Intralesional Influenza Vaccine for the Treatment of Stage I-IV Melanoma (NCT04697576) | Clinical Trial Compass
RecruitingPhase 1
Intralesional Influenza Vaccine for the Treatment of Stage I-IV Melanoma
United States36 participantsStarted 2021-10-20
Plain-language summary
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.
Who can participate
Age range18 Years – 99 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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)
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 x upper limit of normal (ULN) or =\< 5 x ULN in patients with liver metastases (Cohort 2 only) (drawn at or not more than 30 days prior to the screening visit)
* Prothrombin time =\< 1.5 x ULN (drawn at or not more than 30 days prior to the screening visit)
* Total bilirubin =\< 1.5 x ULN (unconjugated bilirubin of \< 3 x ULN for patients with known Gilbert syndrome) (drawn at or not more than 30 days prior to the screening visit)
* Creatinine clearance of \>= 50 ml/min by Cockcroft-Gault equation (drawn at or not more than 30 days prior to the screening visit)
* Women of …
What they're measuring
1
Incidence of adverse events (AEs)
Timeframe: Up to 1 year after the last intra-tumoral dose
2
Maximum tolerated dose (MTD) in Cohorts #1 and #2
Timeframe: Up to 98 days
Trial details
NCT IDNCT04697576
SponsorCarlo Contreras
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2027-09-30
Contact for this trial
The Ohio State University Comprehensive Cancer Center