Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00086866
Status:
UNKNOWN
Last Update Posted:
2015-02-10
First Post:
2004-07-08
Brief Title:
Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed With Surgery
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2015-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
OBJECTIVES
Primary
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 D13-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 34 vaccine-related toxicity in patients treated with these regimens
Secondary
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
Induction therapy
Arm I Patients receive immunization comprising D13-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 D13-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
Primary
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 D13-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 34 vaccine-related toxicity in patients treated with these regimens
Secondary
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
Induction therapy
Arm I Patients receive immunization comprising D13-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 D13-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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2004-001937-40 | EUDRACT_NUMBER | None | None |
| EORTC-18031 | None | None | None |
| EORTC-16032 | None | None | None |
| GSK-249553008 | None | None | None |