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

Sponsor

TVAX Biomedical (Industry)

Overall Status

Completed

CT.gov ID

NCT01290692

Collaborator

(none)

Enrollment

Locations

Arm

32.1

Duration (Months)

21.5

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Grade IV Glioma Grade IV Astrocytoma Glioblastoma Multiforme	Biological: TVI-Brain-1	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

86 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Jun 1, 2011

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Feb 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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 Names: Cancer vaccine plus immune adjuvant, plus activated white blood cells

Arm

Intervention/Treatment

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 Names:

Cancer vaccine plus immune adjuvant, plus activated white blood cells

Outcome Measures

Primary Outcome Measures

Progression Free Survival [6-months]
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 [36-months]
All patients will be followed until death to measure overall survival.
Quality of life [36-months]
Patient quality of life will be assessed throughout the study.
Toxicity [12 weeks]
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 [36-months]
Time-to-progression will be assessed for all patients.
Objective response rate [36-months]
Objective response rate will be assessed.
Cancer immunogenicity [36-months]
Immunogenic responses to cancer cell vaccination will be measured.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Saint Luke's Hospital	Kansas City	Missouri	United States	64111
2	Washington University	Saint Louis	Missouri	United States	63110
3	Baylor University Medical Center	Dallas	Texas	United States	75246
4	Aurora BayCare Medical Center	Green Bay	Wisconsin	United States	54311