Nordic Adjuvant IFN Melanoma Trial

This study has been completed.

Sponsor:

Collaborator:

Merck

Information provided by:

Karolinska Institutet

ClinicalTrials.gov Identifier:

NCT01259934

First received: December 10, 2010

Last updated: December 13, 2010

Last verified: December 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

December 10, 2010

Last Updated Date

December 13, 2010

Start Date ^ICMJE

November 1996

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01259934 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Arm (s)

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

Enrollment ^ICMJE

855

Completion Date

June 2008

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Sweden

Administrative Information

NCT Number ^ICMJE

NCT01259934

Other Study ID Numbers ^ICMJE

Nordic-IFN-melanoma trial

Has Data Monitoring Committee

Yes

Responsible Party

Johan Hansson, PI, Department of Oncology-Pathology, Karolinska Institutet

Study Sponsor ^ICMJE

Karolinska Institutet

Collaborators ^ICMJE

Merck

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

Information Provided By

Karolinska Institutet

Verification Date

December 2010

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

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