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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: | NCT00086866 |
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: This randomized phase II trial is studying two different regimens of vaccine therapy and comparing them to see how well they work in treating patients with stage III or stage IV melanoma that cannot be removed with surgery.
Condition | Intervention | Phase |
---|---|---|
Melanoma (Skin) |
Drug: D1/3-MAGE-3-His fusion protein Drug: SB-AS02B adjuvant Drug: SB-AS15 adjuvant |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
Official Title: | Randomized, Open Phase II Study of Immunization With the Recombinant MAGE-3 Protein Combined With Adjuvant AS02B or AS15 in Patients With Unresectable and Progressive Metastatic Cutaneous Melanoma |
Estimated Enrollment: | 68 |
Study Start Date: | May 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, open label, parallell-group, multicenter study. Patients are stratified according to disease stage (III in transit vs other stage III vs IV), presence of lesion ≥ 20 mm (yes vs no), and participating center. Patients are randomized to 1 of 2 treatment arms.
Induction therapy
Patients achieving a clinical complete response (CR), partial response (PR), stable disease (SD), or slow progressive disease (SPD) proceed to maintenance therapy.
Patients maintaining a CR, PR, or SD proceed to long-term treatment.
Treatment continues in both arms in the absence of disease progression that does not correspond to SPD status, unacceptable toxicity, or the diagnosis of an autoimmune disease.
Patients are followed every 12 weeks.
PROJECTED ACCRUAL: A total of 68 patients (34 patients per treatment arm) will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed cutaneous melanoma
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
No concurrent corticosteroids
Radiotherapy
No concurrent radiotherapy to > 20% of all existing lesions (i.e., target lesions, non-target lesions, and nonmeasurable lesions)
Surgery
Other
Belgium | |
Hopital Universitaire Erasme | |
Brussels, Belgium, 1070 | |
Institut Jules Bordet | |
Brussels, Belgium, 1000 | |
France | |
Centre Hospitalier Regional et Universitaire de Lille | |
Lille, France, 59037 | |
CHR Hotel Dieu | |
Nantes, France, 44093 | |
Clinique Sainte-Marguerite | |
Hyeres, France, 83400 | |
Hopital St. Eloi | |
Montpellier, France, 34295 | |
Institut Curie Hopital | |
Paris, France, 75248 | |
Institut Gustave Roussy | |
Villejuif, France, F-94805 | |
Germany | |
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin | |
Berlin, Germany, D-12200 | |
Klinikum der Stadt Mannheim | |
Mannheim, Germany, D-68135 | |
Universitaets - Kinderklinik Wuerzburg | |
Wuerzburg, Germany, D-97080 | |
Italy | |
Azienda Ospedaliera di Padova | |
Padova, Italy, 35128 | |
Centro di Riferimento Oncologico - Aviano | |
Aviano, Italy, 33081 | |
Istituto Nazionale per lo Studio e la Cura dei Tumori | |
Naples, Italy, 80131 | |
Universita di Siena | |
Siena, Italy, 53100 | |
Netherlands | |
Daniel Den Hoed Cancer Center at Erasmus Medical Center | |
Rotterdam, Netherlands, 3008 AE | |
Leiden University Medical Center | |
Leiden, Netherlands, 2300 RC | |
Spain | |
Hospital Clinic de Barcelona | |
Barcelona, Spain, 08036 | |
Hospital Universitario 12 de Octubre | |
Madrid, Spain, 28041 | |
United Kingdom, England | |
Christie Hospital NHS Trust | |
Manchester, England, United Kingdom, M20 4BX | |
Saint Bartholomew's Hospital | |
London, England, United Kingdom, EC1A 7BE |
Investigator: | Willem H. J. Kruit, MD, PhD | Daniel Den Hoed Cancer Center at Erasmus Medical Center |
Investigator: | Cornelis J. A. Punt, MD, PhD | Universitair Medisch Centrum St. Radboud - Nijmegen |
Study ID Numbers: | CDR0000371707, EORTC-18031, EORTC-16032, GSK-249553/008, EUDRACT-2004-001937-40 |
Study First Received: | July 8, 2004 |
Last Updated: | August 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00086866 |
Health Authority: | United States: Federal Government |
stage III melanoma stage IV melanoma recurrent melanoma |
Neuroectodermal Tumors Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Melanoma, familial Neuroepithelioma |
Nevus Recurrence Neuroendocrine Tumors Melanoma |
Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas |