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

NCT00204581 | Completed Phase 2

• 1 other identifier: IL-2-LOK-MM
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma

Keywords

Melanoma; Soft tissue metastases; Interleukin-2

Outcome Measures

Primary Outcomes (1)

• Efficacy in regard to complete and partial response

  4 weeks

Secondary Outcomes (2)

• Overall survival

  every 6 months

• Side-effects

  during treament and 4 weeks afterwards

Interventions

Interleukin-2 (Proleukin) DRUG

6-12 MIE/d 3times a week

Also known as: Proleukin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18+
• Informed consent
• Histologically proven melanoma
• Have confirmed stage IIIB or stage IV disease (AJCC 2002) with skin or soft-tissue metastases

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

Skin Cancer Program, Department of Dermatology, Liebermeisterstrasse 8

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Related Publications (1)

• 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. doi: 10.1038/sj.bjc.6601320.

  PMID: 14583759 BACKGROUND

Related Links

• Link to published abstract

MeSH Terms

Conditions

Melanoma

Interventions

Interleukin-2; aldesleukin

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Study Officials

• Claus Garbe, MD

  Skin Cancer Program, Department of Dermatology, University Hospital Tübingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: August 1, 2003
• Primary Completion: January 1, 2009
• Study Completion: December 1, 2009
• Last Updated: August 19, 2011

Record last verified: 2009-02

Locations

DE (1)