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

Primary Purpose

Melanoma

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Interleukin-2 (Proleukin)

About this trial

This is an interventional treatment trial for Melanoma focused on measuring Melanoma, Soft tissue metastases, Interleukin-2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Skin Cancer Program, Department of Dermatology, Liebermeisterstrasse 8

Outcomes

Primary Outcome Measures

Efficacy in regard to complete and partial response

Secondary Outcome Measures

Overall survival

Side-effects

Full Information

NCT ID

NCT00204581

First Posted

September 13, 2005

Last Updated

August 18, 2011

Sponsor

University Hospital Tuebingen

1. Study Identification

Unique Protocol Identification Number

NCT00204581

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Completed

Study Start Date

August 2003 (undefined)

Primary Completion Date

January 2009 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital Tuebingen

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melanoma

Keywords

Melanoma, Soft tissue metastases, Interleukin-2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Interleukin-2 (Proleukin)

Other Intervention Name(s)

Proleukin

Intervention Description

6-12 MIE/d 3times a week

Primary Outcome Measure Information:

Title

Efficacy in regard to complete and partial response

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Overall survival

Time Frame

every 6 months

Title

Side-effects

Time Frame

during treament and 4 weeks afterwards

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Claus Garbe, MD

Organizational Affiliation

Skin Cancer Program, Department of Dermatology, University Hospital Tübingen

Official's Role

Principal Investigator

Facility Information:

Facility Name

Skin Cancer Program, Department of Dermatology, Liebermeisterstrasse 8

City

Tübingen

State/Province

ZIP/Postal Code

72076

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

14583759

Citation

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.

Results Reference

background

Links:

URL

http://www.ncbi.nlm.nih.gov/pubmed/20564107

Description

Link to published abstract

Learn more about this trial

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

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