Nordic Adjuvant IFN Melanoma Trial

December 13, 2010 updated by: Karolinska Institutet

Nordic Randomized Phase III Trial of Two Different Durations of Adjuvant Therapy With Intermediate-dose Interferon Alfa-2b in Patients With High-risk Melanoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

855

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, S-171 76
        • Karolinska Institutet, Karolinska University Hospital,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Arm A
Observation only - no therapy
EXPERIMENTAL: Arm B Interferon 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
Drug: Interferon-alpha2b - 1 year
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
Other Names:
  • Intron-A
EXPERIMENTAL: Arm C Interferon 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
Drug: Interferon-alpha2b - 2 years
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
Other Names:
  • Intron-A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
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
All registered deaths, not only melanoma-specific.
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 Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Study Chair: Johan Hansson, MD,PhD, Karolinska Institutet, Stockholm, Sweden
  • Principal Investigator: Steinar Aamdal, MD. PhD, Oslo University Hospital, Oslo, Norway
  • Principal Investigator: Lars Bastholt, MD,PhD, Odense University Hospital
  • Principal Investigator: Micaela Hernberg, MD, PhD, Helsinki University Central Hospital, Helsinki, Finland
  • Principal Investigator: Ulrika Stierner, MD PhD, Sahlgrenska University Hospital, Gothenburg, Sweden
  • Principal Investigator: Hans von der Maase, MD PhD, Copenhagen University Hospital, Copenhagen, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 1996

Primary Completion (ACTUAL)

June 1, 2008

Study Completion (ACTUAL)

June 1, 2008

Study Registration Dates

First Submitted

December 10, 2010

First Submitted That Met QC Criteria

December 13, 2010

First Posted (ESTIMATE)

December 14, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

December 14, 2010

Last Update Submitted That Met QC Criteria

December 13, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nordic-IFN-melanoma trial

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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