Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00295958
Status:
COMPLETED
Last Update Posted:
2012-06-14
First Post:
2006-02-23
Brief Title:
LMB-2 Immunotoxin and Vaccine Therapy in Treating Patients With Metastatic Melanoma That Cannot Be Removed By Surgery
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Phase II Evaluation of Peptide Immunization and LMB-2 in Metastatic Melanoma
Status:
COMPLETED
Status Verified Date:
2012-06
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 The LMB-2 immunotoxin can find tumor cells and kill them without harming normal cells Vaccines made from peptides may help the body build an effective immune response to kill tumor cells Giving LMB-2 immunotoxin together with vaccine therapy may kill more tumor cells
PURPOSE This phase II trial is studying how well giving LMB-2 immunotoxin together with vaccine therapy works in treating patients with metastatic melanoma that cannot be removed by surgery
PURPOSE This phase II trial is studying how well giving LMB-2 immunotoxin together with vaccine therapy works in treating patients with metastatic melanoma that cannot be removed by surgery
Detailed Description:
OBJECTIVES
Primary
Determine objective clinical response in patients with progressive unresectable metastatic melanoma treated with recombinant LMB-2 immunotoxin and peptide vaccination comprising gp100209-217 210M antigen MART-127-35 antigen and Montanide ISA-51
Secondary
Determine changes in levels of CD4 CD25 regulatory T cells in peripheral blood before and after treatment in patients treated with this regimen
Determine the ability of recombinant immunotoxin LMB-2 to augment peptide vaccination in these patients
Determine the toxicity profile of this regimen in these patients
OUTLINE Patients receive LMB-2 immunotoxin IV over 30 minutes twice on days 1-3 Patients then receive peptide vaccinations comprising gp100209-217 210M antigen emulsified in Montanide ISA-51 subcutaneously SC and MART-127-35 vaccine emulsified in Montanide ISA-51 SC on days 4 5 6 and 24-27 course 1 After week 8 patients achieving tumor response may receive 1 additional course in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically in the absence of disease progression
PROJECTED ACCRUAL A total of 26 patients will be accrued for this study
Primary
Determine objective clinical response in patients with progressive unresectable metastatic melanoma treated with recombinant LMB-2 immunotoxin and peptide vaccination comprising gp100209-217 210M antigen MART-127-35 antigen and Montanide ISA-51
Secondary
Determine changes in levels of CD4 CD25 regulatory T cells in peripheral blood before and after treatment in patients treated with this regimen
Determine the ability of recombinant immunotoxin LMB-2 to augment peptide vaccination in these patients
Determine the toxicity profile of this regimen in these patients
OUTLINE Patients receive LMB-2 immunotoxin IV over 30 minutes twice on days 1-3 Patients then receive peptide vaccinations comprising gp100209-217 210M antigen emulsified in Montanide ISA-51 subcutaneously SC and MART-127-35 vaccine emulsified in Montanide ISA-51 SC on days 4 5 6 and 24-27 course 1 After week 8 patients achieving tumor response may receive 1 additional course in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically in the absence of disease progression
PROJECTED ACCRUAL A total of 26 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 |
|---|---|---|---|
| 06-C-0041 | None | None | None |
| NCI-7542 | None | None | None |
| NCI-P6702 | None | None | None |
| CDR0000462165 | None | None | None |