Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00020358
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2001-07-11
Brief Title:
Vaccine Therapy in Treating Patients With Melanoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Randomized Comparison of Three Schedules of Peptide Immunization in Patients With Stage II or III or Completely Resected Metastatic Melanoma
Status:
COMPLETED
Status Verified Date:
2003-03
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 an effective treatment for melanoma
PURPOSE Randomized phase II trial to study the effectiveness of three vaccine therapy regimens in treating patients who have melanoma
PURPOSE Randomized phase II trial to study the effectiveness of three vaccine therapy regimens in treating patients who have melanoma
Detailed Description:
OBJECTIVES
Compare the immunologic activity of three different schedules of peptide immunization with gp100209-217 210M or gp10017-25 antigen and tyrosinase368-376 370D tyrosinase240-251 244S tyrosinase206-214 closed to accrual 110501 or tyrosinase-related protein-1 ORF31-9 peptide closed to accrual 110501 emulsified in Montanide ISA-51 in patients with melanoma at high risk for recurrence
Compare the response rate to treatment with interleukin-2 IL-2 after being immunized with this regimen with the usual response rate to IL-2 in this patient population
Determine whether an exploratory cohort of HLA-A2-positive patients demonstrate immunologic activity to immunization with 2 peptides emulsified together
OUTLINE This is a randomized study Patients are stratified according to HLA type A0201 vs A1 vs A3 vs A24 vs A31 HLA-A24 and HLA-A31 closed to accrual 110501 Patients are randomized to 1 of 3 treatment arms and are given an assigned vaccine which is emulsified in Montanide ISA-51
HLA typing
HLA-A2 gp100209-217 210M and tyrosinase368-376 370D
HLA-A1 tyrosinase240-251 244S
HLA-A3 gp10017-25
HLA-A24 tyrosinase206-214 closed to accrual 110501
HLA-A31 tyrosinase-related protein-1 ORF31-9 closed to accrual 110501
Arm I Patients receive assigned vaccine subcutaneously SC weekly for 10 weeks followed by 3 weeks of no treatment
Arm II Patients receive assigned vaccine SC on days 1 22 43 and 64
Arm III Patients receive assigned vaccine SC on days 1-4 22-25 43-46 and 64-67
Treatment in all arms repeats every 13 weeks for 4 courses in the absence of disease progression or unacceptable toxicity
After the completion of the randomized arms of HLA-A2 patients additional HLA-A2 patients receive immunization with gp100209-217 210M and tyrosinase368-376 370D emulsified in Montanide ISA-51 SC once every 3 weeks for 4 courses
Patients with progressive disease may receive interleukin-2 IV over 15 minutes every 8 hours for up to 4 days Treatment repeats every 10-14 days for at least 4 courses in the absence of disease progression or unacceptable toxicity Patients with stable disease or mixed or partial response to treatment may receive additional courses every 2 months
Patients are followed at 6 months
PROJECTED ACCRUAL A total of 324 patients 19-33 per arm for the HLA-A0201 stratum 13-16 per arm for the other 4 strata and 33 per the additional HLA-A2 cohort will be accrued for this study within 2 years HLA-A24 and HLA-A31 closed to accrual 110501
Compare the immunologic activity of three different schedules of peptide immunization with gp100209-217 210M or gp10017-25 antigen and tyrosinase368-376 370D tyrosinase240-251 244S tyrosinase206-214 closed to accrual 110501 or tyrosinase-related protein-1 ORF31-9 peptide closed to accrual 110501 emulsified in Montanide ISA-51 in patients with melanoma at high risk for recurrence
Compare the response rate to treatment with interleukin-2 IL-2 after being immunized with this regimen with the usual response rate to IL-2 in this patient population
Determine whether an exploratory cohort of HLA-A2-positive patients demonstrate immunologic activity to immunization with 2 peptides emulsified together
OUTLINE This is a randomized study Patients are stratified according to HLA type A0201 vs A1 vs A3 vs A24 vs A31 HLA-A24 and HLA-A31 closed to accrual 110501 Patients are randomized to 1 of 3 treatment arms and are given an assigned vaccine which is emulsified in Montanide ISA-51
HLA typing
HLA-A2 gp100209-217 210M and tyrosinase368-376 370D
HLA-A1 tyrosinase240-251 244S
HLA-A3 gp10017-25
HLA-A24 tyrosinase206-214 closed to accrual 110501
HLA-A31 tyrosinase-related protein-1 ORF31-9 closed to accrual 110501
Arm I Patients receive assigned vaccine subcutaneously SC weekly for 10 weeks followed by 3 weeks of no treatment
Arm II Patients receive assigned vaccine SC on days 1 22 43 and 64
Arm III Patients receive assigned vaccine SC on days 1-4 22-25 43-46 and 64-67
Treatment in all arms repeats every 13 weeks for 4 courses in the absence of disease progression or unacceptable toxicity
After the completion of the randomized arms of HLA-A2 patients additional HLA-A2 patients receive immunization with gp100209-217 210M and tyrosinase368-376 370D emulsified in Montanide ISA-51 SC once every 3 weeks for 4 courses
Patients with progressive disease may receive interleukin-2 IV over 15 minutes every 8 hours for up to 4 days Treatment repeats every 10-14 days for at least 4 courses in the absence of disease progression or unacceptable toxicity Patients with stable disease or mixed or partial response to treatment may receive additional courses every 2 months
Patients are followed at 6 months
PROJECTED ACCRUAL A total of 324 patients 19-33 per arm for the HLA-A0201 stratum 13-16 per arm for the other 4 strata and 33 per the additional HLA-A2 cohort will be accrued for this study within 2 years HLA-A24 and HLA-A31 closed to accrual 110501
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-2391 | None | None | None |
| NCI-00-C-0216 | None | None | None |