Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017355
Status:
UNKNOWN
Last Update Posted:
2013-09-17
First Post:
2001-06-06
Brief Title:
Vaccine Therapy in Treating Patients With Metastatic Melanoma
Sponsor:
Baylor Health Care System
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Mature Dendritic Cell Immunotherapy Of Metastatic Melanoma- A Phase I Trial
Status:
UNKNOWN
Status Verified Date:
2003-03
Last Known Status:
ACTIVE_NOT_RECRUITING
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 made from a patients white blood cells mixed with tumor antigens may make the body build an immune response to kill tumor cells
PURPOSE Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma
PURPOSE Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma
Detailed Description:
OBJECTIVES
Determine the safety and tolerability of antigen-pulsed dendritic cell vaccine in patients with metastatic melanoma
Determine the longevity of melanoma-specific immunity in patients treated with this regimen
Perform serial analysis of T-cell and B-cell function in patients treated with this regimen
OUTLINE Patients receive filgrastim G-CSF subcutaneously SC once daily on days 1-6 or 1-7 Patients undergo apheresis on days 6 and 7 or 6-8 to obtain peripheral blood mononuclear cells PBMC PBMC are processed for CD34 cell isolation These autologous CD34 hematopoietic progenitor cells are cultured to generate dendritic cells DC DC are then pulsed with endotoxin-free keyhole limpet hemocyanin and HLA-A2-01 restricted flu-matrix peptides derived from melanoma-associated tumor antigens MART-127-35 gp100209-217 and MAGE-3 Antigen-pulsed DC are incubated with interferon alfa to induce DC maturation
Patients receive priming injections of antigen-pulsed DC vaccine SC once every 2 weeks for 8 weeks Treatment repeats at 2 3 4 and 5 months after the last priming injection in the absence of unacceptable toxicity or disease progression
Patients are followed at 2 and 4 weeks and then every 3 months for 15 years
PROJECTED ACCRUAL A total of 18 patients will be accrued for this study
Determine the safety and tolerability of antigen-pulsed dendritic cell vaccine in patients with metastatic melanoma
Determine the longevity of melanoma-specific immunity in patients treated with this regimen
Perform serial analysis of T-cell and B-cell function in patients treated with this regimen
OUTLINE Patients receive filgrastim G-CSF subcutaneously SC once daily on days 1-6 or 1-7 Patients undergo apheresis on days 6 and 7 or 6-8 to obtain peripheral blood mononuclear cells PBMC PBMC are processed for CD34 cell isolation These autologous CD34 hematopoietic progenitor cells are cultured to generate dendritic cells DC DC are then pulsed with endotoxin-free keyhole limpet hemocyanin and HLA-A2-01 restricted flu-matrix peptides derived from melanoma-associated tumor antigens MART-127-35 gp100209-217 and MAGE-3 Antigen-pulsed DC are incubated with interferon alfa to induce DC maturation
Patients receive priming injections of antigen-pulsed DC vaccine SC once every 2 weeks for 8 weeks Treatment repeats at 2 3 4 and 5 months after the last priming injection in the absence of unacceptable toxicity or disease progression
Patients are followed at 2 and 4 weeks and then every 3 months for 15 years
PROJECTED ACCRUAL A total of 18 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-4170 | None | None | None |
| BAYUMC-000048 | None | None | None |