|
Vaccine Therapy in Treating Patients With Primary Stage II Melanoma Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Vaccine Therapy in Treating Patients With Primary Stage II Melanoma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Vaccine Therapy in Treating Patients With Primary Stage II Melanoma Clinical research trials and Vaccine Therapy in Treating Patients With Primary Stage II Melanoma health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Vaccine Therapy in Treating Patients With Primary Stage II Melanoma. Vaccine Therapy in Treating Patients With Primary Stage II Melanoma Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Vaccine Therapy in Treating Patients With Primary Stage II Melanoma clinical trial. Subjects frequently get the best healthcare possible for their Vaccine Therapy in Treating Patients With Primary Stage II Melanoma condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "V" Clinical Trials Conditions > Vaccine Therapy in Treating Patients With Primary Stage II Melanoma  Vaccine Therapy in Treating Patients With Primary Stage II Melanoma
Vaccine Therapy in Treating Patients With Primary Stage II Melanoma
For Condition: stage 2 melanoma
Status: Recruiting
Sponsor(s): EORTC Melanoma Cooperative Group ,
Synopsis: RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. It is not yet known whether vaccine therapy is more effective than observation alone for melanoma. PURPOSE: Randomizedphase III trial to determine the effectiveness of vaccine therapy in treating patients who have primarystage II melanoma.
Details: OBJECTIVES: - Compare the effect of immunization with GM2-KLH and QS21 to observation on the disease-free survival of patients with primary cutaneous stage II melanoma after adequate surgery. - Determine overall survival and toxicity in the two treatment arms. OUTLINE: This is a randomized, open-label, parallel, multicenter study. Patients are stratified according to participating center, tumor thickness (greater than 1.5 to 3.0 mm vs greater than 3.0 to 4.0 mm vs greater than 4.0 mm), gender, ulceration (yes vs no), and presence of additional staging procedures of regional lymph nodes (yes vs no). Patients are randomized to one of two arms. - Arm I: Patients are vaccinated with GM2-KLH and QS21 subcutaneously on day 1 of weeks 1-4, 12, 24, 36, 48, 60, 72, 84, 96, 120, and 144 for a total of 14 vaccinations. - Arm II: Patients undergo observation. Patients are followed every 6 months for 7 years. PROJECTED ACCRUAL: A total of 1300 patients (650 per arm) will be accrued for this study within 36 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/80 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed primary stage II melanoma greater than 1.5 mm without evidence of lymph node metastases - T3 or T4, N0, M0 - Must originate in the skin - Wide excision with a minimum of 1-2 cm margin surrounding primary lesion or biopsy scar - No more than 56 days since definitive surgical treatment (wide excision) - No more than 12 weeks since primary surgery - No clinical, radiological, or pathological evidence of incompletely resected disease, lymph node metastases, in-transit metastasis, or any distant metastatic disease PATIENT CHARACTERISTICS: Age: - 18 to 80 Performance status: - ECOG 0-1 Life expectancy: - Not specified Hematopoietic: - WBC at least 3,000/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 9.8 g/dL Hepatic: - SGOT/SGPT no greater than 2 times upper limit of normal (ULN) - Alkaline phosphatase no greater than 2 times ULN - LDH no greater than 2 times ULN - Bilirubin no greater than 2 times ULN - Hepatitis B and C negative Renal: - Creatinine normal Other: - Not pregnant or nursing - Negative pregnancy test - No prior or other concurrent cancer except carcinoma in situ of the cervix or basal or squamous cell skin cancer - No autoimmune disorders - No conditions requiring systemic treatment with immunosuppressive drugs including treatment with systemic corticosteroids - No history of CNS demyelinating or inflammatory disease - No hereditary or acquired peripheral neuropathy - No other significant medical or surgical condition or psychiatric disorders requiring medication that would preclude study - No history of severe allergic reaction to shellfish - HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior immunotherapy - No other concurrent biologic therapy Chemotherapy: - No prior systemic chemotherapy - No concurrent cytotoxic chemotherapy Endocrine therapy: - No concurrent hormonal therapy except replacement therapy - No concurrent corticosteroids - No concurrent chronic systemic steroids Radiotherapy: - No prior adjuvant radiotherapy - No concurrent radiotherapy Surgery: - See Disease Characteristics Other: - No prior preoperative infusion or perfusion therapy - No concurrent immunosuppressive medications - No other concurrent anticancer therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AlexanderEggermont, , Daniel Den Hoed Cancer Center at Erasmus Medical Center
Hospital Distrital De Santarem *Recruiting*
Santarem, , 2000
Portugal
Recruiting Contact Person 351-243-300-200
Universitaet Leipzig - Chirurgische Klinik und Poliklinik I *Recruiting*
Leipzig, , D-04103
Germany
Recruiting Contact Person 49-341-9717-000
Cheltenham General Hospital *Recruiting*
Cheltenham, England, GL53 7AN
United Kingdom
Recruiting Contact Person 44-1242-222-222
Royal Surrey County Hospital *Recruiting*
Guildford, England, GU2 5XX
United Kingdom
Recruiting Contact Person 44-1483-406-767
Herlev Hospital - University Hospital of Copenhagen *Recruiting*
Copenhagen, , DK-2730
Denmark
Recruiting Contact Person 45-3-4453-5300
CHU Ambroise Pare *Recruiting*
Boulogne-Billancourt, , F-92104
France
Recruiting Contact Person 33-149-095-000
Centre Hospitalier Universitaire Vaudois *Recruiting*
Lausanne, , CH-1011
Switzerland
Recruiting Contact Person 41-21-314-1111
Hopital St. Eloi *Recruiting*
Montpellier, , 34295
France
Recruiting Contact Person 33-4-6733-6733
Royal Free Hospital *Recruiting*
London, England, NW3 2QG
United Kingdom
Recruiting Contact Person 44-20-7794-0500
Weston Park Hospital *Recruiting*
Sheffield, England, S1O 2SJ
United Kingdom
Recruiting Contact Person 44-114-226-5000
Hospital Clinico Universitario *Recruiting*
Zaragoza, , 50009
Spain
Recruiting Contact Person 34-976-350-418
Selly Oak Hospital at University Hospital NHS Trust *Recruiting*
Birmingham, , B29 6JD
United Kingdom
Recruiting Contact Person 44-21-627-1627
Centre Antoine Lacassagne *Recruiting*
Nice, , 06189
France
Recruiting Contact Person 33-4-9203-1000
Hopital L'Archet - 2 *Recruiting*
Nice, , F-06202
France
Recruiting Contact Person 33-492-036-489
Broomfield Hospital *Recruiting*
Chelmsford, Essex, England, CM1 5ET
United Kingdom
Recruiting Contact Person 44-245-440-761
Addenbrooke's NHS Trust *Recruiting*
Cambridge, England, CB2 2QQ
United Kingdom
Recruiting Contact Person 44-1223-245-151
Cliniques Universitaires Saint-Luc *Recruiting*
Brussels, , 1200
Belgium
Recruiting Contact Person 32-2-764-1111
Haematologisch-Onkologische Praxis Altona *Recruiting*
Hamburg, , D-22765
Germany
Recruiting Contact Person 49-40-380-2120
U.Z. Gasthuisberg *Recruiting*
Leuven, , B-3000
Belgium
Recruiting Contact Person 32-16-33-2211
Rigshospitalet *Recruiting*
Copenhagen, , 2100
Denmark
Recruiting Contact Person 45-3-454-4286
Hospital Universitario 12 de Octubre *Recruiting*
Madrid, , 28041
Spain
Recruiting Contact Person 34-913-390-8003
St. George's Hospital *Recruiting*
London, England, SW17 0QT
United Kingdom
Recruiting Contact Person 44-20-8672-1255
Centre Hospitalier Universitaire Bretonneau de Tours *Recruiting*
Tours, , 37044
France
Recruiting Contact Person 33-2-4747-4776
Hopital Universitaire Erasme *Recruiting*
Brussels, , 1070
Belgium
Recruiting Contact Person 32-2-555-3111
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology *Recruiting*
Warsaw, , 02-781
Poland
Recruiting Contact Person 48-22-546-2169
Hopital Bichat - Claude Bernard *Recruiting*
Paris, , 75018
France
Recruiting Contact Person 33-1-4025-7000
Royal Perth Hospital *Recruiting*
Perth, Western Australia, 6000
Australia
Recruiting Contact Person 61-9-224-2244
Instituto Portugues de Oncologia Centro do Porto, SA *Recruiting*
Porto, , 4200
Portugal
Recruiting Contact Person 351-22-550-2011
Universita Degli Studi di Torino *Recruiting*
Torino, , 10126
Italy
Recruiting Contact Person 39-11-696-7472
Ninewells Hospital and Medical School *Recruiting*
Dundee, Scotland, DD1 9SY
United Kingdom
Recruiting Contact Person 44-1382-660-111
Western General Hospital *Recruiting*
Edinburgh, Scotland, EH4 2XU
United Kingdom
Recruiting Contact Person 44-131-777-3500
Clatterbridge Centre for Oncology NHS Trust *Recruiting*
Merseyside, England, CH63 4JY
United Kingdom
Recruiting Contact Person 44-151-334-1155
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle *Recruiting*
Montpellier, , 34298
France
Recruiting Contact Person 33-4-6761-3100
Southampton General Hospital *Recruiting*
Southampton, England, SO16 6YD
United Kingdom
Recruiting Contact Person 44-1703-8079-6185
Daniel Den Hoed Cancer Center at Erasmus Medical Center *Recruiting*
Rotterdam, , 3008 AE
Netherlands
Recruiting Contact Person 31-10-439-1911
Aarhus Kommunehospital *Recruiting*
Aarhus, , DK-8000
Denmark
Recruiting Contact Person 45-8-612-5555
Istituto Nazionale per la Ricerca sul Cancro *Recruiting*
Genoa (Genova), , 16132
Italy
Recruiting Contact Person 39-010-560-0848
Hopital Saint-Louis *Recruiting*
Paris, , 75475
France
Recruiting Contact Person 33-1-4249-4949
Istituto Nazionale per lo Studio e la Cura dei Tumori *Recruiting*
Milano (Milan), , 20133
Italy
Recruiting Contact Person 39-2-390-291
St. James's University Hospital *Recruiting*
Leeds, England, LS9 7TF
United Kingdom
Recruiting Contact Person 44-113-206-4904
Royal Marsden NHS Trust - London *Recruiting*
London, England, SW3 6JJ
United Kingdom
Recruiting Contact Person 44-20-7352-8171
Centre Hospitalier Regional et Universitaire de Lille *Recruiting*
Lille, , 59037
France
Recruiting Contact Person 33-3-2044-4255
Centre Jean Perrin *Recruiting*
Clermont-Ferrand, , 63011
France
Recruiting Contact Person 33-4-73-278-080
CHR de Besancon - Hopital Saint-Jacques *Recruiting*
Besancon, , 25030
France
Recruiting Contact Person 33-3-8166-8166
Great Poland Cancer Center *Recruiting*
Poznan, , 61 866
Poland
Recruiting Contact Person 48-61-8540-700
Universitair Ziekenhuis Gent *Recruiting*
Ghent, , B-9000
Belgium
Recruiting Contact Person 32-92-240-2011
Universitair Ziekenhuis Antwerpen *Recruiting*
Edegem, , B-2650
Belgium
Recruiting Contact Person 32-3-821-3000
Centre Eugene Marquis *Recruiting*
Rennes, , 35042
France
Recruiting Contact Person 32-2-9925-3178
CHU de Caen *Recruiting*
Caen, , 14033
France
Recruiting Contact Person 33-2-3127-2508
Southend NHS Trust Hospital *Recruiting*
Westcliff-On-Sea, England, SS0 0RY
United Kingdom
Recruiting Contact Person 44-1702-435-555
Centre Alexis Vautrin *Recruiting*
Vandoeuvre-les-Nancy, , 54511
France
Recruiting Contact Person 33-3-8359-8400
Velindre Cancer Center at Velinde Hospital *Recruiting*
Cardiff, Wales, CF4 7XL
United Kingdom
Recruiting Contact Person 44-29-2061-5888
Royal Marsden Hospital - Sutton *Recruiting*
Sutton, England, SM2 5PT
United Kingdom
Recruiting Contact Person 44-20-8642-6011
Universitaets-Hautklinik Wuerzburg *Recruiting*
Wuerzburg, , D-97080
Germany
Recruiting Contact Person 49-931-201-2728
Centre Rene Huguenin *Recruiting*
Saint Cloud, , 92211
France
Recruiting Contact Person 33-147-441-501
University Medical Center Nijmegen *Recruiting*
Nijmegen, , NL-6500 HB
Netherlands
Recruiting Contact Person 31-24-361-1111
Istituto Nazionale per lo Studio e la Cura dei Tumori *Recruiting*
Naples, , 80131
Italy
Recruiting Contact Person 39-81-590-3269
Clinique Notre Dame de Grace *Recruiting*
Gosselies, , 6041
Belgium
Recruiting Contact Person 32--71-379-000
Salisbury District Hospital *Recruiting*
Salisbury, England, SP2 8BJ
United Kingdom
Recruiting Contact Person 44-1722-336-262
Norwegian Radium Hospital *Recruiting*
Oslo, , N-0310
Norway
Recruiting Contact Person 47-22-934-000
Istituto Regina Elena *Recruiting*
Rome, , 00161
Italy
Recruiting Contact Person 39-06-52-661
Tampere University Hospital *Recruiting*
Tampere, , 33521
Finland
Recruiting Contact Person 358-3-247-3239
Odense University Hospital *Recruiting*
Odense, , DK-5000
Denmark
Recruiting Contact Person 45-66-113-333
Centre Hospitalier Regional Metz Thionville *Recruiting*
Thionville, , 57126
France
Recruiting Contact Person 33-3-8255-8899
Center for Tumor Detection and Prevention *Recruiting*
St. Gallen, , CH-9006
Switzerland
Recruiting Contact Person 41-71-243-0043
Hopital de Jolimont *Recruiting*
Haine-Saint-Paul, , 7100
Belgium
Recruiting Contact Person 32-64-233-011
Institut Gustave Roussy *Recruiting*
Villejuif, , F-94805
France
Recruiting Contact Person 33-142-114-211
Ospendale S.M. Annunziata-A.S.DI Firenze *Recruiting*
Firenze, , I-50011
Italy
Recruiting Contact Person 39-55-249-6439
Universita di Padova *Recruiting*
Padova, , 35128
Italy
Recruiting Contact Person 39-30-821-2055
Centro di Riferimento Oncologico - Aviano *Recruiting*
Aviano, , 33081
Italy
Recruiting Contact Person 39-0434-6591
Ratisches Kantons und Regionalspital *Recruiting*
Chur, , CH-7000
Switzerland
Recruiting Contact Person 41-81-221-447
Additional Information:
Study ID Numbers: CDR0000067645; EORTC-18961,BMS-CA152-003
Study Start Date:
Record last reviewed: July 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005052
Other Stage 2 Melanoma Studies:
1. Vaccine Therapy in Treating Patients With Primary Stage II Melanoma
2. Interferon alfa-2b in Treating Patients With Melanoma and Early Lymph Node Metastasis
3. Boron Neutron Capture Therapy in Treating Patients With Melanoma
4. Diagnostic Study to Predict the Risk of Developing Metastatic Cancer in Patients With Stage I or Stage II Melanoma
5. High-Dose Interferon alfa in Treating Patients With Stage II or Stage III Melanoma
Related Studies:
Other stage 2 melanoma Clinical Trials
Other Clinical Trials
Other Hamburg Clinical Trials
Vaccine Therapy in Treating Patients With Primary Stage II Melanoma
|
|
|
|
|
|
|
|
