Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00072085
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2003-11-04
Brief Title:
Immunization With gp100 Protein Vaccine in Treating Patients With Metastatic Melanoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Immunization Of Patients With Metastatic Melanoma Using A Recombinant GP100 Protein 184V And A Class I Restricted Peptide From The GP100 Antigen
Status:
COMPLETED
Status Verified Date:
2005-05
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 Vaccines may make the body build an immune response to kill tumor cells
PURPOSE This randomized phase II trial is studying immunization using two different gp100 protein vaccines to compare how well they work in treating patients with metastatic melanoma
PURPOSE This randomized phase II trial is studying immunization using two different gp100 protein vaccines to compare how well they work in treating patients with metastatic melanoma
Detailed Description:
OBJECTIVES
Primary
Compare the clinical response in patients with metastatic melanoma immunized with recombinant gp100 protein 184V emulsified in Montanide ISA-51 with or without gp100209-217 210M peptide
Secondary
Compare the toxicity profile of these immunizations in these patients
OUTLINE This is a randomized study Patients are assigned to 1 of 2 cohorts according to HLA-A20201 status Patients assigned to cohort 1 are then randomized to 1 of 2 treatment arms
Cohort 1 HLA-A20201-positive patients Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive immunization comprising recombinant gp100 protein 184V emulsified in Montanide ISA-51 subcutaneously SC on days 1 22 43 and 64 1 course
Arm II Patients receive immunization comprising recombinant gp100 protein 184V and gp100209-217 210M peptide emulsified in Montanide ISA-51 SC on days 1 22 43 and 64 1 course
Cohort 2 HLA-A20201-negative patients Patients receive immunization as in cohort 1 arm I
In both cohorts treatment continues in the absence of rapid disease progression or unacceptable toxicity
In both cohorts patients are evaluated 3-4 weeks after the fourth immunization Patients achieving stable disease or a partial response receive retreatment according to their assigned cohort Patients with progressive disease who are eligible for interleukin-2 IL-2 receive retreatment according to their assigned cohort AND high-dose IL-2 IV over 15 minutes 3 times daily on days 2-5 23-26 44-47 and 65-68 1 course Patients receive up to 3 retreatment courses Patients achieving a complete response CR receive 1 retreatment course beyond CR Patients with progressive disease who are ineligible for IL-2 administration are removed from the study
PROJECTED ACCRUAL A total of 45-75 patients 30-50 for cohort 1 15-25 per treatment arm and 15-25 for cohort 2 will be accrued for this study within 3 years
Primary
Compare the clinical response in patients with metastatic melanoma immunized with recombinant gp100 protein 184V emulsified in Montanide ISA-51 with or without gp100209-217 210M peptide
Secondary
Compare the toxicity profile of these immunizations in these patients
OUTLINE This is a randomized study Patients are assigned to 1 of 2 cohorts according to HLA-A20201 status Patients assigned to cohort 1 are then randomized to 1 of 2 treatment arms
Cohort 1 HLA-A20201-positive patients Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive immunization comprising recombinant gp100 protein 184V emulsified in Montanide ISA-51 subcutaneously SC on days 1 22 43 and 64 1 course
Arm II Patients receive immunization comprising recombinant gp100 protein 184V and gp100209-217 210M peptide emulsified in Montanide ISA-51 SC on days 1 22 43 and 64 1 course
Cohort 2 HLA-A20201-negative patients Patients receive immunization as in cohort 1 arm I
In both cohorts treatment continues in the absence of rapid disease progression or unacceptable toxicity
In both cohorts patients are evaluated 3-4 weeks after the fourth immunization Patients achieving stable disease or a partial response receive retreatment according to their assigned cohort Patients with progressive disease who are eligible for interleukin-2 IL-2 receive retreatment according to their assigned cohort AND high-dose IL-2 IV over 15 minutes 3 times daily on days 2-5 23-26 44-47 and 65-68 1 course Patients receive up to 3 retreatment courses Patients achieving a complete response CR receive 1 retreatment course beyond CR Patients with progressive disease who are ineligible for IL-2 administration are removed from the study
PROJECTED ACCRUAL A total of 45-75 patients 30-50 for cohort 1 15-25 per treatment arm and 15-25 for cohort 2 will be accrued for this study within 3 years
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 |
|---|---|---|---|
| NCI-6210 | None | None | None |
| NCI-03-C-0299 | None | None | None |