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Nordic Adjuvant IFN Melanoma Trial

Primary Purpose

Melanoma, Adjuvant Therapy

Status

Completed

Phase

Phase 3

Locations

Sweden

Study Type

Interventional

Intervention

Interferon-alpha2b - 1 year

Interferon-alpha2b - 2 years

About this trial

This is an interventional treatment trial for Melanoma focused on measuring Randomized Phase III trial, Adjuvant therapy, Interferon, Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Karolinska Institutet, Karolinska University Hospital,

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Arm Label

Arm A

Arm B Interferon 1 year

Arm C Interferon 2 years

Arm Description

Observation only - no therapy

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

"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

Outcomes

Primary Outcome Measures

Overall survival

All registered deaths, not only melanoma-specific.

Secondary Outcome Measures

Relapse free survival

Time from randomization to date of first reported melanoma recurrence or death

Safety-toxicity

All toxicities and SAEs are recorded and classified according to CTC v2.0 criteria

Health related quality of life

Recorded by using the EORTC QLQ-C30 questionnaire at nine time points during treatment and follow-up

Full Information

NCT ID

NCT01259934

First Posted

December 10, 2010

Last Updated

December 13, 2010

Sponsor

Karolinska Institutet

Collaborators

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT01259934

Brief Title

Nordic Adjuvant IFN Melanoma 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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2010

Overall Recruitment Status

Completed

Study Start Date

November 1996 (undefined)

Primary Completion Date

June 2008 (Actual)

Study Completion Date

June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Karolinska Institutet

Collaborators

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melanoma, Adjuvant Therapy

Keywords

Randomized Phase III trial, Adjuvant therapy, Interferon, Melanoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

855 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

No Intervention

Arm Description

Observation only - no therapy

Arm Title

Arm B Interferon 1 year

Arm Type

Experimental

Arm Description

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 Title

Arm C Interferon 2 years

Arm Type

Experimental

Arm Description

"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 Type

Drug

Intervention Name(s)

Interferon-alpha2b - 1 year

Other Intervention Name(s)

Intron-A

Intervention Description

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

Intervention Name(s)

Interferon-alpha2b - 2 years

Other Intervention Name(s)

Intron-A

Intervention Description

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

Primary Outcome Measure Information:

Title

Overall survival

Description

All registered deaths, not only melanoma-specific.

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

Secondary Outcome Measure Information:

Title

Relapse free survival

Description

Time from randomization to date of first reported melanoma recurrence or death

Time Frame

Evaluated at regular intervals

Title

Safety-toxicity

Description

All toxicities and SAEs are recorded and classified according to CTC v2.0 criteria

Time Frame

Regular evaluations

Title

Health related quality of life

Description

Recorded by using the EORTC QLQ-C30 questionnaire at nine time points during treatment and follow-up

Time Frame

Regular evaluations

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials: