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
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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 |
OBJECTIVES:
- 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.
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 |

Arm | Intervention/treatment |
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No Intervention: observation
5 years observation + 5 years follow up
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Experimental: pegylated interferon alfa
5 years pegylated interferon alfa + 5 years follow up
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Biological: pegylated interferon alfa Procedure: adjuvant therapy |
- distant-metastasis free-survival (DMFS) [ Time Frame: from randomization ]distant-metastasis free-survival (DMFS) after randomization
- survival [ Time Frame: from randomization till death ]duration of survival: time from randomization until death, whatever the cause
- toxicity [ Time Frame: from randomization ]toxicity
- quality of life [ Time Frame: from randomization ]Quality of life evaluation

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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 |
DISEASE CHARACTERISTICS:
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Histologically confirmed previously resected stage III primary cutaneous melanoma or unknown primary with regional lymph node involvement
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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
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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)
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- 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
PATIENT CHARACTERISTICS:
Age:
- 18 to 70
Performance status:
- ECOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,000/mm^3
- Platelet count greater than 100,000/mm^3
- Hemoglobin at least 9 g/dL
Hepatic:
- SGOT and SGPT less than 2 times upper limit of normal
- No active hepatitis
Renal:
- Creatinine less than 2.0 mg/dL
Cardiovascular:
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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
Other:
- 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
PRIOR CONCURRENT THERAPY:
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)
Chemotherapy:
- 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
Radiotherapy:
- No prior radiotherapy for melanoma
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
- Recovered from any prior recent surgery
Other:
- At least 30 days since other prior experimental therapy
- No other concurrent investigational drugs

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

Study Chair: | Alexander M. M. Eggermont, MD, PhD | Daniel Den Hoed Cancer Center at Erasmus Medical Center |
Other Publications:
Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
ClinicalTrials.gov Identifier: | NCT00006249 |
Other Study ID Numbers: |
EORTC-18991 EORTC-18991 |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | February 10, 2015 |
Last Verified: | February 2015 |
stage III melanoma |
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |
Interferons Interferon-alpha Antineoplastic Agents Antiviral Agents Anti-Infective Agents Immunologic Factors Physiological Effects of Drugs |