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Completed

NCT Number: NCT00204581

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

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.

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Skin Cancer Program, Department of Dermatology, Liebermeisterstrasse 8

Tübingen, Baden-Wurttemberg, 72076, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Interleukin-2 (Proleukin)

Drug

6-12 MIE/d 3times a week

Other names: Proleukin

Primary outcomes

  1. Efficacy in regard to complete and partial response

    Time frame: 4 weeks

Secondary outcomes

  1. Overall survival

    Time frame: every 6 months

  2. Side-effects

    Time frame: during treament and 4 weeks afterwards

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

Intralesional Treatment With Interleukin-2 (Proleukin) in Soft Tissue Melanoma Metastases. A Phase II, Prospective, Open, Multicenter Trial

Important dates

Study start
2003
Primary completion
2009
Study completion
2009
First posted
Sep 20, 2005
Registry last updated
Aug 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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