Trial Information
Intralesional Treatment With Interleukin-2 (Proleukin) in Soft Tissue Melanoma Metastases. A Phase II, Prospective, Open, Multicenter Trial
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)
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Efficacy in regard to complete and partial response
Outcome Time Frame:
4 weeks
Safety Issue:
No
Principal Investigator
Claus Garbe, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Skin Cancer Program, Department of Dermatology, University Hospital Tübingen
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
IL-2-LOK-MM
NCT ID:
NCT00204581
Start Date:
August 2003
Completion Date:
December 2009
Related Keywords:
- Melanoma
- Melanoma
- Soft tissue metastases
- Interleukin-2
- Melanoma
- Neoplasm Metastasis