Status:
COMPLETED
Intralesional Treatment With Interleukin-2 (Proleukin) in Soft Tissue Melanoma Metastases
Lead Sponsor:
University Hospital Tuebingen
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- Age 18+
- Informed consent
- Histologically proven melanoma
- Have confirmed stage IIIB or stage IV disease (AJCC 2002) with skin or soft-tissue metastases
Exclusion
- 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)
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00204581
Start Date
August 1 2003
End Date
December 1 2009
Last Update
August 19 2011
Active Locations (1)
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1
Skin Cancer Program, Department of Dermatology, Liebermeisterstrasse 8
Tübingen, Baden-Wurttemberg, Germany, 72076