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Nordic Adjuvant IFN Melanoma Trial

NCT ID: NCT01259934

Last Updated: 2010-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

855 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-11-30

Study Completion Date

2008-06-30

Brief Summary

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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

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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.

Conditions

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Melanoma Adjuvant Therapy

Keywords

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Randomized Phase III trial Adjuvant therapy Interferon Melanoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

Observation only - no therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

Interferon-alpha2b - 1 year

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

Interferon-alpha2b - 2 years

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Intron-A Intron-A

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Department of Oncology-Pathology, Karolinska Institutet

Principal Investigators

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Johan Hansson, MD,PhD

Role: STUDY_CHAIR

Karolinska Institutet

Steinar Aamdal, MD. PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital, Oslo, Norway

Lars Bastholt, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Micaela Hernberg, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital, Helsinki, Finland

Ulrika Stierner, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska University Hospital

Hans von der Maase, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Copenhagen University Hospital, Copenhagen, Denmark

Locations

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Karolinska Institutet, Karolinska University Hospital,

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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Bouwhuis MG, Suciu S, Collette S, Aamdal S, Kruit WH, Bastholt L, Stierner U, Sales F, Patel P, Punt CJ, Hernberg M, Spatz A, ten Hagen TL, Hansson J, Eggermont AM; EORTC Melanoma Group and the Nordic Melanoma Group. Autoimmune antibodies and recurrence-free interval in melanoma patients treated with adjuvant interferon. J Natl Cancer Inst. 2009 Jun 16;101(12):869-77. doi: 10.1093/jnci/djp132. Epub 2009 Jun 9.

Reference Type BACKGROUND
PMID: 19509353 (View on PubMed)

Prasmickaite L, Berge G, Bettum IJ, Aamdal S, Hansson J, Bastholt L, Oijordsbakken M, Boye K, Maelandsmo GM. Evaluation of serum osteopontin level and gene polymorphism as biomarkers: analyses from the Nordic Adjuvant Interferon alpha Melanoma trial. Cancer Immunol Immunother. 2015 Jun;64(6):769-76. doi: 10.1007/s00262-015-1686-4. Epub 2015 Apr 2.

Reference Type DERIVED
PMID: 25832001 (View on PubMed)

Hansson J, Aamdal S, Bastholt L, Brandberg Y, Hernberg M, Nilsson B, Stierner U, von der Maase H; Nordic Melanoma Cooperative Group. Two different durations of adjuvant therapy with intermediate-dose interferon alfa-2b in patients with high-risk melanoma (Nordic IFN trial): a randomised phase 3 trial. Lancet Oncol. 2011 Feb;12(2):144-52. doi: 10.1016/S1470-2045(10)70288-6. Epub 2011 Jan 20.

Reference Type DERIVED
PMID: 21256809 (View on PubMed)

Other Identifiers

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Nordic-IFN-melanoma trial

Identifier Type: -

Identifier Source: org_study_id