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

This study is currently recruiting participants.

Verified by University Hospital Tuebingen, April 2007

Sponsored by:	University Hospital Tuebingen
Information provided by:	University Hospital Tuebingen
ClinicalTrials.gov Identifier:	NCT00204581

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 intransite metastases the overall survival rate is still 20-30%.

However, the management of intransite 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 II

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Aldesleukin Interleukin-2

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Intralesional Treatment With Interleukin-2 (Proleukin) in Soft Tissue Melanoma Metastases. A Phase II, Prospective, Open, Multicenter Trial

Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:

Efficacy in regard to complete and partial response

Secondary Outcome Measures:

Overall survival
Side-effects

Estimated Enrollment:	50
Study Start Date:	August 2003
Estimated Study Completion Date:	April 2007

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 tachyarrythmias 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00204581

Contacts

Contact: Claus Garbe, MD

++49 7071 29 87110

claus.garbe@med.uni-tuebingen.de

Locations

Germany, BW
Skin Cancer Program, Department of Dermatology, Liebermeisterstrasse 8	Recruiting
Tübingen, BW, Germany, 72076
Contact: Claus Garbe, MD ++49 7071 29 87110 claus.garbe@med.uni-tuebingen.de
Principal Investigator: Claus Garbe, MD
Sub-Investigator: Benjamin Weide, MD
Sub-Investigator: Thomas Eigentler, MD

Sponsors and Collaborators

University Hospital Tuebingen

Investigators

Principal Investigator:

Claus Garbe, MD

Skin Cancer Program, Department of Dermatology, University Hospital Tübingen

More Information

Publications:

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.

Study ID Numbers:	IL-2-LOK-MM
Study First Received:	September 13, 2005
Last Updated:	April 18, 2007
ClinicalTrials.gov Identifier:	NCT00204581
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Tuebingen:

Melanoma
Soft tissue metastases
Interleukin-2

Study placed in the following topic categories:

Neuroectodermal Tumors
Aldesleukin
Interleukin-2
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal

Neoplasm Metastasis
Neuroepithelioma
Nevus
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-HIV Agents
Neoplasms by Histologic Type
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplastic Processes

Pathologic Processes
Anti-Retroviral Agents
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Nevi and Melanomas
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009