Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00032045
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
2002-03-08
Brief Title:
Vaccine Therapy and Monoclonal Antibody Therapy in Treating Patients With Stage IV Melanoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
An Open-label Study Of MDX-010 In Combination With gp100 Peptides Emulsified With Montanide ISA 51 In The Treatment Of Patients With Stage IV Melanoma
Status:
COMPLETED
Status Verified Date:
2003-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Vaccines made from peptides may make the body build an immune response to kill tumor cells Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Combining vaccine therapy with a monoclonal antibody may cause a stronger immune response and kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining vaccine therapy with monoclonal antibody therapy in treating patients who have stage IV melanoma
PURPOSE Phase II trial to study the effectiveness of combining vaccine therapy with monoclonal antibody therapy in treating patients who have stage IV melanoma
Detailed Description:
OBJECTIVES
Determine the clinical response in patients with stage IV melanoma when treated with anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody combined with gp100209-217 and gp100280-288 peptides emulsified in Montanide ISA-51
Determine a safety and adverse event profile of this regimen in these patients
Determine improved immunologic response in patients treated with this regimen
OUTLINE This is an open-label study
Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody IV over 90 minutes immediately followed by gp100209-217 and gp100280-288 peptides emulsified in Montanide ISA-51 subcutaneously on days 1 22 43 and 64 Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed at 3 weeks every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 68 patients will be accrued for this study within 2 years
Determine the clinical response in patients with stage IV melanoma when treated with anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody combined with gp100209-217 and gp100280-288 peptides emulsified in Montanide ISA-51
Determine a safety and adverse event profile of this regimen in these patients
Determine improved immunologic response in patients treated with this regimen
OUTLINE This is an open-label study
Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody IV over 90 minutes immediately followed by gp100209-217 and gp100280-288 peptides emulsified in Montanide ISA-51 subcutaneously on days 1 22 43 and 64 Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed at 3 weeks every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL A total of 68 patients will be accrued for this study within 2 years
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-5743 | None | None | None |
| NCI-02-C-0106H | None | None | None |