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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.
ClinicalTrials.gov Identifier: NCT00204581
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : August 19, 2011
Sponsor:
Information provided by:

Study Description
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 Design

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
Primary Completion Date : January 2009
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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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

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)
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00204581


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

Additional Information:
Publications:
Responsible Party: Skin Cancer Programme, Dept. of Dermatology
ClinicalTrials.gov 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:
Melanoma
Soft tissue metastases
Interleukin-2

Additional relevant MeSH terms:
Melanoma
Neoplasm Metastasis
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplastic Processes
Pathologic Processes
Aldesleukin
Interleukin-2
Antineoplastic Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents