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)
Sponsored by
About this trial
This is an interventional treatment trial for Melanoma focused on measuring Melanoma, Soft tissue metastases, Interleukin-2
Eligibility 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)
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
No
Eligibility 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)
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
BW
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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