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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Study Completion Date

2009-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Melanoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Interleukin-2 (Proleukin)

6-12 MIE/d 3times a week

Intervention Type DRUG

Other Intervention Names

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Proleukin

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No