Progression of Tumor Per MRI
Description
Time to progression is defined date of evidence of increase in tumor volume as evaluated by review and analysis of imaging, using MacDonald Criteria in review of serial MRI's taken at specific timepoints
Time Frame
32-months
Title
Objective Response Rate
Description
Time to progression is defined as assessed by neurologists and radiologists evaluation of time to worsening of patient's neurological status and/or increase in tumor volume measurements as evaluated by review and analysis of serial physical exams and MRI's taken at specific timepoints
Time Frame
32-months
Title
Delayed-type Hypersensitivity (DTH) Skin Testing
Description
Skin Test using attenuated autologous cancer cells will be performed to assess the immunogenicity of the Subject's cancer.
Evidence of a Resulting wheal or flare reaction from sub-cutanous injection of test will be evaluated in each patient
Time Frame
48 hours
Title
Quality of Life as Measured by FACT-Br Tool Score
Description
Quality of life data using the FACT-Br score tabulation from responses on validated tool
Time Frame
32 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Wood, Ph.D.
Organizational Affiliation
Sponsor GmbH
Official's Role
Study Chair
Facility Information:
Facility Name
Saint Luke's Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Aurora BayCare Medical Center
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54311
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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
Links:
URL
http://www.tvaxbiomedical.com
Description
Sponsor website
Learn more about this trial
Study To Test the Safety and Efficacy of TVI-Brain-1 As A Treatment for Recurrent Grade IV Glioma
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