Study To Test the Safety and Efficacy of TVI-Brain-1 As A Treatment for Recurrent Grade IV Glioma - Full Text View

Sponsor:	TVAX Biomedical
Information provided by (Responsible Party):	TVAX Biomedical
ClinicalTrials.gov Identifier:	NCT01290692

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:

MedlinePlus related topics: Cancer Neurologic Diseases

U.S. FDA Resources

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

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

Contacts

Contact: Tim Wurst

913-492-2221

twurst@tvaxbiomedical.com

Locations

United States, Missouri
Saint Luke's Hospital	Recruiting
Kansas City, Missouri, United States, 64111
Contact: Jennifer McIntire, RN 816-932-4807 jmcintire@saint-lukes.org
Principal Investigator: Michael Salacz, MD
Washington University	Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Lisa Ochsner 314-286-2585 lochsner@dom.wustl.edu
Principal Investigator: David Tran, MD, Ph.D.
United States, Texas
Baylor University Medical Center	Recruiting
Dallas, Texas, United States, 75246
Contact: Valerie Clark, RN 214-820-6168 valerie.clark@baylorhealth.edu
Principal Investigator: Karen Fink, MD, Ph.D.
United States, Wisconsin
Aurora BayCare Medical Center	Recruiting
Green Bay, Wisconsin, United States, 54311
Contact: Lori McElrone, RN 920-288-4174 lori.mcelrone@aurorabaycare.com
Principal Investigator: Dhimant R. Patel, MD

Sponsors and Collaborators

TVAX Biomedical

Investigators

Study Chair:

Gary Wood, Ph.D.

Sponsor GmbH

More Information

Additional Information:

Sponsor website This link exits the ClinicalTrials.gov site

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.

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:	April 2, 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, 2012