Nordic Adjuvant IFN Melanoma Trial

Phase 3

Completed

• Conditions: Melanoma; Adjuvant Therapy
• Interventions: Drug: Interferon-alpha2b - 1 year; Drug: Interferon-alpha2b - 2 years

• Registration Number: NCT01259934
• Lead Sponsor: Karolinska Institutet

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 1996-11
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Status Verified: 2010-12
• Study First Submitted: 2010-12-10
• Study First Submitted QC: 2010-12-13
• Last Update Submitted: 2010-12-13
• Study First Posted: 2010-12-14
• Last Update Posted: 2010-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 855

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B Interferon 1 year	Interferon-alpha2b - 1 year	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
Arm C Interferon 2 years	Interferon-alpha2b - 2 years	"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

Primary Outcome Measures

Name	Time	Method
Overall survival	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	All registered deaths, not only melanoma-specific.

Secondary Outcome Measures

Name	Time	Method
Relapse free survival	Evaluated at regular intervals	Time from randomization to date of first reported melanoma recurrence or death
Safety-toxicity	Regular evaluations	All toxicities and SAEs are recorded and classified according to CTC v2.0 criteria
Health related quality of life	Regular evaluations	Recorded by using the EORTC QLQ-C30 questionnaire at nine time points during treatment and follow-up

Trial Locations

Locations (1)

Karolinska Institutet, Karolinska University Hospital,; 🇸🇪 Stockholm, Sweden