Status and phase
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About
This is a personalized anti-cancer vaccine protocol which includes an in-situ (in the body) cancer vaccine step which combines killing a single metastatic tumor lesion by use of cryoablation in order to cause the release of tumor-specific markers to the immune system and then injecting bioengineered allogeneic immune cells (AlloStim) into the lesion as an adjuvant in order to modulate the immune response and educate the immune system to kill other tumor cells where ever they reside in the body.
Full description
Colorectal cancer (CRC) ranks as the third most common cancer worldwide. Metastasis is the main reason of death in CRC patients. The current drugs used to treat colorectal cancer provide important treatment options for patients, their limitations including drug resistance, poor efficacy and severe side effects. Development of new therapeutic strategies for KRAS mutant as well as BRAF mutant tumors are therefore highly needed in order to offer a new category of drug (immunotherapy). This study targets the population of mCRC patients that have progressed after two lines of chemotherapy and are not eligible for targeted therapies due to a mutation in KRAS or BRAF.
This is a Phase II/III, randomized, open-label, multicenter, controlled, two arm study designed to determine the efficacy in terms of OS and the safety of the InSituVax (AlloStim+ Cryoablation) personalized in-situ anti-cancer vaccine protocol (Treatment Arm) compared with Physician's Choice (PC) of Treatment + Cryoablation (Control Arm) in Metastatic Colorectal Cancer. Subjects are randomized 2:1 into the treatment or control arms.
Sex
Ages
Volunteers
Inclusion criteria
Adult males and female subjects aged 18 years or older at screening visit
Pathological diagnosis of colorectal adenocarcinoma
Metastatic disease with at least one lesion in liver
KRAS/BRAF mutant disease or KRAS wild type w/previous anti-EGFR treatment
At least one liver lesion able to be visualized by ultrasound and determined to be safely assessable for percutaneous cryoablation
Previous treatment failure of at 2 previous lines of active systemic chemotherapy 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 <1.5 at time of interventional procedures, Hemoglobin ≥ 9 g/dL (may be corrected by transfusion)
Adequate Organ Function: Creatinine ≤ 1.5 mg/dL, Total bilirubin ≤ 1.5 times ULN, Alkaline phosphatase ≤ 2.5 times ULN, AST or SGOT ≤ 2.5 times ULN, ALT or SGPT≤2.5 times ULN
EKG without clinically relevant abnormalities
Female subjects: Not pregnant or lactating
Subjects with child bearing potential must agree to use adequate contraception
Study specific informed consent in the native language of the subject
Exclusion criteria
Peritoneal carcinomatosis
Moderate or severe ascites requiring medical intervention
Prior hepatectomy, ablation or chemoembolization of liver lesion
Prior pelvic radiotherapy
Clinical or radiological evidence of brain metastasis/leptomeningeal involvement
Symptomatic asthma or COPD or any lung condition requiring treatment with steroids
Pulmonary lymphangitis or symptomatic pleural effusion (grade ≥ 2) that results in pulmonary dysfunction requiring active treatment or oxygen saturation <92% on room air
Bevacizumab (Avastin®) treatment within 6 weeks of scheduled cryoablation
No Regorafenib prior to or during the Study Period
Anticoagulant medication for concomitant medical condition (unless can be safely discontinued for invasive cryoablation, biopsy and intratumoral injection procedures)
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>5 mg/day of prednisone) within 30 days of the 1st day of study treatment
o 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
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
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 procedure
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
Primary purpose
Allocation
Interventional model
Masking
0 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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