RecruitingClinical Stage I Cutaneous Melanoma AJCC v8Clinical Stage IA Cutaneous Melanoma AJCC v8Clinical Stage IB Cutaneous Melanoma AJCC v8
Intralesional Influenza Vaccine for the Treatment of Stage I-IV Melanoma
Eligible age
18–99 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Carlo Contreras
You may qualify if…
- ✓ Males or females
- ✓ 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
- ✓ Absolute neutrophil count (ANC) \>= 1.5 x 10\^3/mm\^3 (drawn at or not more than 30 days prior to the screening visit)
- ✓ Hemoglobin (Hgb) \>= 9 g/dL (drawn at or not more than 30 days prior to the screening visit)
- ✓ Platelet count \>= 100 x 10\^3/mm\^3 (drawn at or not more than 30 days prior to the screening visit)
You may not qualify if…
- ✕ 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
- ✕ Patients known to be HIV positive are eligible if they meet the following criteria within 30 days prior to randomization: stable and adequate CD4 counts (≥ 350 mm\^3), and serum HIV viral load of \< 25,000 IU/ml. Patients may be on or off anti-viral therapy so long as they meet the CD4 count criteria
Where it's recruiting
Ohio
Columbus
Source: ClinicalTrials.gov · NCT04697576 · last updated 2026-03-10