Nordic Adjuvant IFN Melanoma Trial

Karolinska Institute

Status and phase: Completed; Phase 3

Conditions: Melanoma; Adjuvant Therapy

Treatments: Drug: Interferon-alpha2b - 1 year; Drug: Interferon-alpha2b - 2 years

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01259934

Nordic-IFN-melanoma trial

Details and patient eligibility

About

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.

Full description

This is an open multicenter, prospective randomised phase III trial evaluating the efficacy of two different schedules of Interferon-alpha2b (IFN-alpha2b) administered in an adjuvant setting after adequate surgery in high risk cutaneous melanoma patients (T4N0M0/TxN1-2M0). The patients have been operated for either a thick primary melanoma (> 4 mm) without evidence of distant metastasis or have undergone surgery for regional lymph node metastases.

The study consists of a control arm (A) and two treatment arms, B and C. The outcome in arms B and C with adjuvant treatment with IFN-alpha2b will be compared to the outcome of arm A in which the patients will only be observed after the surgery. The primary endpoint is overall survival. Secondary endpoints are relapse-free survival, safety-toxicity and health-related quality of life.

Enrollment: 855 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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855 participants in 3 patient groups

Arm A

No Intervention group

Description:

Observation only - no therapy

Arm B Interferon 1 year

Experimental group

Description:

Interferon Therapy: Induction: IFN-alfa2b, 10 MU (flat dose), SC, 5 days/week, 4 weeks Maintenance: IFN-alfa2b, 10 MU (flat dose), 3 days/week, SC, 12 months

Treatment:

Drug: Interferon-alpha2b - 1 year

Arm C Interferon 2 years

Experimental group

Description:

"Two year arm" Induction: IFN-alfa2b, 10 MU (flat dose), SC, 5 days/week, 4 weeks Maintenance: IFN-alfa2b, 10 MU (flat dose), 3 days/week, SC, 24 months

Treatment:

Drug: Interferon-alpha2b - 2 years