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Nordic Adjuvant IFN Melanoma Trial

This study has been completed.
Merck Sharp & Dohme Corp.
Information provided by:
Karolinska Institutet Identifier:
First received: December 10, 2010
Last updated: December 13, 2010
Last verified: December 2010
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.

Condition Intervention Phase
Melanoma Adjuvant Therapy Drug: Interferon-alpha2b - 1 year Drug: Interferon-alpha2b - 2 years Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nordic Randomized Phase III Trial of Two Different Durations of Adjuvant Therapy With Intermediate-dose Interferon Alfa-2b in Patients With High-risk Melanoma

Resource links provided by NLM:

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • Relapse free survival [ Time Frame: Evaluated at regular intervals ]
    Time from randomization to date of first reported melanoma recurrence or death

  • Safety-toxicity [ Time Frame: Regular evaluations ]
    All toxicities and SAEs are recorded and classified according to CTC v2.0 criteria

  • 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

Enrollment: 855
Study Start Date: November 1996
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Intron-A

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01259934

Karolinska Institutet, Karolinska University Hospital,
Stockholm, Sweden, S-171 76
Sponsors and Collaborators
Karolinska Institutet
Merck Sharp & Dohme Corp.
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, Odense, Denmark
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
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Johan Hansson, PI, Department of Oncology-Pathology, Karolinska Institutet Identifier: NCT01259934     History of Changes
Other Study ID Numbers: Nordic-IFN-melanoma trial
Study First Received: December 10, 2010
Last Updated: December 13, 2010

Keywords provided by Karolinska Institutet:
Randomized Phase III trial
Adjuvant therapy

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on August 17, 2017