This study examines the safety and efficacy of using the Imvamune smallpox vaccine in the treatment of non-melanoma skin cancers (basal cell carcinoma and squamous cell carcinoma).
One of the main ways cancer is able to develop is by hiding or evading our immune system which usually detects and kills potential tumor cells. Once cancer has developed the ability to evade the immune system it can continue to grow and become a tumor. One potential strategy currently being researched, called immunotherapy, uses viruses to stimulate an immune response which attacks the tumor. Imvamune is a live, non-replicating virus used in Canada to vaccinate adults and children against smallpox. It is safe to use in immunosuppressed patients because the virus is unable to replicate and spread past the first infected cell. This makes the Imvamune vaccine a viable candidate for immunotherapy in immunosuppressed patients who are at a much higher (up to 60x) risk of developing non-melanoma skin cancers.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Imvamune vaccine to be administered (via injection) intratumorally at one of three doses (1x10\^7, 1x10\^8, or 4x10\^8 PFU) twice, 4 days apart (first injection on Day 0 of the study and second injection on Day 4)
McGill University Health Centre
Montreal, Quebec, Canada
Maximum Tolerated Dose (MTD)
The MTD will be defined as the dose at which 2 or more patients experience a grade 3 or 4 adverse event (as defined by NCI Common Terminology Criteria for Adverse Events version 5.0) that is at least "probably related" to the study drug (ex: dose limiting toxicity).
Time frame: 25 days
Objective Tumor Response Rate (ORR)
Clinical and histological evaluation of the tumor to assess the development of immunity against BCC and/or SCC tumors or their protein markers.
Time frame: 25 days
Viral load in NMSC tumours
Ability to detect viral infection in the tumor.
Time frame: 25 days
Number of T cells/concentration of antigen specific antibodies
Ability to elicit increased immunological T/NKT cell mediated response, and antibody response against the tumor.
Time frame: 25 days
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