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About
This is a single center, open label dose frequency escalation study of CryoVax®. personalized anti-tumor vaccine protocol combining the cryoablation of a selected metastatic lesion with intra-lesional immunotherapy with AlloStim®. The in-situ (in the body) cancer vaccine step 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. The study will assess six different dosing schedules. A standard 3 plus 3 study design will be used. The starting frequency for each dosing schedule will be escalated in subsequent groups of patients. The study will evaluate safety of increased frequency of AlloStim® dosing and anti-tumor effect of the new proposed dose and frequency schedule.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Adult males and female subjects aged 18-80 years at screening visit
Pathologically confirmed diagnosis of colorectal adenocarcinoma
Presenting with metastatic disease:
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:
ECOG performance score: 0-1
Adequate hematological function:
Adequate Organ Function:
EKG without clinically relevant abnormalities
Female subjects: Not pregnant or lactating
Patients with child bearing potential must agree to use adequate contraception
Study specific informed consent in the native language of the subject.
Exclusion criteria
Bowel obstruction or high risk for obstruction
Moderate or severe ascites requiring medical intervention
Clinical evidence or radiological evidence of brain metastasis or leptomeningeal involvement
Symptomatic asthma or COPD
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 procedure
Regorafenib prior to the Study Period
Taking 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 first day of study drug treatment
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
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
Primary purpose
Allocation
Interventional model
Masking
12 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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