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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2014-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Grade IV Glioma Grade IV Astrocytoma Glioblastoma Multiforme

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TVI-Brain-1

All patients will receive the full TVI-Brain-1 treatment.

Group Type EXPERIMENTAL

TVI-Brain-1

Intervention Type BIOLOGICAL

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.

Interventions

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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.

Intervention Type BIOLOGICAL

Other Intervention Names

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Cancer vaccine plus immune adjuvant plus activated WBC

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No