Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019890
Status:
COMPLETED
Last Update Posted:
2024-03-04
First Post:
2007-03-02
Brief Title:
Vaccine Therapy in Treating Patients With High-Risk Stage III or Completely Resected Metastatic Melanoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Randomized Study of CD34 Derived or Peripheral Monocyte Derived Dendritic Cells Pulsed With MART-1 and gp100 Melanoma Antigens in Patients With High Risk Stage III or Completely Resected Metastatic Melanoma
Status:
COMPLETED
Status Verified Date:
2024-02
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 Randomized phase II trial to study the effectiveness of vaccine therapy in treating patients who have high-risk stage III or completely resected metastatic melanoma
PURPOSE Randomized phase II trial to study the effectiveness of vaccine therapy in treating patients who have high-risk stage III or completely resected metastatic melanoma
Detailed Description:
OBJECTIVES
I Determine the immunologic activity of CD34 derived and peripheral monocyte derived dendritic cells pulsed with MART-1 and gp100 melanoma antigens in patients with high risk stage III or completely resected metastatic melanoma
PROTOCOL OUTLINE This is a randomized study Patients receive dendritic cells derived either from peripheral monocytes or CD34 cells
Dendritic cells are pulsed with MART-1 and gp100 immunodominant HLA-A201 peptides prior to infusion and are administered intralymphatically in the lower extremities for the first 2 courses Beginning with courses 3 and 4 dendritic cells are administered subcutaneously in the anterior thigh Dendritic cells are not administered to any extremity that has undergone lymph node dissection
Patients are randomized to the following treatment arms
Arm I Patients undergo leukapheresis to obtain peripheral monocytes Patients receive dendritic cells derived from peripheral mononuclear cells pulsed with MART-1 and gp100 every 4 weeks for up to 4 courses
Arm II Patients receive 5 daily subcutaneous injections of filgrastim G-CSF followed by leukapheresis on days 5 andor 6 Patients receive dendritic cells derived from CD34 cells pulsed with MART-1 and gp100 every 4 weeks for up to 4 courses
Patients are followed at 4 to 6 weeks
PROJECTED ACCRUAL
A maximum of 28 patients 14 per treatment arm will be accrued for this study within 7 months
I Determine the immunologic activity of CD34 derived and peripheral monocyte derived dendritic cells pulsed with MART-1 and gp100 melanoma antigens in patients with high risk stage III or completely resected metastatic melanoma
PROTOCOL OUTLINE This is a randomized study Patients receive dendritic cells derived either from peripheral monocytes or CD34 cells
Dendritic cells are pulsed with MART-1 and gp100 immunodominant HLA-A201 peptides prior to infusion and are administered intralymphatically in the lower extremities for the first 2 courses Beginning with courses 3 and 4 dendritic cells are administered subcutaneously in the anterior thigh Dendritic cells are not administered to any extremity that has undergone lymph node dissection
Patients are randomized to the following treatment arms
Arm I Patients undergo leukapheresis to obtain peripheral monocytes Patients receive dendritic cells derived from peripheral mononuclear cells pulsed with MART-1 and gp100 every 4 weeks for up to 4 courses
Arm II Patients receive 5 daily subcutaneous injections of filgrastim G-CSF followed by leukapheresis on days 5 andor 6 Patients receive dendritic cells derived from CD34 cells pulsed with MART-1 and gp100 every 4 weeks for up to 4 courses
Patients are followed at 4 to 6 weeks
PROJECTED ACCRUAL
A maximum of 28 patients 14 per treatment arm will be accrued for this study within 7 months
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-99-C-0132 | None | None | None |