Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00089193
Status:
COMPLETED
Last Update Posted:
2014-12-23
First Post:
2004-08-04
Brief Title:
Vaccine Therapy With or Without Sargramostim in Treating Patients With Stage IIB Stage IIC Stage III or Stage IV Melanoma
Sponsor:
Craig L Slingluff Jr
Organization:
University of Virginia
Study Overview
Official Title:
Evaluation of GM-CSF-in-Adjuvant and the Number of Vaccine Sites on Immunization With Multiple Synthetic Melanoma Peptides
Status:
COMPLETED
Status Verified Date:
2014-12
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 Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood Combining vaccine therapy with sargramostim may cause a stronger immune response and kill more tumor cells
PURPOSE 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 with stage II B stage IIC stage III or stage IV melanoma
PURPOSE 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 with stage II B stage IIC stage III or stage IV melanoma
Detailed Description:
OBJECTIVES
Compare immune response in patients with stage IIB-IV melanoma treated with vaccination comprising multiple synthetic melanoma peptides and Montanide ISA-51 with vs without sargramostim GM-CSF
Compare immune response in patients treated with these vaccinations administered at 1 vs 2 sites
OUTLINE This is a randomized open-label study Patients are randomized to 1 of 4 treatment arms
Arm I Patients receive vaccination comprising multiple synthetic melanoma peptides and Montanide ISA-51 at 1 injection site
Arm II Patients receive vaccination comprising multiple synthetic melanoma peptides and Montanide ISA-51 at 2 injection sites
Arm III Patients receive vaccination comprising multiple synthetic melanoma peptides Montanide ISA-51 and sargramostim GM-CSF at 1 injection site
Arm IV Patients receive vaccination comprising multiple synthetic melanoma peptides Montanide ISA-51 and GM-CSF at 2 injection sites
In all arms treatment repeats once weekly for 6 weeks Patients return for booster vaccinations at weeks 12 26 39 and 52
PROJECTED ACCRUAL A maximum of 124 patients will be accrued for this study
Compare immune response in patients with stage IIB-IV melanoma treated with vaccination comprising multiple synthetic melanoma peptides and Montanide ISA-51 with vs without sargramostim GM-CSF
Compare immune response in patients treated with these vaccinations administered at 1 vs 2 sites
OUTLINE This is a randomized open-label study Patients are randomized to 1 of 4 treatment arms
Arm I Patients receive vaccination comprising multiple synthetic melanoma peptides and Montanide ISA-51 at 1 injection site
Arm II Patients receive vaccination comprising multiple synthetic melanoma peptides and Montanide ISA-51 at 2 injection sites
Arm III Patients receive vaccination comprising multiple synthetic melanoma peptides Montanide ISA-51 and sargramostim GM-CSF at 1 injection site
Arm IV Patients receive vaccination comprising multiple synthetic melanoma peptides Montanide ISA-51 and GM-CSF at 2 injection sites
In all arms treatment repeats once weekly for 6 weeks Patients return for booster vaccinations at weeks 12 26 39 and 52
PROJECTED ACCRUAL A maximum of 124 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 |
|---|---|---|---|
| MDA-2003-0720 | None | None | None |
| UVACC-MEL-43 | None | None | None |
| FCCC-03045 | None | None | None |