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

This study has been completed.
Sponsor:
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00204581
First received: September 13, 2005
Last updated: August 18, 2011
Last verified: February 2009
  Purpose

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 Intervention Phase
Melanoma
Drug: Interleukin-2 (Proleukin)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • Efficacy in regard to complete and partial response [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
  • Side-effects [ Time Frame: during treament and 4 weeks afterwards ] [ Designated as safety issue: Yes ]

Enrollment: 51
Study Start Date: August 2003
Study Completion Date: December 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Interleukin-2 (Proleukin)
    6-12 MIE/d 3times a week
    Other Name: Proleukin
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: September 13, 2005
Last Updated: August 18, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on August 26, 2014