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Clinical Trials/NCT00204581
NCT00204581CompletedPhase 2

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

University Hospital Tuebingen2 sites in 1 country51 target enrollmentStarted: August 1, 2003Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
51
Locations
2
Primary Endpoint
Efficacy in regard to complete and partial response
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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)

Outcomes

Primary Outcomes

Efficacy in regard to complete and partial response

Time Frame: 4 weeks

Secondary Outcomes

  • Overall survival(every 6 months)
  • Side-effects(during treament and 4 weeks afterwards)

Investigators

Sponsor Class
Other

Study Sites (2)

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