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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00204581
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : August 19, 2011
Information provided by:
University Hospital Tuebingen

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 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.

Condition or disease Intervention/treatment Phase
Melanoma Drug: Interleukin-2 (Proleukin) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intralesional Treatment With Interleukin-2 (Proleukin) in Soft Tissue Melanoma Metastases. A Phase II, Prospective, Open, Multicenter Trial
Study Start Date : August 2003
Actual Primary Completion Date : January 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
Drug Information available for: Aldesleukin
U.S. FDA Resources

Intervention Details:
    Drug: Interleukin-2 (Proleukin)
    6-12 MIE/d 3times a week
    Other Name: Proleukin

Primary Outcome Measures :
  1. Efficacy in regard to complete and partial response [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: every 6 months ]
  2. Side-effects [ Time Frame: during treament and 4 weeks afterwards ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00204581

Skin Cancer Program, Department of Dermatology, Liebermeisterstrasse 8
Tübingen, BW, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
Principal Investigator: Claus Garbe, MD Skin Cancer Program, Department of Dermatology, University Hospital Tübingen

Additional Information:
Responsible Party: Skin Cancer Programme, Dept. of Dermatology Identifier: NCT00204581     History of Changes
Other Study ID Numbers: IL-2-LOK-MM
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: August 19, 2011
Last Verified: February 2009

Keywords provided by University Hospital Tuebingen:
Soft tissue metastases

Additional relevant MeSH terms:
Neoplasm Metastasis
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplastic Processes
Pathologic Processes
Antineoplastic Agents
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents