Trial | NCT01259934  Report issue

Title

Nordic Adjuvant IFN Melanoma Trial
Nordic Randomized Phase III Trial of Two Different Durations of Adjuvant Therapy With Intermediate-dose Interferon Alfa-2b in Patients With High-risk Melanoma

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Indication/Condition

    Melanoma ...

  • Intervention/Treatment

    interferon alpha-2b ...

  • Study Participants

    855
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.
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 Started
Nov 30
1996
Primary Completion
Jun 30
2008
Study Completion
Jun 30
2008
Last Update
Dec 14
2010
Estimate

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 names: 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 names: Intron-A

Arm A No Intervention

Observation only - no therapy

Arm B Interferon 1 year Experimental

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

Arm C Interferon 2 years Experimental

"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

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
No Results Posted