Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed With Surgery
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.
Biological: D1/3-MAGE-3-His fusion protein
Biological: SB-AS02B adjuvant
Biological: SB-AS15 adjuvant
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|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|
- Response rate (complete response and partial response) as assessed by RECIST criteria [ Designated as safety issue: No ]
- Vaccine-related toxicity as assessed by CTCAE v3 [ Designated as safety issue: Yes ]
- Rate of stabilization as assessed by RECIST criteria [ Designated as safety issue: No ]
- Rate of mixed response as assessed by RECIST criteria [ Designated as safety issue: No ]
- Rate of immune response [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
|Study Start Date:||May 2004|
|Primary Completion Date:||January 2007 (Final data collection date for primary outcome measure)|
- Compare the objective response rate (complete and partial response) in patients with unresectable stage III or stage IV M1a cutaneous melanoma immunized with vaccine comprising D1/3-MAGE-3-His fusion protein and SB-AS02B adjuvant vs SB-AS15 adjuvant.
- Compare the activity of SB-AS02B adjuvant vs SB-AS15 adjuvant, in terms of maximizing the antigenicity of MAGE-3, in patients treated with these regimens.
- Compare the rate of grade 3/4 vaccine-related toxicity in patients treated with these regimens.
- Compare progression-free survival in patients treated with these regimens.
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.
- Arm I: Patients receive immunization comprising D1/3-MAGE-3-His fusion protein and SB-AS02B adjuvant intramuscularly (IM) once weekly on weeks 1, 3, 5, 7, 9, and 11.
- Arm II: Patients receive immunization comprising D1/3-MAGE-3-His fusion protein SB-AS15 adjuvant IM once weekly on weeks 1, 3, 5, 7, 9, and 11.
Patients achieving a clinical complete response (CR), partial response (PR), stable disease (SD), or slow progressive disease (SPD) proceed to maintenance therapy.
- Maintenance therapy: Patients in both arms receive immunization (according to their randomized arm) once weekly on weeks 15, 18, 21, 24, 27, 30, 34, 40, 46, and 52.
Patients maintaining a CR, PR, or SD proceed to long-term treatment.
- Long-term treatment: Beginning 3 months after completion of maintenance therapy, patients in both arms receive immunization (according to their randomized arm) once every 3 months for 4 courses and then once every 6 months for 4 courses.
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.
|Hopital Universitaire Erasme|
|Brussels, Belgium, 1070|
|Institut Jules Bordet|
|Brussels, Belgium, 1000|
|Hyeres, France, 83400|
|Centre Hospitalier Regional et Universitaire de Lille|
|Lille, France, 59037|
|Hopital St. Eloi|
|Montpellier, France, 34295|
|CHR Hotel Dieu|
|Nantes, France, 44093|
|Institut Curie Hopital|
|Paris, France, 75248|
|Institut Gustave Roussy|
|Villejuif, France, F-94805|
|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|
|Centro di Riferimento Oncologico - Aviano|
|Aviano, Italy, 33081|
|Istituto Nazionale per lo Studio e la Cura dei Tumori|
|Naples, Italy, 80131|
|Azienda Ospedaliera di Padova|
|Padova, Italy, 35128|
|Universita di Siena|
|Siena, Italy, 53100|
|Leiden University Medical Center|
|Leiden, Netherlands, 2300 RC|
|Daniel Den Hoed Cancer Center at Erasmus Medical Center|
|Rotterdam, Netherlands, 3008 AE|
|Hospital Clinic de Barcelona|
|Barcelona, Spain, 08036|
|Hospital Universitario 12 de Octubre|
|Madrid, Spain, 28041|
|Saint Bartholomew's Hospital|
|London, England, United Kingdom, EC1A 7BE|
|Christie Hospital NHS Trust|
|Manchester, England, United Kingdom, M20 4BX|
|Study Chair:||Willem H. J. Kruit, MD, PhD||Daniel Den Hoed Cancer Center at Erasmus Medical Center|
|Study Chair:||Cornelis J. A. Punt, MD, PhD||Universitair Medisch Centrum St. Radboud - Nijmegen|