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Nordic Adjuvant IFN Melanoma Trial

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01259934
First received: December 10, 2010
Last updated: December 13, 2010
Last verified: December 2010

December 10, 2010
December 13, 2010
November 1996
June 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
All registered deaths, not only melanoma-specific.
Same as current
Complete list of historical versions of study NCT01259934 on ClinicalTrials.gov Archive Site
  • Relapse free survival [ Time Frame: Evaluated at regular intervals ] [ Designated as safety issue: No ]
    Time from randomization to date of first reported melanoma recurrence or death
  • Safety-toxicity [ Time Frame: Regular evaluations ] [ Designated as safety issue: Yes ]
    All toxicities and SAEs are recorded and classified according to CTC v2.0 criteria
  • Health related quality of life [ Time Frame: Regular evaluations ] [ Designated as safety issue: Yes ]
    Recorded by using the EORTC QLQ-C30 questionnaire at nine time points during treatment and follow-up
Same as current
Not Provided
Not Provided
 
Nordic Adjuvant IFN Melanoma Trial
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Melanoma
  • Adjuvant Therapy
  • 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
  • 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
  • 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
    Intervention: Drug: Interferon-alpha2b - 1 year
  • 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
    Intervention: Drug: Interferon-alpha2b - 2 years

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
855
June 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01259934
Nordic-IFN-melanoma trial
Yes
Johan Hansson, PI, Department of Oncology-Pathology, Karolinska Institutet
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
Karolinska Institutet
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP