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


Phase 2
18 Years
N/A
Not Enrolling
Both
Melanoma

Thank you

Trial Information

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


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)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Efficacy in regard to complete and partial response

Outcome Time Frame:

4 weeks

Safety Issue:

No

Principal Investigator

Claus Garbe, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Skin Cancer Program, Department of Dermatology, University Hospital Tübingen

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

IL-2-LOK-MM

NCT ID:

NCT00204581

Start Date:

August 2003

Completion Date:

December 2009

Related Keywords:

  • Melanoma
  • Melanoma
  • Soft tissue metastases
  • Interleukin-2
  • Melanoma
  • Neoplasm Metastasis

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