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

Sponsor

University Hospital Tuebingen (Other)

Overall Status

Completed

CT.gov ID

NCT00204581

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Melanoma	Drug: Interleukin-2 (Proleukin)	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

51 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2003

Actual Primary Completion Date :

Jan 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Outcome Measures

Primary Outcome Measures

Efficacy in regard to complete and partial response [4 weeks]

Secondary Outcome Measures

Overall survival [every 6 months]
Side-effects [during treament and 4 weeks afterwards]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)