Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00042783
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2002-08-05
Brief Title:
Vaccine Therapy in Treating Patients With Stage IV Melanoma
Sponsor:
SWOG Cancer Research Network
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial Of A D13-MAGE3-HIS Fusion Protein NSC-719274 With Adjuvant SBAS02B NSC-719275 For Patients With Stage IV M1a or M1b Metastatic Melanoma
Status:
COMPLETED
Status Verified Date:
2004-04
Last Known Status:
None
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 Vaccine therapy may be effective in treating stage IV melanoma
PURPOSE Phase II trial to study the effectiveness of vaccine therapy in treating patients who have stage IV melanoma
PURPOSE Phase II trial to study the effectiveness of vaccine therapy in treating patients who have stage IV melanoma
Detailed Description:
OBJECTIVES
Determine the feasibility of treating patients with stage IV melanoma with D13-MAGE-3-His fusion protein with SB-AS02B adjuvant
Determine the clinically confirmed response rates partial and complete responses of patients treated with this regimen
Determine the 6-month progression-free survival rate of patients treated with this regimen
Determine the qualitative and quantitative toxic effects of this regimen in these patients
Determine immune responses in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive D13-MAGE-3-His fusion protein emulsified in SB-AS02B adjuvant intramuscularly once every 3 weeks for a total of 12 weeks 4 injections In the absence of disease progression or unacceptable toxicity patients receive a second 12-week course beginning at week 16
Patients are followed every 3 months for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 25-45 patients will be accrued for this study within 5-9 months
Determine the feasibility of treating patients with stage IV melanoma with D13-MAGE-3-His fusion protein with SB-AS02B adjuvant
Determine the clinically confirmed response rates partial and complete responses of patients treated with this regimen
Determine the 6-month progression-free survival rate of patients treated with this regimen
Determine the qualitative and quantitative toxic effects of this regimen in these patients
Determine immune responses in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive D13-MAGE-3-His fusion protein emulsified in SB-AS02B adjuvant intramuscularly once every 3 weeks for a total of 12 weeks 4 injections In the absence of disease progression or unacceptable toxicity patients receive a second 12-week course beginning at week 16
Patients are followed every 3 months for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 25-45 patients will be accrued for this study within 5-9 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SWOG-S0116 | None | None | None |