In-Situ Therapeutic Cancer Vaccine for Metastatic Cancer Combining AlloStim With Tumor Cryoablation

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00861107
• Date of registration: 12/03/2009
• Prospective Registration: Yes
• Primary sponsor: Immunovative Therapies, Ltd.
• Public title: In-Situ Therapeutic Cancer Vaccine for Metastatic Cancer Combining AlloStim With Tumor Cryoablation
• Scientific title: Phase I/II Study of a Therapeutic Cancer Vacccine Created In-situ in Patients With Refractory or Metastatic Cancer
• Date of first enrolment: August 2009
• Target sample size: 50
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00861107
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Countries of recruitment

United States

Contacts

• Name: Dr. Michael Har-Noy
• Affiliation: Immunovative Therapies, Ltd.

• Name: Michael Berger, MD
• Affiliation: Immunotherapy Clinical Associates, PC

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Metastatic Cancer

Intervention(s)

Biological: AlloStim-7

Procedure: percutaneous tumor cryoablation

Biological: AlloStim8 or AlloStim-9

Primary Outcome(s)

evaluation of any drug-related toxicity associated with AlloStim administration as well as the reversibility of such toxicity. [Time Frame: 90 days]

Secondary Outcome(s)

evaluation of the immunological response to AlloStim administration [Time Frame: 90 days]

evaluation of the anti-tumor effect of AlloStim administration [Time Frame: 90 days]

Secondary ID(s)

ITL-002-CRYO

Source(s) of Monetary Support

Please refer to primary and secondary sponsors