RECRUITING

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

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.

Conditions

Clinical Stage I Cutaneous Melanoma AJCC V8Clinical Stage IA Cutaneous Melanoma AJCC V8Clinical Stage IB Cutaneous Melanoma AJCC V8Clinical Stage II Cutaneous Melanoma AJCC V8Clinical Stage IIA Cutaneous Melanoma AJCC V8Clinical Stage IIB Cutaneous Melanoma AJCC V8Clinical Stage IIC Cutaneous Melanoma AJCC V8Clinical Stage IV Cutaneous Melanoma AJCC V8Metastatic Melanoma
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Related Conditions:

Clinical Stage I Cutaneous Melanoma AJCC V8Clinical Stage IA Cutaneous Melanoma AJCC V8Clinical Stage IB Cutaneous Melanoma AJCC V8Clinical Stage II Cutaneous Melanoma AJCC V8Clinical Stage IIA Cutaneous Melanoma AJCC V8Clinical Stage IIB Cutaneous Melanoma AJCC V8Clinical Stage IIC Cutaneous Melanoma AJCC V8Clinical Stage IV Cutaneous Melanoma AJCC V8Metastatic Melanoma

Study Overview

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Study Details

Study overview

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.

Intralesional Influenza Vaccine for Patients with Melanoma

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

Condition
Clinical Stage I Cutaneous Melanoma AJCC V8
Intervention / Treatment

-

Contacts and Locations

Columbus

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 18 to 99 years of age
  • * Histologically confirmed cutaneous melanoma by historical pathology report review, clinical Stage I-III (Cohort #1), or Stage IV (Cohort #2) cutaneous melanoma
  • * 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)
  • * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
  • * Known allergy or intolerance to influenza vaccination
  • * 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
  • * Active, known or suspected autoimmune disease
  • * Active brain metastasis or leptomeningeal metastasis
  • * Diagnostic biopsy of ocular or mucosal melanoma
  • * Any melanoma therapy within 6 months of enrollment; though prior surgical resection is permitted
  • * Incarcerated patients
  • * Human immunodeficiency virus (HIV) positive patients
  • * Pregnant or lactating patients
  • * Patients incapable of independently providing consent

Ages Eligible for Study

18 Years to 99 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Carlo Contreras,

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

Study Record Dates

2026-12-31