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

Information source: University Hospital Tuebingen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Melanoma

Intervention: Interleukin-2 (Proleukin) (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: University Hospital Tuebingen

Official(s) and/or principal investigator(s):
Claus Garbe, MD, Principal Investigator, Affiliation: Skin Cancer Program, Department of Dermatology, University Hospital Tübingen

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Efficacy in regard to complete and partial response

Secondary outcome:

Overall survival

Side-effects

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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)

Locations and Contacts

Skin Cancer Program, Department of Dermatology, Liebermeisterstrasse 8, Tübingen, BW 72076, Germany
Additional Information

Link to published abstract

Related 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.

Starting date: August 2003
Last updated: August 18, 2011

Page last updated: August 23, 2015

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