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Interferon Alfa Following Surgery in Treating Patients With Stage III Melanoma

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ClinicalTrials.gov Identifier: NCT00006249
Recruitment Status : Unknown
Verified February 2015 by European Organisation for Research and Treatment of Cancer - EORTC.
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : February 10, 2015
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary:

RATIONALE: Interferon alfa may interfere with the growth of the cancer cells. It is not yet known if this treatment is more effective than observation following surgery for stage III melanoma.

PURPOSE: Randomized phase III trial to determine the effectiveness of interferon alfa in treating patients who have undergone surgery for stage III melanoma.

Condition or disease Intervention/treatment Phase
Melanoma (Skin) Biological: pegylated interferon alfa Procedure: adjuvant therapy Phase 3

Detailed Description:


  • Compare the effect of adjuvant therapy with pegylated interferon alfa vs observation, in terms of distant metastases-free survival, in patients with previously resected stage III melanoma.
  • Compare the overall survival in these patients after treatment with pegylated interferon alfa vs observation.
  • Determine the toxicity of pegylated interferon alfa in these patients.
  • Determine the compliance of these patients treated with pegylated interferon alfa.
  • Compare the quality of life in these patients after treatment with pegylated interferon alfa vs observation.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to type of nodal involvement (N1 vs N2), number of positive nodes (1 vs 2-4 vs 5 or more vs not assessed), Breslow primary (T1-2 vs T3 vs T4 vs unknown), ulceration of primary tumor (absent vs present vs unknown), sex, and center. Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive pegylated interferon alfa subcutaneously weekly for 5 years.
  • Arm II: Patients undergo observation only. Treatment continues in the absence of distant metastases or unacceptable toxicity.

Quality of life is assessed at baseline, and then at months 3, 12, 24, 36, 48, and 60.

Patients are followed every 6 months for 5 years.

PROJECTED ACCRUAL: A total of 1,200 patients (600 per treatment arm) will be accrued for this study within 1.5-2 years.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1258 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PEG-Intron Observation After Regional Lymph Node Dissection in AJCC Stage III (TxN1-2MO) Melanoma Patients: a Randomized Phase III Trial
Study Start Date : June 2000
Actual Primary Completion Date : August 2003

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma
Drug Information available for: Interferon

Arm Intervention/treatment
No Intervention: observation
5 years observation + 5 years follow up
Experimental: pegylated interferon alfa
5 years pegylated interferon alfa + 5 years follow up
Biological: pegylated interferon alfa
Procedure: adjuvant therapy

Primary Outcome Measures :
  1. distant-metastasis free-survival (DMFS) [ Time Frame: from randomization ]
    distant-metastasis free-survival (DMFS) after randomization

Secondary Outcome Measures :
  1. survival [ Time Frame: from randomization till death ]
    duration of survival: time from randomization until death, whatever the cause

  2. toxicity [ Time Frame: from randomization ]

Other Outcome Measures:
  1. quality of life [ Time Frame: from randomization ]
    Quality of life evaluation

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed previously resected stage III primary cutaneous melanoma or unknown primary with regional lymph node involvement

    • N1 disease

      • Microscopic, nonpalpable nodal involvement
      • Primary melanoma of any stage with clinically inapparent N1 regional lymph node metastases (T1-4, N1, M0) detected by elective lymph node dissection or sentinel node biopsy
    • N2 disease

      • Palpable nodal involvement with synchronous primary melanoma or apparent nodal disease after prior excision (any pT, N2, M0)
    • Regional lymph node recurrence at any interval after surgery for primary melanoma of any depth (T1-4, rN2, M0)
  • Complete resection of primary melanoma with adequate surgical margins
  • Full lymphadenectomy must be performed within 70 days of study
  • No mucous membrane melanoma or ocular melanoma
  • No evidence of distant or nonregional lymph node metastases or in transit metastases (even if previously resected)
  • No incompletely resected disease due to gross extracapsular extension



  • 18 to 70

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified


  • WBC at least 3,000/mm^3
  • Platelet count greater than 100,000/mm^3
  • Hemoglobin at least 9 g/dL


  • SGOT and SGPT less than 2 times upper limit of normal
  • No active hepatitis


  • Creatinine less than 2.0 mg/dL


  • No severe cardiovascular disease including the following:

    • Arrhythmias requiring chronic treatment
    • Congestive heart failure (New York Heart Association class III or IV)
    • Symptomatic ischemic heart disease


  • No other prior malignancy within the past 5 years except surgically cured nonmelanomatous skin cancer or carcinoma in situ of the cervix
  • No thyroid dysfunction unresponsive to therapy
  • No uncontrolled diabetes mellitus
  • No active autoimmune disease
  • No active and/or uncontrolled infection
  • No history of neuropsychiatric disorder requiring hospitalization
  • No known active alcohol or drug abuse
  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • No prior interferon alfa
  • No prior immunotherapy for melanoma
  • No other concurrent immunologic or biologic therapy
  • No concurrent colony stimulating factors including epoetin alfa and filgrastim (G-CSF)


  • No prior chemotherapy for melanoma
  • No concurrent chemotherapy

Endocrine therapy:

  • No prior hormonal therapy for melanoma
  • No concurrent hormonal therapy
  • No concurrent chronic systemic corticosteroid therapy


  • No prior radiotherapy for melanoma
  • No concurrent radiotherapy


  • See Disease Characteristics
  • Recovered from any prior recent surgery


  • At least 30 days since other prior experimental therapy
  • No other concurrent investigational drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006249

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Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
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Study Chair: Alexander M. M. Eggermont, MD, PhD Daniel Den Hoed Cancer Center at Erasmus Medical Center
Publications of Results:
Eggermont AM, Suciu S, Santinami M, et al.: EORTC 18991 phase III trial: Long-term adjuvant pegylated interferon-α2b (PEG-IFN) versus observation in resected stage III melanoma: long-term results at 7.6-years follow-up. [Abstract] J Clin Oncol 29 (Suppl 15): A-8506b, 2011.
Eggermont AM, Suciu S, Santinami M, et al.: EORTC 18991: long-term adjuvant pegylated interferon-alpha2b (PEG-IFN) compared to observation in resected stage III melanoma, final results of a randomized phase III trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-8504, 473s, 2007.

Other Publications:
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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00006249    
Other Study ID Numbers: EORTC-18991
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: February 10, 2015
Last Verified: February 2015
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
stage III melanoma
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs