Imvamune Vaccine for the Treatment of Non-melanoma Skin Cancer

  • STATUS
    Recruiting
  • End date
    Jul 27, 2023
  • participants needed
    45
  • sponsor
    Ivan Litvinov
Updated on 27 January 2021

Summary

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).

Description

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.

Details
Condition Basal cell carcinoma, Carcinoma, Squamous cell carcinoma, Vulvar Dysplasia and Carcinoma, Advanced Malignancies, basal cell carcinomas, basal cell carcinoma of skin, epidermoid carcinoma, squamous cell cancer, Non-melanoma Skin Cancer, Non-melanoma Skin Cancer, Non-melanoma Skin Cancer
Treatment IMVAMUNE
Clinical Study IdentifierNCT04410874
SponsorIvan Litvinov
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects must have histologically confirmed, BCC and/or SCC tumors located on the chest, back, thigh, or arm/forearm
Presence of clinically documented disease. Skin tumor should measure at least 10 mm in size and should be no larger than 5 cm in any axes. There should be no clinical suspicion of metastasis (i.e. no lymphadenopaties and no systemic symptoms)
Age > 18 years
Subjects must have a documented ECOG performance status of 0 or 1
Subjects could be treatment naive or could have had previous surgery or radiation
Subjects may have had prior radiation therapy. A minimum of 28 days (4 weeks) must have elapsed between the last dose of radiation and date of registration (14 days for a single palliative fraction of radiation to a non-target lesion). Subjects must have recovered from any acute toxic effects from radiation prior to registration (unless grade 1, irreversible and considered not clinically significant)
Previous surgery is permitted. A minimum of 28 days (4 weeks) must have elapsed between any major surgery and date of registration (7 days for minor surgery), provided that wound healing has occurred
Each subject must sign a consent form prior to registration/at registration and prior to tests which are study specific
Subjects must be accessible for treatment and follow-up. Subjects registered on this trial must be treated and followed at the McGill University Health Centre (MUHC) or McGill Affiliated/other participating hospitals
Laboratory requirements (must be done within 7 days prior to registration or at time of registration) as follows
White blood cell count 3.0x10^9/L
absolute neutrophils 1.5x10^9/L
hemoglobin 100g/L
platelets 75x10^9/L
INR 1.2
bilirubin 1.5x upper normal limit
AST and ALT 3.0x upper normal limit
serum creatinine 1.5x upper normal limit (or creatinine clearance of 60mL/min)

Exclusion Criteria

Cancers located on cosmetically/functionally important areas (i.e. face, neck, genitalia, hands, feet, and lower legs)
Tumor larger than 5 cm in size (any axes)
Metastatic disease (or suspicion of metastasis)
Tumors arising as part of a genetic syndrome (i.e., Bazex-Dupr-Christol, Basal Cell Nevus Syndrome, Rombo syndromes for BCC or Xeroderma Pigmentosa, Ferguson Smith, Grzybowski, Muir-Tore syndromes for SCC)
Immunosuppressed individuals (e.g. organ transplant recipients, patient with inherited immunodeficiencies, HIV+ individuals or individuals receiving immunosuppressive medications for other reasons)
Individuals that are not able or willing to sign an informed consent
Subjects with history of other active or current malignancies requiring active treatment
Patients undergoing concurrent treatments with other anti-cancer therapy or other investigational agents
Subjects with prior treatment with Imvamune
Subjects with serious illness or medical condition that would not permit management
Subjects with uncontrolled pre-existing cardiovascular conditions and/or symptomatic cardiac dysfunction
Pregnant or lactating women. Men or women of childbearing potential who do not agree to use adequate contraception while on trial and 6 weeks following the trial
Subjects using anti-viral medications, steroids, immunosuppressive agents, or immunization (including the flu shot) within 14 days prior to registration. Patients who are at high risk of influenza infection (65 years and older, people of any age with certain chronic medical conditions (such as asthma, diabetes, or heart disease), pregnant women and children younger than 5 years), and who have not received an influenza vaccination during the flu season (i.e., October to May)
Subjects with a condition that could have resulted in splenic dysfunction (e.g. splenectomy, sickle cell anemia, radiation to the spleen 20Gy, congenital asplenism)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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