- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01065441
Experimental Therapeutic Cancer Vaccine Created In-situ in Patients With Stage II-Stage IV Cancer
A Phase I/II Study of an Experimental Therapeutic Cancer Vaccine Created In-situ in Patients With Stage II-Stage IV Cancers
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Jerusalem, Israel, 91120
- Hadassah-Hebrew University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 years or older
- Stage II-IV including 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 or alcohol ablation located in liver, kidney, bone, lung, adrenal, pancreas, lymph node, skin, neck or prostate deemed to be accessible for percutaneous access or carcinomatosis or malignant ascites or malignant pleural effusion.
- When applicable, 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 >90 days
- No bevacizumab (Avastin®) within 6 weeks of planned cryoablation procedure
- ECOG status 0-2
- 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
o 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 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
o Topical and inhaled corticosteroids are permitted
- Concomitant active 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
o 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 o HBV and/or HCV positivity is permitted
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary endpoint is the evaluation of any drug-related toxicity associated with AlloStimTM administration as well as the reversibility of such toxicity.
Time Frame: 90 days
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90 days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The secondary end-point is the evaluation of the anti-tumor effect of AlloStimTM administration.
Time Frame: 1 year
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1 year
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The tertiary end-point is the evaluation of the immunological response to AlloStim-TM administration.
Time Frame: 90 days
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90 days
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Tamar Peretz, MD, Hadassah Medical Organization
- Study Chair: Dr. Michael Har-Noy, Immunovative Therapies, Ltd.
Publications and helpful links
General Publications
- Har-Noy M, Slavin S. The anti-tumor effect of allogeneic bone marrow/stem cell transplant without graft vs. host disease toxicity and without a matched donor requirement? Med Hypotheses. 2008;70(6):1186-92. doi: 10.1016/j.mehy.2007.10.008. Epub 2007 Dec 3.
- Har-Noy M, Zeira M, Weiss L, Fingerut E, Or R, Slavin S. Allogeneic CD3/CD28 cross-linked Th1 memory cells provide potent adjuvant effects for active immunotherapy of leukemia/lymphoma. Leuk Res. 2009 Apr;33(4):525-38. doi: 10.1016/j.leukres.2008.08.017. Epub 2008 Oct 1.
- Har-Noy M, Zeira M, Weiss L, Slavin S. Completely mismatched allogeneic CD3/CD28 cross-linked Th1 memory cells elicit anti-leukemia effects in unconditioned hosts without GVHD toxicity. Leuk Res. 2008 Dec;32(12):1903-13. doi: 10.1016/j.leukres.2008.05.007. Epub 2008 Jun 18.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Endocrine Gland Neoplasms
- Genital Neoplasms, Male
- Prostatic Diseases
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Neuroendocrine Tumors
- Nevi and Melanomas
- Sarcoma
- Prostatic Neoplasms
- Colorectal Neoplasms
- Ovarian Neoplasms
- Melanoma
Other Study ID Numbers
- ITL-002-HMC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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