Nordic Adjuvant IFN Melanoma Trial

Karolinska Institutet855 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

855

Conditions

Melanoma Adjuvant Therapy

Interventions

Interferon-alpha2b - 1 yearDRUG

Induction: IFN-alpha2b, 10 MU (flat dose), SC, 5 days/week, 4 weeks Maintenance: IFN-alpha2b, 10 MU (flat dose), 3 days/week, SC, 12 months

Interferon-alpha2b - 2 yearsDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Karolinska Institutet, Karolinska University Hospital,

Stockholm, Sweden

Outcomes

Primary Outcomes

Overall survival

All registered deaths, not only melanoma-specific.

Time frame: Evaluated at regular intervals: every 3 months for 2 years, every 6 months up to 5 years and yearly up to 10 years following randomization. Actual median follow-up is 72.4 months

Secondary Outcomes

Relapse free survival

Time from randomization to date of first reported melanoma recurrence or death

Time frame: Evaluated at regular intervals

Safety-toxicity

All toxicities and SAEs are recorded and classified according to CTC v2.0 criteria

Time frame: Regular evaluations

Health related quality of life

Recorded by using the EORTC QLQ-C30 questionnaire at nine time points during treatment and follow-up

Time frame: Regular evaluations

Data from ClinicalTrials.gov

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