Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00089063
Status:
COMPLETED
Last Update Posted:
2015-04-15
First Post:
2004-08-04
Brief Title:
Vaccine Therapy With or Without Sargramostim in Treating Patients Who Have Undergone Surgery for Melanoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Phase II Continuation Booster Trial After A Vaccine Combining TyrosinaseGP100Mart-1 Peptides Emulsified With Montanide ISA 51 and ISA 51 VG With Or Without GM-CSF For Patients With Resected Stages IIBC III And IV Melanoma
Status:
COMPLETED
Status Verified Date:
2013-10
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:
This randomized phase II trial is studying vaccine therapy and sargramostim to see how well they work compared to vaccine therapy alone in treating patients who have undergone surgery for stage IIB stage IIC stage III or stage IV melanoma Vaccines made from peptides may make the body build an immune response to kill tumor cells Colony-stimulating factors such as sargramostim increase the number of immune cells found in bone marrow or peripheral blood Combining vaccine therapy with sargramostim may make a stronger immune response
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate immune reactivity to a tyrosinase368-376 370D gp100 209-217 210MMART-1 26-35 27L peptide vaccine with Montanide ISA 51 with or without GM-CSF administered as a booster for five vaccinations over two years
OUTLINE This is a randomized parallel continuation study Patients are stratified according to response to prior vaccination response to 1 peptide vs response to 2 or more peptides Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive vaccination comprising tyrosinase peptide gp100 antigen and MART-1 antigen emulsified with Montanide ISA-51 and ISA-51 VG subcutaneously SC on day 1 of weeks 0 26 52 78 and 104 total of 5 vaccinations
Arm II Patients receive vaccination comprising tyrosinase peptide gp100 antigen and MART-1 antigen emulsified with Montanide ISA-51 and ISA-51 VG as in arm I Patients also receive sargramostim GM-CSF SC on days 1-5 of weeks 0 26 52 78 and 104
In both arms treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed at 2-4 weeks every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 40 patients 20 per treatment arm will be accrued for this study within 1 year
I To evaluate immune reactivity to a tyrosinase368-376 370D gp100 209-217 210MMART-1 26-35 27L peptide vaccine with Montanide ISA 51 with or without GM-CSF administered as a booster for five vaccinations over two years
OUTLINE This is a randomized parallel continuation study Patients are stratified according to response to prior vaccination response to 1 peptide vs response to 2 or more peptides Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive vaccination comprising tyrosinase peptide gp100 antigen and MART-1 antigen emulsified with Montanide ISA-51 and ISA-51 VG subcutaneously SC on day 1 of weeks 0 26 52 78 and 104 total of 5 vaccinations
Arm II Patients receive vaccination comprising tyrosinase peptide gp100 antigen and MART-1 antigen emulsified with Montanide ISA-51 and ISA-51 VG as in arm I Patients also receive sargramostim GM-CSF SC on days 1-5 of weeks 0 26 52 78 and 104
In both arms treatment continues in the absence of disease progression or unacceptable toxicity
Patients are followed at 2-4 weeks every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 40 patients 20 per treatment arm will be accrued for this study within 1 year
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 |
|---|---|---|---|
| 6618 | OTHER | CTEP | None |
| NCI-2012-02618 | REGISTRY | None | None |
| LAC-USC-042011 | None | None | None |
| NCI-6618 | None | None | None |
| LAC-USC-0A1033 | None | None | None |
| CDR0000378033 | None | None | None |
| 10M-03-8 | OTHER | None | None |