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

University Hospital Tuebingen

Status and phase

Completed

Phase 2

Conditions

Melanoma

Treatments

Drug: Interleukin-2 (Proleukin)

Study type

Interventional

Funder types

Other

Identifiers

NCT00204581

IL-2-LOK-MM

Details and patient eligibility

About

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.

Enrollment

51 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)