Melanoma
Conditions
Keywords
Melanoma, Soft tissue metastases, Interleukin-2
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.
Interventions
DRUGInterleukin-2 (Proleukin)
6-12 MIE/d 3times a week
Sponsors
University Hospital Tuebingen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy in regard to complete and partial response | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | every 6 months |
| Side-effects | during treament and 4 weeks afterwards |
Countries
Germany
Outcome results
None listed