Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00089206
Status:
COMPLETED
Last Update Posted:
2014-12-19
First Post:
2004-08-04
Brief Title:
Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
Official Title:
Vaccination With Synthetic Melanoma Peptides Administered With GM-CSF-in-Adjuvant in Patients With Advanced Melanoma
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
PURPOSE This phase II trial is studying how well vaccine therapy works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery
PURPOSE This phase II trial is studying how well vaccine therapy works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery
Detailed Description:
OBJECTIVES
Determine the antitumor immune response in patients with unresectable stage III or IV melanoma treated with vaccine comprising multiple synthetic melanoma peptides sargramostim GM-CSF and Montanide ISA-51
OUTLINE Patients receive vaccine comprising multiple synthetic melanoma peptides sargramostim GM-CSF and Montanide ISA-51 on days 1 8 15 29 36 and 43 Patients undergo removal of the lymph node draining the vaccination site on day 22 to assess immune response
PROJECTED ACCRUAL A maximum of 29 patients will be accrued for this study
Determine the antitumor immune response in patients with unresectable stage III or IV melanoma treated with vaccine comprising multiple synthetic melanoma peptides sargramostim GM-CSF and Montanide ISA-51
OUTLINE Patients receive vaccine comprising multiple synthetic melanoma peptides sargramostim GM-CSF and Montanide ISA-51 on days 1 8 15 29 36 and 43 Patients undergo removal of the lymph node draining the vaccination site on day 22 to assess immune response
PROJECTED ACCRUAL A maximum of 29 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-24802 | None | None | None |
| UVACC-MEL-42 | None | None | None |