Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003274
Status:
COMPLETED
Last Update Posted:
2014-05-22
First Post:
1999-11-01
Brief Title:
Vaccine Therapy in Treating Patients With Stage II Melanoma That Can Be Removed by Surgery
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
A Randomized Phase II Trial of a Vaccine Combining Tyrosinase gp100 Peptides Emulsified With Montanide ISA 51 Alone or With a Block Co-Polymer CRL 1005 or With GM-CSF for Patients With Resected Stages IIA and IIB Melanoma Grant Application Title MART-1gp100 Immune Responses to a Melanoma Vaccine
Status:
COMPLETED
Status Verified Date:
2014-05
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 It is not yet known what preparation of vaccine therapy is most effective for treating melanoma
PURPOSE Randomized phase II trial to study the effectiveness of tyrosinasegp100 peptide vaccine in treating patients who have stage II melanoma that can be removed by surgery
PURPOSE Randomized phase II trial to study the effectiveness of tyrosinasegp100 peptide vaccine in treating patients who have stage II melanoma that can be removed by surgery
Detailed Description:
OBJECTIVES I Determine immune reactivity in HLA-A2 positive patients with resectable stage IIA or IIB melanoma treated with vaccine comprising tyrosinase peptide and gp100 antigen emulsified in Montanide ISA-51 ISA-51 alone or in combination with sargramostim GM-CSF
OUTLINE This is a randomized multicenter study Patients are stratified according to stage IIA vs IIB Patients are randomized to 1 of 2 treatment arms Arm I Patients receive vaccine comprising tyrosinase peptide and gp100 antigen emulsified in Montanide ISA-51 ISA-51 alone subcutaneously SQ once a week on weeks 0 2 4 6 10 14 18 and 26 Arm II Patients receive treatment as in arm I followed by sargramostim GM-CSF SQ for 5 days after each vaccination Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 50 patients 25 per arm will be accrued for this study within 3 years
OUTLINE This is a randomized multicenter study Patients are stratified according to stage IIA vs IIB Patients are randomized to 1 of 2 treatment arms Arm I Patients receive vaccine comprising tyrosinase peptide and gp100 antigen emulsified in Montanide ISA-51 ISA-51 alone subcutaneously SQ once a week on weeks 0 2 4 6 10 14 18 and 26 Arm II Patients receive treatment as in arm I followed by sargramostim GM-CSF SQ for 5 days after each vaccination Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 50 patients 25 per arm will be accrued for this study within 3 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-T97-0100 | None | None | None |
| LAC-USC-10M971 | None | None | None |
| LAC-USC-FDR001101 | None | None | None |