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Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Approved-not yet active	18 and over	Pharmaceutical / Industry	ITL-002-CRYO NCT00861107

Trial Description

Summary

This is a pilot 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 adjuvant. In this study, tumor antigen is generated by freezing a tumor by a minimally invasive percutaneous (through the skin) cryoablation procedure. The study drug, AlloStim, is injected into the ablated tumor to promote development of an anti-tumor immune response.

Further Study Information

This is a pilot clinical study to investigate the feasibility of creating a personalized anti-tumor vaccine within the body of patients with advanced cancers. The aim of the study is to evaluate the safety of administration and anti-tumor effect of a vaccine protocol that has three separate phases.

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 three (3) weekly intradermal priming doses of AlloStim. The aim of this step is to create Th1 immunity to the alloantigens in AlloStim, 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 AlloStim. 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.

Eligibility Criteria

Inclusion Criteria:

• 18 years or older

• Metastatic cancer refractory to at least one course of active chemotherapy or prior radiation therapy, including metastatic breast cancer, colorectal cancer, non-small cell lung cancer, ovarian or other gynecological cancer, prostate cancer, pancreatic or other GI cancer, melanoma, head or neck cancer or lymphoma/plasmacytoma.

• Measurable disease determined upon review of abdominal and/or chest CT scan within 60 days of evaluation for study inclusion with a target tumor lesion for cryoablation located in liver, kidney, bone, pancreas, lymph node, skin, neck or prostate deemed to be accessible for percutaneous access.

• Acceptable cryoablation procedure technique risk: the target tumor for ablation must have adequate distance from adjacent vasculature and other organs to permit safe application of cryoprobe (generally, more than a 2.5cm clearance of the cryoprobe from any vital structure such as the bowel, inferior vena cava, or aorta). The safety assessment of the cryoprobe placement will be made an attending radiologist based on imaging studies.

• Life expectancy >180 days

• No bevacizumab (Avastin®) within 6 weeks of planned cryoablation procedure

• ECOG status 0-1

• No concurrent medication known to interfere with platelet function or coagulation (e.g., aspirin, ibuprofen, clopidogrel, or warfarin) unless such medications can be discontinued for an appropriate time period based on the drug half-life and known activity (e.g., aspirin for 7 days) prior to cryoablation procedure

• No low molecular weight heparin preparations unless can be discontinued 8 hours prior to cryoablation

• At least 2 weeks since prior cytotoxic chemotherapy

• Absolute granulocyte count ≥ 1,200/mm3

• Platelet count ≥ 100,000/mm3

• PT/INR ≤ 1.5

• INR correctable to ≤ 1.5 or a PT/PTT correctable to normal limits. Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate. For patients on warfarin, the INR should be monitored weekly prior to the cryoablation day 21 to assure INR is stable. However, heparin or warfarin must be withheld prior to cryoablation such that the above criteria are met.

• Hemoglobin ≥ 9 g/dL

• Creatinine ≤ 1.5 mg/dL

• Total bilirubin ≤ 1.5 times normal

• Alkaline phosphatase ≤ 2.5 times normal (≤ 5 times normal if liver involvement)

• Aspartate aminotransferase (AST) or (SGOT) ≤ 2.5 times ULN

• Alanine aminotransferase (ALT) or (SGPT) ≤ 2.5 times ULN

• Not pregnant or lactating

• Patients with child bearing potential must agree to use adequate contraception

• No psychiatric or addictive disorders or other condition that, in the opinion of the investigator, would preclude study participation

• Study specific informed consent

Exclusion Criteria:

• Taking anticoagulant medication for concomitant medical condition (unless can be safely discontinued for cryoablation procedure)

• Prior allogeneic bone marrow/stem cell or solid organ transplant

• Chronic use (> 2 weeks) of greater than physiologic doses of a corticosteroid agent (dose equivalent to > 10 mg/day of prednisone) within 30 days of the first day of study drug treatment

• Topical and inhaled corticosteroids are permitted

• Concomitant autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, autoimmune thyroid disease, uveitis)

• Prior experimental cancer vaccine treatment (e.g., dendritic cell therapy, heat shock vaccine)

• Immunosuppressive therapy, including: cyclosporine, antithymocyte globulin, or tacrolimus within 3 months of study entry

• History of blood transfusion reactions

• Known allergy to bovine products

• Know allergy to murine products

• Progressive viral or bacterial infection

• All infections must be resolved and the patient must remain afebrile for seven days without antibiotics prior to being placed on study

• Cardiac disease of symptomatic nature or cardiac ejection fraction < 45%

• Symptomatic pulmonary disease or FEV1, FVC, and DLCO ≤ 50% predicted

• History of HIV positivity or AIDS

• HBV and/or HCV positivity is permitted

Trial Contact Information

Trial Lead Organizations/Sponsors

Immunovative Therapies, Limited

Dr. Michael Har-Noy

Study Director

Christopher Saucedo, MD

Principal Investigator

James Richards, RN, CRA		Ph: 760-444-9040
		Email: richardsj@immunovative.co.il

Hoang-Thu Bui, BS, CRC		Ph: 760-444-9040
		Email: thu@immunovative.co.il

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00861107
Information obtained from ClinicalTrials.gov on April 01, 2009