Nordic Adjuvant IFN Melanoma Trial

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to evaluate the effect of giving adjuvant treatment with intermediate doses of interferon-alpha2b to patients operated for high risk melanoma. Patients are randomly assigned to either observation only or interferon treatment for 2 different durations. The outcome with respect to overall survival, relapse-free survival, side effects and quality of life is analysed.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Karolinska Institutet
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons

Criteria

Inclusion Criteria:

• T4 N0 M0 - Thick primary melanoma: > 4.0 mm Breslow depth, without lymph node involvement, or

• Tx N1-2 M0 Primary melanoma of any thickness with regional lymph node metastases confirmed by lymphadenectomy, or

• Tx N1-2 M0 Recurrent melanoma in regional lymph node(s) confirmed by lymphadenectomy.

• ECOG performance status of 0-1

• No active medical or psychiatric disorder requiring therapy that would prevent completion of protocol

• Written informed consent

Exclusion Criteria:

• Patients with unknown primary site of melanoma or primary melanoma originating apart from the skin, except subungual melanoma

• Patients who have clinical, radiological/laboratory or pathological evidence of incompletely resected melanoma or distant metastatic disease

• Patients who have had prior adjuvant radiotherapy, chemotherapy, immunotherapy including preoperative infusion or perfusion therapy

• Female patients who are pregnant or lactating