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Central Nervous System Neoplasms

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All Drugs and Chemicals

Vaccines

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Adjuvants, Immunologic

Immunologic Factors

Cancer vaccine plus immune adjuvant Biological/vaccine Other

Tumor tissue is used for cancer vaccine. Following vaccinations, white blood cells are collected, stimulated and expanded, and are then reinfused. The infusion is followed by a course of low-dose IL-2.

Cancer vaccine plus immune adjuvant

Michael Salacz, M.D.

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.

TVI-Brain-1 involves several steps. First, the patient's cancer will be surgically removed to provide cells for the vaccine. Second, the patient will be vaccinated twice with those cells and GM-CSF. Third, the patient's blood will be filtered for white cells which will then be cultured and stimulated to reach a higher (killer) activity level. Fourth, the activated white blood cells will be infused into the patient's bloodstream so that they will be able to attack the cancer. Finally, the entire process starting with vaccination will be repeated, for a total of two rounds of therapy.

Phase I/II Study To Test The Safety and Efficacy of TVI-Brain-1 As A Treatment For Recurrent Grade IV Glioma

To determine the relative toxicity (safety) of vaccinating recurrent grade IV glioma patients four times with live, attenuated cancer cells combined with granulocyte-macrophage colony-stimulating factor (GM-CSF). Toxicity will be assessed following delivery of each treatment component.

The potency of the modified vaccination regimen will be assessed by measuring immune responses following each vaccination. The study is designed to determine whether vaccinating recurrent grade IV glioma subjects four times with attenuated cancer cells stimulates more powerful immune responses than vaccinating subjects twice. Clinical effects also will be measured to determine whether the treatment causes the cancer to regress.

TVAX Biomedical

Systematic assessments by questionnaires and completion of CRF at each scheduled visit

Biological/Vaccine: Cancer vaccine plus immune adjuvant, plus activated white blood cells

TVI-Brain-1

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Latvia

Region of Enrollment

Gary Wood PhD

Number of participants that completed treatment protocol

Number of Participants Experiencing the Incidence of Grade One or Higher Adverse Events

Cancer vaccine plus immune adjuvant Biological/vaccine Other

Cancer vaccine plus immune adjuvant: Tumor tissue is used for cancer vaccine. Following vaccinations, white blood cells are collected, stimulated and expanded, and are then reinfused. The infusion is followed by a course of low-dose IL-2.

Ten patients developed an immunological response to their tumor as indicated by the delayed type hypersensitivity immune test.

Immunogenicity as Measured by Delayed Type Hypersensitivity Reactions

Overall Survival

Overall Study

Spots Global Cancer Trial Database for cancer vaccine plus immune adjuvant