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
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    All registered deaths, not only melanoma-specific.


Secondary Outcome Measures:
  • 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


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01259934

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Johan Hansson, PI, Department of Oncology-Pathology, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01259934     History of Changes
Other Study ID Numbers: Nordic-IFN-melanoma trial
Study First Received: December 10, 2010
Last Updated: December 13, 2010
Health Authority: Sweden: Medical Products Agency
Denmark: Danish Medicines Agency
Norway: Norwegian Medicines Agency
Finland: Finnish Medicines Agency

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

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Interferon-alpha
Interferon Alfa-2a
Interferon Alfa-2b
Interferons
Reaferon
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Adjuvants, Immunologic
Alcohol Deterrents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 24, 2014