RECRUITING

Intralesional Influenza Vaccine for the Treatment of Stage I-IV Melanoma

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Intralesional Influenza Vaccine for Patients with Melanoma

Quick Facts

Study Start:2021-10-20
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04697576

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 to 99 years of age
  2. * Histologically confirmed cutaneous melanoma by historical pathology report review, clinical Stage I-III (Cohort #1), or Stage IV (Cohort #2) cutaneous melanoma
  3. * At least one, biopsy-proven, palpable melanoma tumor deposit suitable for intralesional injection measuring ≥ 1 cm by digital caliper (with digital photography documentation) or ultrasound (with ultrasound image documentation)
  4. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
  1. * Known allergy or intolerance to influenza vaccination
  2. * Subjects with condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone/equivalent) or other immunosuppressive medications within 14 days of study drug administration
  3. * Active, known or suspected autoimmune disease
  4. * Active brain metastasis or leptomeningeal metastasis
  5. * Diagnostic biopsy of ocular or mucosal melanoma
  6. * Any melanoma therapy within 6 months of enrollment; though prior surgical resection is permitted
  7. * Incarcerated patients
  8. * Human immunodeficiency virus (HIV) positive patients
  9. * Pregnant or lactating patients
  10. * Patients incapable of independently providing consent

Contacts and Locations

Study Contact

The Ohio State University Comprehensive Cancer Center
CONTACT
800-293-5066
OSUCCCClinicaltrials@osumc.edu

Principal Investigator

Carlo M Contreras, MD
PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center

Study Locations (Sites)

Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
United States

Collaborators and Investigators

Sponsor: Carlo Contreras

  • Carlo M Contreras, MD, PRINCIPAL_INVESTIGATOR, Ohio State University Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-20
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2021-10-20
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Clinical Stage I Cutaneous Melanoma AJCC V8
  • Clinical Stage IA Cutaneous Melanoma AJCC V8
  • Clinical Stage IB Cutaneous Melanoma AJCC V8
  • Clinical Stage II Cutaneous Melanoma AJCC V8
  • Clinical Stage IIA Cutaneous Melanoma AJCC V8
  • Clinical Stage IIB Cutaneous Melanoma AJCC V8
  • Clinical Stage IIC Cutaneous Melanoma AJCC V8
  • Clinical Stage IV Cutaneous Melanoma AJCC V8
  • Metastatic Melanoma