Flu Vaccine for Melanoma
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on certain immunosuppressive medications or corticosteroids above a specific dose within 14 days of the study.
What data supports the effectiveness of the treatment for melanoma?
Is the flu vaccine safe for use in humans?
How does the Flu Vaccine treatment differ from other melanoma treatments?
The Flu Vaccine for Melanoma is unique because it uses a common flu vaccine to potentially stimulate the immune system against melanoma, unlike traditional treatments that focus on specific melanoma antigens. This approach is novel as it leverages the immune response typically generated by flu vaccines to target cancer cells.158910
What is the purpose of this trial?
This phase I trial investigates the effects of influenza vaccine in treating patients with stage I-IV melanoma. While intramuscular administration of influenza vaccine provides immunization against the influenza virus, giving influenza vaccine directly into the tumor (intralesional) may decrease the size of the injected melanoma tumor, or the extent of the melanoma within the body.
Research Team
Carlo M. Contreras, MD
Principal Investigator
Ohio State University Comprehensive Cancer Center
Eligibility Criteria
This trial is for adults aged 18-99 with stage I-IV cutaneous melanoma. Participants must have at least one palpable tumor deposit suitable for injection and be in good physical condition (ECOG PS 0-1). Exclusions include allergies to flu vaccines, recent immunosuppressants use, autoimmune diseases, ocular/mucosal melanoma, brain metastasis, recent melanoma therapy except surgery, incarceration, HIV positivity or pregnancy.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive quadrivalent inactivated influenza vaccine intramuscularly on day 0 and intratumorally on specified days, with surgery on day 28 for Cohort I and additional intratumoral doses for Cohort II
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Quadrivalent Inactivated Influenza Vaccine
Quadrivalent Inactivated Influenza Vaccine is already approved in United States, European Union, Canada, Japan, China, Switzerland for the following indications:
- Influenza prophylaxis
- Influenza prophylaxis
- Influenza prophylaxis
- Influenza prophylaxis
- Influenza prophylaxis
- Influenza prophylaxis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Carlo Contreras
Lead Sponsor