High-Dose or Low-Dose Interferon Alfa Compared With No Further Therapy Following Surgery in Treating Patients With Stage III Melanoma
Melanoma (Skin)
About this trial
This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage III melanoma, recurrent melanoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Cutaneous melanoma in one of the following categories: T4, N0, M0 Deep primary tumor with Breslow depth greater than 4.0 cm Tx, N1, M0 Primary tumor with regional lymph node metastases found at lymphadenectomy but clinically undetectable Tx, N2, M0 Clinically apparent regional lymph node metastases (synchronous or metachronous) confirmed by lymphadenectomy Definitive surgical resection and lymphadenectomy with pathologically confirmed adequate surgical margins required Minimum 2 cm margin for primary lesions with Breslow depth greater than 2 mm Distal interphalangeal amputation required for subungual melanomas No primary melanoma originating apart from the skin No multiple in transit metastases in an extremity No lymph node involvement outside the operative area resected by radical neck, axillary lymph node, or ilioinguinal dissection PATIENT CHARACTERISTICS: Age: 16 to 75 Performance status: ECOG 0 or 1 Hematopoietic: WBC at least 4,000 Platelets at least 125,000 Hemoglobin at least 9.8 g/dL (6.1 mmol/L) Hepatic: Bilirubin no greater than 2 times normal AST no greater than 2 times normal Renal: Creatinine no greater than 1.6 mg/dL (140 micromoles/L) Cardiovascular: No ventricular or supraventricular arrhythmia requiring treatment No congestive heart failure (NYHA class 3/4 status) Other: No uncontrolled infection No requirement for ongoing steroids, NSAIDs, or other immunomodulators No organic brain syndrome or significant impairment of basal cognitive function No psychiatric disorder that would preclude study participation or would be exacerbated by study therapy (e.g., depression) No second malignancy except: In situ cervical cancer Nonmelanomatous skin cancer No pregnant or nursing women PRIOR CONCURRENT THERAPY: No prior treatment on this protocol for patients with recurrent melanoma at regional lymph nodes No preoperative infusion or perfusion therapy Biologic therapy: No prior adjuvant immunotherapy Chemotherapy: No prior adjuvant systemic chemotherapy No prior anthracyclines Endocrine therapy: Not specified Radiotherapy: No prior adjuvant radiotherapy Surgery: See Disease Characteristics
Sites / Locations
- Krankenhaus der Elisabethinen
- Landeskrankenanstalten - Salzburg
- Institut Jules Bordet
- Cliniques Universitaires Saint-Luc
- Hopital Universitaire Erasme
- Centre Hospitalier Notre Dame - Reine Fabiola
- Universitair Ziekenhuis Antwerpen
- Universitair Ziekenhuis Gent
- U.Z. Gasthuisberg
- Alexander's University Hospital
- National Centre of Oncology
- University Hospital Sestre Milosrdnice
- Estonian Cancer Center
- Tampere University Hospital
- Turku University Central Hospital
- CHU de Bordeaux - Hopital Pellegrin
- Institut Bergonie
- CHU Ambroise Pare
- CHRU de Caen
- Centre Leon Berard
- Centre Antoine Lacassagne
- Hopital L'Archet - 2
- Hopital Bichat-Claude Bernard
- Hopital Saint-Louis
- Hopital Cochin
- Hopital Haut Leveque
- Centre Eugene Marquis
- Centre Rene Huguenin
- Centre Hospitalier Regional et Universitaire de Saint-Etienne
- Hopitaux Universitaire de Strasbourg
- Centre Hospitalier Regional Metz Thionville
- Institut Claudius Regaud
- Centre Hospitalier Universitaire Bretonneau de Tours
- Institut Gustave Roussy
- Universitaetsklinikum Benjamin Franklin
- Robert Roessle Klinik
- Universitaets-Augenklinik - Erlangen
- Georg August Universitaet
- Universitats-Krankenhaus Eppendorf
- Haematologisch-Onkologische Praxis Altona
- Department of Dematology, Hannover Medical School
- Universitaets-Hautklinik Heidelberg
- Universitatsklinik, Saarland
- III Medizinische Klinik Mannheim
- Klinikum der Universitat Regensburg
- Universitatshautklinik Eberhard - Karlsuniversitat Tubingen
- Department of Dermatology
- Universitaet Wuerzburg/Hautkrankheiten
- Wolfson Medical Center
- Tel-Aviv Medical Center-Ichilov Hospital
- Istituto Europeo Di Oncologia
- Academisch Ziekenhuis der Vrije Universiteit
- Antoni van Leeuwenhoekhuis
- Academisch Ziekenhuis Groningen
- Leiden University Medical Center
- University Medical Center Nijmegen
- Rotterdam Cancer Institute
- Academisch Ziekenhuis Utrecht
- Medical University of Gdansk
- Maria Sklodowska-Curie M.C.C.I.O. Krakow
- Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
- Instituto Portugues de Oncologia de Francisco Gentil
- Instituto Portugues de Oncologia do Porto
- Russian Academy of Medical Sciences Cancer Research Center
- Institute of Oncology and Radiology of Serbia
- National Cancer Institute - Bratislava
- Hospital Clinic y Provincial de Barcelona
- Hospital Clinico Universitario
- Huddinge Hospital
- Ospedale San Giovanni
- Inselspital, Bern
- Ratisches Kantons und Regionalspital
- Centre Hospitalier Universitaire Vaudois
- Kantonsspital - Saint Gallen
- Universitaetsspital
- Cukurova University School of Medicine
- Vakif Gureba Training Hospital
- Istanbul University-Institute of Oncology
- Cerrahpasa Medical School
- Ege University Medical School
- Bristol Oncology Centre
- Addenbrooke's NHS Trust
- St. James's Hospital
- Royal Marsden NHS Trust
- Derriford Hospital
- Beatson Oncology Centre