AlloStim® Immunotherapy Dosing Alone or in Combination With Cryoablation in Metastatic Colorectal Cancer

Inclusion Criteria

• Adult males and female subjects aged 18-80 years at screening visit
• Pathologically confirmed diagnosis of colorectal adenocarcinoma
• Presenting with metastatic disease:
• Primary can be intact or previously resected
• Metastatic lesion(s) in liver must be non-resectable
• Extrahepatic disease acceptable
• At least one liver lesion able to be visualized by ultrasound and determined to be safely assessable for percutaneous cryoablation
• Previous treatment failure of two previous lines of active systemic chemotherapy:
• Previous chemotherapy must have included an oxaliplatin-containing (e.g. FOLFOX) and an irinotecan-containing (e.g. FOLFIRI) regimen
• with or without bevacizumab
• administered in adjuvant setting or for treatment of metastatic disease
• If KRAS wild type, must have at least one prior anti-EGFR therapy
• Treatment failure can be due to disease progression or toxicity
• Disease progression on second line therapy must be documented radiologically and must have occurred during or within 30 days following the last administration of treatment for metastatic disease
• ECOG performance score: 0-1
• Adequate hematological function:
• Absolute granulocyte count ≥ 1,200/mm3
• Platelet count ≥ 100,000/mm3
• PT/INR ≤ 1.5 or correctable to 2 weeks) of greater than physiologic doses of a corticosteroid agent (dose equivalent to > 5 mg/day of prednisone) within 30 days of the first day of study drug treatment
• Topical corticosteroids are permitted
• Prior diagnosis of an active autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, autoimmune thyroid disease, uveitis). Well controlled Type I diabetes allowed
• Prior experimental therapy
• History of blood transfusion reactions
• Known allergy to bovine products
• Progressive viral or bacterial infection
• All infections must be resolved and the subject must remain afebrile for seven days without antibiotics prior to being placed on study
• Cardiac disease of symptomatic nature
• History of HIV positivity or AIDS
• 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 and biopsy procedures
• History of severe hypersensitivity to monoclonal antibody drugs or any contraindication to any of the study drugs
• Psychiatric or addictive disorders or other condition that, in the opinion of the investigator, would preclude study participation.
• Subjects that lack ability to provide consent for themselves