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Interferon alfa Following Surgery in Treating Patients With Stage III Melanoma Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Interferon alfa Following Surgery in Treating Patients With Stage III Melanoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Interferon alfa Following Surgery in Treating Patients With Stage III Melanoma Clinical research trials and Interferon alfa Following Surgery in Treating Patients With Stage III Melanoma healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Interferon alfa Following Surgery in Treating Patients With Stage III Melanoma. Interferon alfa Following Surgery in Treating Patients With Stage III Melanoma Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Interferon alfa Following Surgery in Treating Patients With Stage III Melanoma clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Interferon alfa Following Surgery in Treating Patients With Stage III Melanoma condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Interferon alfa Following Surgery in Treating Patients With Stage III Melanoma  Interferon alfa Following Surgery in Treating Patients With Stage III Melanoma
Interferon alfa Following Surgery in Treating Patients With Stage III Melanoma
For Condition: stage 3 melanoma
Status: No longer recruiting
Sponsor(s): EORTC Melanoma Cooperative Group ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/70 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - 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 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: - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AlexanderEggermont, , Erasmus University Medical Center
Centre Hospitalier Regional Metz Thionville
Thionville, , 57126
France
Universitaet Wuerzburg/Hautkrankheiten
Wuerzburg, , D-97080
Germany
Instituto Portugues de Oncologia Centro do Porto, SA
Porto, , 4200
Portugal
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Warsaw, , 02-781
Poland
Hopital L'Archet - 2
Nice, , F-06202
France
Istituto Regina Elena
Rome, , 00161
Italy
Great Poland Cancer Center
Poznan, , 61 866
Poland
Stadt. Kliniken
Dortmund, , 44123
Germany
Centre Leon Berard
Lyon, , 69373
France
Erasmus University Medical Center
Rotterdam, , 3075 EA
Netherlands
European Institute of Oncology - Chemo Prevention
Milano, , 20141
Italy
Hopital St. Eloi
Montpellier, , 34295
France
University Hospital Sestre Milosrdnice
Zagreb, , 10000
Croatia
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, , 34298
France
Universitaets-Hautklinik Heidelberg
Heidelberg, , D-69115
Germany
Universitaet Leipzig - Chirurgische Klinik und Poliklinik I
Leipzig, , D-04103
Germany
Wolfson Medical Center
Holon, , 58100
Israel
Universitaet Erlangen
Erlangen, , D-91054
Germany
Centre Alexis Vautrin
Vandoeuvre-les-Nancy, , 54511
France
Otto - Von - Guericke - Universitaet Magdeburg
Magdeburg, , D-39120
Germany
Centro di Riferimento Oncologico - Aviano
Aviano, , 33081
Italy
Newcastle General Hospital
Newcastle upon Tyne, England, NE4 6BE
United Kingdom
Universitair Ziekenhuis Antwerpen
Edegem, , B-2650
Belgium
Instituto Portugues de Oncologia de Francisco Gentil - Centro de Lisboa
Lisbon, , 1099-023 Codex
Portugal
Clatterbridge Centre for Oncology NHS Trust
Merseyside, England, CH63 4JY
United Kingdom
Royal Perth Hospital
Perth, Western Australia, 6000
Australia
Robert Roessle Klinik
Berlin, , D-13122
Germany
Churchill Hospital
Oxford, , OX3 7LJ
United Kingdom
Centre Hospitalier Regional et Universitaire de Saint-Etienne
Saint-Priest-en-Jarez, , 42277
France
Istituto Nazionale per la Ricerca sul Cancro
Genoa (Genova), , 16132
Italy
Selly Oak Hospital at University Hospital NHS Trust
Birmingham, , B29 6JD
United Kingdom
Royal Free Hospital
London, England, NW3 2QG
United Kingdom
Southampton General Hospital
Southampton, England, SO16 6YD
United Kingdom
Hopital Saint Andre
Bordeaux, , 33075
France
St. George's Hospital
London, England, SW17 0QT
United Kingdom
Hopital Haut Leveque
Pessac, , 33604
France
Kantonspital Aarau
AARAU, , 5001
Switzerland
Royal Devon and Exeter Hospital
Exeter, England, EX2 5DW
United Kingdom
Velindre Cancer Center at Velinde Hospital
Cardiff, Wales, CF4 7XL
United Kingdom
Ospendale S.M. Annunziata-A.S.DI Firenze
Firenze, , I-50011
Italy
U.Z. Gasthuisberg
Leuven, , B-3000
Belgium
Centre Rene Huguenin
Saint Cloud, , 92211
France
Guy's and St. Thomas' Hospitals NHS Trust
London, England, SE1 9RT
United Kingdom
Vakif Gureba Training Hospital
Istanbul, , 34296
Turkey
Tel-Aviv Sourasky Medical Center
Tel Aviv, , 64239
Israel
UniversitaetsSpital
Zurich, , CH-8091
Switzerland
David Maddison Clincial Sciences
Newcastle, , NSW 2300
Australia
Addenbrooke's NHS Trust
Cambridge, England, CB2 2QQ
United Kingdom
Saint Josef Hospital
Bochum 1, , D-44791
Germany
Hopitaux Universitaire de Strasbourg
Strasbourg, , 67091
France
Salisbury District Hospital
Salisbury, England, SP2 8BJ
United Kingdom
Royal Surrey County Hospital
Guildford, England, GU2 5XX
United Kingdom
Istituto Nazionale per lo Studio e la Cura dei Tumori
Milano (Milan), , 20133
Italy
CHR de Grenoble - La Tronche
Grenoble, , 38043
France
Centre Hospitalier Universitaire Bretonneau de Tours
Tours, , 37044
France
Southend NHS Trust Hospital
Westcliff-On-Sea, England, SS0 0RY
United Kingdom
Institut Jules Bordet
Brussels, , 1000
Belgium
Western Infirmary
Glasgow, Scotland, G11 6NT
United Kingdom
Hopital Universitaire Erasme
Brussels, , 1070
Belgium
Leicester Royal Infirmary
Leicester, England, LE1 5WW
United Kingdom
Centre Hospital Regional Universitaire de Limoges
Limoges, , 87042
France
Rambam Medical Center
Haifa, , 31096
Israel
Peter MacCallum Cancer Institute
East Melbourne, Victoria, 8006
Australia
CHU Ambroise Pare
Boulogne-Billancourt, , F-92104
France
Ratisches Kantons und Regionalspital
Chur, , CH-7000
Switzerland
Ninewells Hospital and Medical School
Dundee, Scotland, DD1 9SY
United Kingdom
Centre Eugene Marquis
Rennes, , 35042
France
Charles University Hospital
Prague (Praha), , 128 08
Czech Republic
Institute of Oncology, Ljubljana
LJUBLJANA, , Sl-1000
Slovenia
Centre Hospitalier Universitare d'Amens
Amiens, , 80054
France
Academisch Ziekenhuis Utrecht
Utrecht, , 3584 CX
Netherlands
Cliniques Universitaires Saint-Luc
Brussels, , 1200
Belgium
Centre Hospitalier Universitaire
Reims, , 51092
France
Sir Charles Gairdner Hospital, Perth
Perth, Western Australia, 6009
Australia
Institut Gustave Roussy
Villejuif, , F-94805
France
St. James's Hospital
Leeds, England, LS9 7TF
United Kingdom
Universita Degli Studi di Torino
Torino, , 10126
Italy
Hopital Bichat - Claude Bernard
Paris, , 75018
France
University Medical Center Nijmegen
Nijmegen, , NL-6500 HB
Netherlands
Clinique Notre Dame de Grace
Gosselies, , 6041
Belgium
CHR de Besancon - Hopital Saint-Jacques
Besancon, , 25030
France
Haematologisch-Onkologische Praxis Altona
Hamburg, , D-22765
Germany
Bristol Haematology and Oncology Centre
Bristol, England, BS2 8ED
United Kingdom
Hospital Clinico Universitario
Zaragoza, , 50009
Spain
Vrije Universiteit Medisch Centrum
Amsterdam, , 1007 MB
Netherlands
Austin and Repatriation Medical Centre
Heidelberg West, Victoria, 3081
Australia
Leiden University Medical Center
Leiden, , 2300 CA
Netherlands
Hospital Universitario 12 de Octubre
Madrid, , 28041
Spain
National Centre of Oncology
Sofia, , 1756
Bulgaria
North-Estonian Regional Hospital Cancer Centre
Tallinn, , 11619
Estonia
Centre Hospitalier Regional et Universitaire de Lille
Lille, , 59037
France
Ege University Medical School
Izmir, , 35220
Turkey
Georg August Universitaet
Goettingen, , D-37075
Germany
Istituto Nazionale per lo Studio e la Cura dei Tumori
Naples, , 80131
Italy
Weston Park Hospital
Sheffield, England, S1O 2SJ
United Kingdom
Inselspital, Bern
BERN, , CH-3010
Switzerland
Klinikum der Stadt Mannheim
Mannheim, , D-68135
Germany
Princess Royal Hospital
Hull, England, HU8 9HE
United Kingdom
Royal Marsden NHS Trust
London, England, SW3 6JJ
United Kingdom
Cheltenham General Hospital
Cheltenham, England, GL53 7AN
United Kingdom
Saint Bartholomew's Hospital
London, England, EC1A 7BE
United Kingdom
Hopital Saint-Louis
Paris, , 75475
France
Royal Marsden Hospital
Sutton, England, SM2 5PT
United Kingdom
Belfast City Hospital Trust
Belfast, Northern Ireland, BT9 7AB
United Kingdom
Additional Information:
Study ID Numbers: CDR0000068181; EORTC-18991
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006249
Other Stage 3 Melanoma Studies:
1. Interleukin-2 Plus Bryostatin 1 in Treating Patients With Melanoma or Kidney Cancer
2. Detection of Melanoma Markers in Lymph Nodes or Peripheral Blood of Patients With Melanoma
3. High-Dose Interferon alfa in Treating Patients With Stage II or Stage III Melanoma
4. Interferon alfa or No Further Therapy Following Surgery in Treating Patients With Stage II, Stage III, or Recurrent Melanoma
5. Vaccine Therapy in Treating Patients With Unresectable Metastatic Melanoma
Related Studies:
Other stage 3 melanoma Clinical Trials
Other Clinical Trials
Other Leiden Clinical Trials
Interferon alfa Following Surgery in Treating Patients With Stage III Melanoma
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