Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025181
Status:
COMPLETED
Last Update Posted:
2014-05-22
First Post:
2001-10-11
Brief Title:
Monoclonal Antibody and Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Has Been Removed During Surgery
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
An Open-label Study Of MDX-CTLA4 In Combination With Tyrosinasegp100MART-1 Peptides Emulsified With Montanide ISA 51 In The Treatment Of Patients With Resected Stage III Or Stage IV Melanoma
Status:
COMPLETED
Status Verified Date:
2014-05
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 Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Vaccines made from a persons cancer cells may make the body build an immune response to kill tumor cells
PURPOSE Phase I trial to study the effectiveness of combining monoclonal antibody therapy and vaccine therapy in treating patients who have stage III or stage IV melanoma that has been removed during surgery
PURPOSE Phase I trial to study the effectiveness of combining monoclonal antibody therapy and vaccine therapy in treating patients who have stage III or stage IV melanoma that has been removed during surgery
Detailed Description:
OBJECTIVES
Determine the safety and adverse event profile of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody combined with tyrosinase368-376 gp100209-217 and MART-126-35 peptides emulsified in Montanide ISA-51 in patients with resected stage III or IV melanoma
Determine if this regimen causes antigen-specific T-cell activation in these patients
Determine the clearance profile of this regimen in these patients
Assess the development of host immune response in patients treated with this regimen
OUTLINE This is a dose-escalation study of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody MDX-CTLA4
Patients receive tyrosinase368-376 gp100209-217 and MART-126-35 peptides emulsified in Montanide ISA-51 subcutaneously followed by MDX-CTLA4 IV over 90 minutes at 0 1 2 3 4 5 8 and 11 months in the absence of disease progression or unacceptable toxicity
Cohorts of at least 6 patients receive escalating doses of MDX-CTLA4 until the maximum tolerated dose is determined
Patients are followed every 3 months for 1 year every 6 months for 2 years and then annually thereafter until disease progression
PROJECTED ACCRUAL A total of 18 patients will be accrued for this study
Determine the safety and adverse event profile of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody combined with tyrosinase368-376 gp100209-217 and MART-126-35 peptides emulsified in Montanide ISA-51 in patients with resected stage III or IV melanoma
Determine if this regimen causes antigen-specific T-cell activation in these patients
Determine the clearance profile of this regimen in these patients
Assess the development of host immune response in patients treated with this regimen
OUTLINE This is a dose-escalation study of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody MDX-CTLA4
Patients receive tyrosinase368-376 gp100209-217 and MART-126-35 peptides emulsified in Montanide ISA-51 subcutaneously followed by MDX-CTLA4 IV over 90 minutes at 0 1 2 3 4 5 8 and 11 months in the absence of disease progression or unacceptable toxicity
Cohorts of at least 6 patients receive escalating doses of MDX-CTLA4 until the maximum tolerated dose is determined
Patients are followed every 3 months for 1 year every 6 months for 2 years and then annually thereafter until disease progression
PROJECTED ACCRUAL A total of 18 patients 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 |
|---|---|---|---|
| NCI-4210 | None | None | None |
| LAC-USC-10M004 | None | None | None |
| MDX-MDXCTLA4-03 | None | None | None |