Clinical Drug Experience Knowledgebase

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