Intralesional Treatment With Interleukin-2 (Proleukin) in Soft Tissue Melanoma Metastases

Intralesional Treatment With Interleukin-2 (Proleukin) in Soft Tissue Melanoma Metastases. A Phase II, Prospective, Open, Multicenter Trial

The intra-/perilesional application of interleukin-2 seems to be a safe and effective treatment of skin and soft tissue metastases in malignant melanoma. Especially in case of intransit metastases the overall survival rate is still 20-30%.

However, the management of intransit metastases is sometimes difficult because of frequent recurrences. IL-2 intralesionally seems to be an non-invasive option as pilot studies indicate. In this study the safety and efficacy of IL-2 are evaluated.

Inclusion Criteria:

• Age 18+
• Informed consent
• Histologically proven melanoma
• Have confirmed stage IIIB or stage IV disease (AJCC 2002) with skin or soft-tissue metastases

Exclusion Criteria:

• Pregnant or lactating women
• Patients with severe cardiac disease (e.g. NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina)
• Patients with severe liver disease or severe renal disease
• Simultaneous immunosuppressive treatment (e.g. steroids)
• Simultaneous chemotherapy
• Pretreated soft-tissue or skin metastases (e.g. cryo-, radiotherapy)