Nordic Adjuvant IFN Melanoma Trial

Melanoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01259934
• Other study ID #: Nordic-IFN-melanoma trial
• Status: Completed
• Phase: Phase 3
• First received: December 10, 2010
• Last updated: December 13, 2010
• Start date: November 1996
• Est. completion date: June 2008

Study information

• Verified date: December 2010
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencyDenmark: Danish Medicines AgencyNorway: Norwegian Medicines AgencyFinland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 855
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adjuvant Therapy
• Melanoma

Intervention

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
• 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

Locations

Country	Name	City	State
Sweden	Karolinska Institutet, Karolinska University Hospital,	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Bouwhuis MG, Suciu S, Collette S, Aamdal S, Kruit WH, Bastholt L, Stierner U, Salès 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	All registered deaths, not only melanoma-specific.	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	No
Secondary	Relapse free survival	Time from randomization to date of first reported melanoma recurrence or death	Evaluated at regular intervals	No
Secondary	Safety-toxicity	All toxicities and SAEs are recorded and classified according to CTC v2.0 criteria	Regular evaluations	Yes
Secondary	Health related quality of life	Recorded by using the EORTC QLQ-C30 questionnaire at nine time points during treatment and follow-up	Regular evaluations	Yes

External Links

•   Study protocol (PDF)