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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.
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.
Control: Historical Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Solid Tumors Stage II, Stage III and Stage IV
AlloStim, Cryoablation, AlloStim, AlloStim, AlloStim, AlloStim, AlloStim
Hadassah-Hebrew University Medical Center
Not yet recruiting
Immunovative Therapies, Ltd.
Published on BioPortfolio: 2014-08-27T03:16:02-0400
This phase I/II clinical investigation is designed to determine the safety and anti-tumor effects of intravenous administration of the experimental immunotherapy drug, called AlloStim. Th...
The purpose of this study is to determine the safety and anti-tumor effects of an experimental immunotherapy drug, called AlloStim, which is intentionally mis-matched immune cells which ar...
This is a Phase I/II study to investigate the feasibility of creating a personalized therapeutic cancer vaccine within the body. A vaccine contains a source of tumor antigen and an adjuva...
This is a single center, open label dose frequency escalation study of InSituVax personalized anti-tumor vaccine protocol combining the cryoablation of a selected metastatic lesion with in...
The purpose of this study is to determine the safety and tolerability of personalized anti-cancer vaccine AlloVax(TM) in Subjects with confirmed recurrent or metastatic squamous cell carci...
To investigate the effects of pirfenidone (PFD) on post-cryoablation inflammation in a mouse model.
To determine whether a 3D printed model improves patients' understanding of renal cryoablation and the involved anatomy.
To compare the oncological outcomes of percutaneous cryoablation (PCA) versus robot-assisted partial nephrectomy (RPN) for the treatment of T1 renal tumors.
Radiofrequency catheter ablation (RFCA) in the septum close to the atrioventricular node (AVN) or His bundle has an increased risk of irreversible complications. Cryothermal energy has the advantages ...
Liver metastases occur in approximately 4%-14% of gastric cancer patients and are associated with high mortality. However, no standardized treatment approach is available for these patients. We aimed ...
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)
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
Cancer is not just one disease but many diseases. There are more than 100 different types of cancer. Most cancers are named for the organ or type of cell in which they start - for example, cancer that begins in the colon is called colon cancer; cancer th...
A vaccine is a biological preparation that improves immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe, its toxins or one ...