Intralesional Treatment With Interleukin-2 (Proleukin) in Soft Tissue Melanoma Metastases
Phase 2
Completed
- Conditions
- Melanoma
- Registration Number
- NCT00204581
- Lead Sponsor
- University Hospital Tuebingen
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Efficacy in regard to complete and partial response 4 weeks
- Secondary Outcome Measures
Name Time Method Overall survival every 6 months Side-effects during treament and 4 weeks afterwards
Trial Locations
- Locations (1)
Skin Cancer Program, Department of Dermatology, Liebermeisterstrasse 8
🇩🇪Tübingen, BW, Germany