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Sponsored by: |
European Organization for Research and Treatment of Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00006249 |
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 | Intervention | Phase |
---|---|---|
Melanoma (Skin) |
Drug: pegylated interferon alfa Procedure: adjuvant therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
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 |
OBJECTIVES:
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.
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.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed previously resected stage III primary cutaneous melanoma or unknown primary with regional lymph node involvement
N1 disease
N2 disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
No severe cardiovascular disease including the following:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Investigator: | Alexander M. M. Eggermont, MD, PhD | Daniel Den Hoed Cancer Center at Erasmus Medical Center |
Study ID Numbers: | CDR0000068181, EORTC-18991 |
Study First Received: | September 11, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00006249 |
Health Authority: | United States: Federal Government |
stage III melanoma |
Interferon-alpha Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Interferons Peginterferon alfa-2b |
Neuroepithelioma Nevus Interferon Alfa-2a Interferon Alfa-2b Neuroendocrine Tumors Melanoma |
Anti-Infective Agents Neoplasms by Histologic Type Immunologic Factors Antineoplastic Agents Growth Substances Neoplasms, Nerve Tissue Physiological Effects of Drugs Antiviral Agents |
Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Therapeutic Uses Nevi and Melanomas Growth Inhibitors Angiogenesis Modulating Agents |