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

Overview

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.

Full Title of Study: “Intralesional Treatment With Interleukin-2 (Proleukin) in Soft Tissue Melanoma Metastases. A Phase II, Prospective, Open, Multicenter Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2009

Interventions

  • Drug: Interleukin-2 (Proleukin)
    • 6-12 MIE/d 3times a week

Clinical Trial Outcome Measures

Primary Measures

  • Efficacy in regard to complete and partial response
    • Time Frame: 4 weeks

Secondary Measures

  • Overall survival
    • Time Frame: every 6 months
  • Side-effects
    • Time Frame: during treament and 4 weeks afterwards

Participating in This Clinical 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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital Tuebingen
  • Provider of Information About this Clinical Study
    • Skin Cancer Programme, Dept. of Dermatology
  • Overall Official(s)
    • Claus Garbe, MD, Principal Investigator, Skin Cancer Program, Department of Dermatology, University Hospital Tübingen

References

Radny P, Caroli UM, Bauer J, Paul T, Schlegel C, Eigentler TK, Weide B, Schwarz M, Garbe C. Phase II trial of intralesional therapy with interleukin-2 in soft-tissue melanoma metastases. Br J Cancer. 2003 Nov 3;89(9):1620-6. doi: 10.1038/sj.bjc.6601320.

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