Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00089219
Status:
COMPLETED
Last Update Posted:
2014-11-20
First Post:
2004-08-04
Brief Title:
Vaccine Therapy in Treating Patients With Stage IIIB Stage IIIC or Stage IV Melanoma
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
Official Title:
Vaccination With Multiple Synthetic Melanoma Peptides Recognized by Helper T-Cells in Patients With Advanced Melanoma
Status:
COMPLETED
Status Verified Date:
2014-11
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 III trial is studying three different doses of a vaccine and comparing them to see how well they work in treating patients with stage IIIB stage IIIC or stage IV melanoma
PURPOSE This randomized phase III trial is studying three different doses of a vaccine and comparing them to see how well they work in treating patients with stage IIIB stage IIIC or stage IV melanoma
Detailed Description:
OBJECTIVES
Determine the immune response in patients with stage IIIB IIIC or IV melanoma treated with vaccine comprising multiple synthetic melanoma peptides Montanide ISA-51 and sargramostim GM-CSF
OUTLINE This is a randomized study Patients are randomized to 1 of 3 treatment arms
Arm I Patients receive vaccine comprising low-dose multiple synthetic melanoma peptides Montanide ISA-51 and sargramostim GM-CSF on days 1 8 15 29 36 and 43
Arm II Patients receive vaccine comprising medium-dose multiple synthetic melanoma peptides Montanide ISA-51 and GM-CSF as in arm I
Arm III Patients receive vaccine comprising high-dose multiple synthetic melanoma peptides Montanide ISA-51 and GM-CSF as in arm I
On day 22 the lymph node draining the vaccination site is removed to determine whether the immune system is responding to the vaccine
PROJECTED ACCRUAL A maximum of 38 patients will be accrued for this study
Determine the immune response in patients with stage IIIB IIIC or IV melanoma treated with vaccine comprising multiple synthetic melanoma peptides Montanide ISA-51 and sargramostim GM-CSF
OUTLINE This is a randomized study Patients are randomized to 1 of 3 treatment arms
Arm I Patients receive vaccine comprising low-dose multiple synthetic melanoma peptides Montanide ISA-51 and sargramostim GM-CSF on days 1 8 15 29 36 and 43
Arm II Patients receive vaccine comprising medium-dose multiple synthetic melanoma peptides Montanide ISA-51 and GM-CSF as in arm I
Arm III Patients receive vaccine comprising high-dose multiple synthetic melanoma peptides Montanide ISA-51 and GM-CSF as in arm I
On day 22 the lymph node draining the vaccination site is removed to determine whether the immune system is responding to the vaccine
PROJECTED ACCRUAL A maximum of 38 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 |
|---|---|---|---|
| UVACC-28502 | None | None | None |
| UVACC-MEL-41 | None | None | None |