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
1 other identifier
interventional
9
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Dec 2010
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 7, 2010
CompletedFirst Posted
Study publicly available on registry
February 9, 2010
CompletedStudy Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedJanuary 22, 2020
January 1, 2020
2 years
February 7, 2010
January 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary endpoint is the evaluation of any drug-related toxicity associated with AlloStimTM administration as well as the reversibility of such toxicity.
90 days
Secondary Outcomes (2)
The secondary end-point is the evaluation of the anti-tumor effect of AlloStimTM administration.
1 year
The tertiary end-point is the evaluation of the immunological response to AlloStim-TM administration.
90 days
Interventions
Patients meeting eligibility criteria will be primed with at least three and up to nine intradermal AlloStim-TM injections at a frequency of every 2-8 days at doses between 1-4 x 10\^7 cells
Percutaneous cryoablation of selected tumor lesion under CT or US guidance
Eligibility Criteria
You may qualify if:
- 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.
- 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
- +8 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Michael Har-Noylead
- Hadassah Medical Organizationcollaborator
Study Sites (1)
Hadassah-Hebrew University Medical Center
Jerusalem, 91120, Israel
Related Publications (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.
PMID: 18834631BACKGROUNDHar-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.
PMID: 18565579BACKGROUNDHar-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.
PMID: 18054441BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tamar Peretz, MD
Hadassah Medical Organization
- STUDY CHAIR
Dr. Michael Har-Noy
Mirror Biologics, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Investigator: Dept of Bone Marrow Transplantation and Immunotherapy
Study Record Dates
First Submitted
February 7, 2010
First Posted
February 9, 2010
Study Start
December 1, 2010
Primary Completion
December 1, 2012
Study Completion
July 1, 2013
Last Updated
January 22, 2020
Record last verified: 2020-01