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Experimental Therapeutic Cancer Vaccine Created In-situ in Patients With Stage II-Stage IV Cancer

2014-08-27 03:16:02 | BioPortfolio

Summary

A Phase I/II study of an in-situ therapeutic cancer vaccine. Vaccines contain a source of antigen and and adjuvant. In this study the source of tumor antigen comes from the killing of a selected tumor by cryoablation (killing using extreme cold) and the adjuvant is intentionally mis-matched immune cells (AlloStim-TM) engineered to produce inflammatory cytokines.

Description

This is a Phase I/II clinical study to investigate the optimal protocol and indication for creating a personalized anti-tumor vaccine within the body of patients with cancer. The aim of the study is to evaluate the safety of administration and anti-tumor effect of a vaccine protocol that has three separate steps. Cancer patients generally present with an immune response to cancer biased to a Th2 response, while a Th1 response is considered necessary for mediating anti-tumor immunity. The first step of the study consists of multiple intradermal priming doses of AlloStimTM. The aim of this step is to create Th1 immunity to the alloantigens in AlloStimTM, thus increasing the number of Th1 cells in circulation. The second step of the protocol involves the cryoablation of a selected tumor lesion followed by an intratumoral AlloStimTM injection. The aim of this step is to generate tumor-specific CTL killer cells in the circulation. The final step is an intravenous infusion of AlloStimTM. The aim of this step is to activate circulating Th1 cells, killer cells, and natural killer cells. The further aim of this step is to create an inflammatory environment that can break-down the ability of the tumor to avoid an anti-tumor immune response. In patients with partial responses and recurrence of disease, additional intravenous "booster" infusions are utilized to reactivate the circulating immune cells.

Study Design

Control: Historical Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Solid Tumors Stage II, Stage III and Stage IV

Intervention

AlloStim, Cryoablation, AlloStim, AlloStim, AlloStim, AlloStim, AlloStim

Location

Hadassah-Hebrew University Medical Center
Jerusalem
Israel
91120

Status

Not yet recruiting

Source

Immunovative Therapies, Ltd.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:02-0400

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Medical and Biotech [MESH] Definitions

Garbage, refuse, or sludge, or other discarded materials from a wastewater treatment plant, water supply treatment plant, and air pollution control facility that include solid, semi-solid, or contained material. It does not include materials dissolved in domestic sewage, irrigation return flows, or industrial discharges.

Fractionation of a vaporized sample as a consequence of partition between a mobile gaseous phase and a stationary phase held in a column. Two types are gas-solid chromatography, where the fixed phase is a solid, and gas-liquid, in which the stationary phase is a nonvolatile liquid supported on an inert solid matrix.

Removal of tissue by vaporization, abrasion, or destruction. Methods used include heating tissue by hot liquids or microwave thermal heating, freezing (CRYOABLATION), chemical ablation, and photoablation with LASERS.

The action by which the surface of a liquid where it contacts a solid is elevated or depressed, because of the relative attraction of the molecules of the liquid for each other and for those of the solid. (McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed)

A phenomenon in which the surface of a liquid where it contacts a solid is elevated or depressed, because of the relative attraction of the molecules of the liquid for each other and for those of the solid. (from McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed)

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