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Nordic Adjuvant IFN Melanoma Trial

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ClinicalTrials.gov Identifier: NCT01259934
Recruitment Status : Completed
First Posted : December 14, 2010
Last Update Posted : December 14, 2010
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Karolinska Institutet

Tracking Information
First Submitted Date  ICMJE December 10, 2010
First Posted Date  ICMJE December 14, 2010
Last Update Posted Date December 14, 2010
Study Start Date  ICMJE November 1996
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 13, 2010)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2010)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nordic Adjuvant IFN Melanoma Trial
Official Title  ICMJE Nordic Randomized Phase III Trial of Two Different Durations of Adjuvant Therapy With Intermediate-dose Interferon Alfa-2b in Patients With High-risk Melanoma
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Melanoma
  • Adjuvant Therapy
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 13, 2010)
855
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01259934
Other Study ID Numbers  ICMJE Nordic-IFN-melanoma trial
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johan Hansson, PI, Department of Oncology-Pathology, Karolinska Institutet
Study Sponsor  ICMJE Karolinska Institutet
Collaborators  ICMJE Merck Sharp & Dohme Corp.
Investigators  ICMJE
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
PRS Account Karolinska Institutet
Verification Date December 2010

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