Study To Test the Safety and Efficacy of TVI-Brain-1 As A Treatment for Recurrent Grade IV Glioma
This study is ongoing, but not recruiting participants.
Sponsor:
TVAX Biomedical
Information provided by (Responsible Party):
TVAX Biomedical
ClinicalTrials.gov Identifier:
NCT01290692
First received: February 3, 2011
Last updated: September 16, 2012
Last verified: September 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Grade IV Glioma Grade IV Astrocytoma Glioblastoma Multiforme |
Biological: TVI-Brain-1 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase 2 Study To Test The Safety and Efficacy of TVI-Brain-1 As A Treatment For Recurrent Grade IV Glioma |
Resource links provided by NLM:
Further study details as provided by TVAX Biomedical:
Primary Outcome Measures:
- Progression Free Survival [ Time Frame: 6-months ] [ Designated as safety issue: No ]To assess the efficacy of TVI-Brain-1 using progression-free survival at 6-months as a surrogate for overall survival. Determining the effect of TVI-Brain-1 on overall survival is the study's most important secondary endpoint.
Secondary Outcome Measures:
- Overall Survival [ Time Frame: 36-months ] [ Designated as safety issue: No ]All patients will be followed until death to measure overall survival.
- Quality of life [ Time Frame: 36-months ] [ Designated as safety issue: No ]Patient quality of life will be assessed throughout the study.
- Toxicity [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]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 [ Time Frame: 36-months ] [ Designated as safety issue: No ]Time-to-progression will be assessed for all patients.
- Objective response rate [ Time Frame: 36-months ] [ Designated as safety issue: No ]Objective response rate will be assessed.
- Cancer immunogenicity [ Time Frame: 36-months ] [ Designated as safety issue: No ]Immunogenic responses to cancer cell vaccination will be measured.
| Estimated Enrollment: | 86 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: TVI-Brain-1
All patients will receive the full TVI-Brain-1 treatment.
|
Biological: TVI-Brain-1
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.
Other Name: Cancer vaccine plus immune adjuvant, plus activated white blood 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01290692
Locations
| United States, Missouri | |
| Saint Luke's Hospital | |
| Kansas City, Missouri, United States, 64111 | |
| Washington University | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, Texas | |
| Baylor University Medical Center | |
| Dallas, Texas, United States, 75246 | |
| United States, Wisconsin | |
| Aurora BayCare Medical Center | |
| Green Bay, Wisconsin, United States, 54311 | |
Sponsors and Collaborators
TVAX Biomedical
Investigators
| Study Chair: | Gary Wood, Ph.D. | Sponsor GmbH |
More Information
Additional Information:
Publications:
| Responsible Party: | TVAX Biomedical |
| ClinicalTrials.gov Identifier: | NCT01290692 History of Changes |
| Other Study ID Numbers: | TVI-AST-005 |
| Study First Received: | February 3, 2011 |
| Last Updated: | September 16, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by TVAX Biomedical:
|
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 |
Additional relevant MeSH terms:
|
Astrocytoma Glioblastoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type |
Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013