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

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Tuebingen
• Treatments: Aldesleukin; Interleukin-2

Criteria

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)