Electrochemotherapy versus narrow excision margins for high-risk, primary cutaneous melanoma

Phase 1

• Conditions: primary cutaneous melanoma; MedDRA version: 20.0Level: LLTClassification code 10027155Term: Melanoma skinSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-003531-30-IT
• Lead Sponsor: ISTITUTO NAZIONALE TUMORI - IRCCS FONDAZIONE PASCALE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-20
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

Age = 18 years
Histologically confirmed diagnosis of cutaneous melanoma
Stage of disease: single, primary, localized cutaneous melanoma 2 mm or greater in thickness Breslow on the trunk or limbs (excluding soles of the feet)
Performance status (PS) according to The Eastern Cooperative Oncology Group (ECOG) = 2
Written informed consent
Use of an acceptable mean of contraception for men and women of childbearing potential
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

•Diagnosis of mestastatic melanoma.
•Serious coagulation abnormality, INR above 1.5
•Absolute neutrophil count below 1,000/ml
•Platelet count below 70,000/ml
•Hemoglobin = 9 gr/dl
•Known allergies to Bleomycin
•Cumulative lifetime dose of Bleomycin exceeding 250 mg/m2
•Peripheral neuropathy greater than grade 2
•Chronic renal deficiency (creatinine>1.5 µg/L)
•Active infection
•Cardiac arrhythmias [e.g., significant ventricular arrhythmia such as persistent ventricular tachycardia and/or ventricular fibrillation; severe conduction disorders as atrioventricular block 2 and 3, sinoatrial block]
•Epilepsy
•Pregnant or breastfeeding
•Any other cancer from which the patients had been disease free for less than 5 years (except treated and cured basal–cell or squamous-cell skin cancer, superficial bladder cancer, or treated carcinoma in situ of the cervix, breast, or bladder)
•Pulmonary infection
•Severely impaired lung function

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified