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

August 18, 2011 updated by: University Hospital Tuebingen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • BW
      • Tübingen, BW, Germany, 72076
        • Skin Cancer Program, Department of Dermatology, Liebermeisterstrasse 8

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Investigators

  • Principal Investigator: Claus Garbe, MD, Skin Cancer Program, Department of Dermatology, University Hospital Tübingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

August 19, 2011

Last Update Submitted That Met QC Criteria

August 18, 2011

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IL-2-LOK-MM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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