Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00023985
Status:
COMPLETED
Last Update Posted:
2011-03-07
First Post:
2001-09-13
Brief Title:
Vaccine Therapy in Treating Patients With Non-Small Cell Lung Cancer
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
Vaccination With Autologous Tumor Lysate-Pulsed Dendritic Cells - Phase I
Status:
COMPLETED
Status Verified Date:
2011-03
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 made from a persons tumor cells and white blood cells 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 non-small cell lung cancer
PURPOSE Phase I trial to study the effectiveness of vaccine therapy in treating patients who have non-small cell lung cancer
Detailed Description:
OBJECTIVES
Determine the safety and feasibility of immunization with autologous tumor lysate-pulsed dendritic cell vaccine in patients with non-small cell lung cancer
Determine the immunologic response in patients treated with this vaccine
OUTLINE Patients undergo surgery to remove all or most of the gross evidence of tumor Two months after surgery or 4 months if chemotherapy andor radiotherapy are required patients undergo leukapheresis Peripheral blood mononuclear cells are isolated and cultured with interleukin-4 and sargramostim GM-CSF to generate dendritic cells DC DC are then pulsed with tumor lysate prepared from previously removed tumor Patients receive autologous tumor lysate-pulsed DC vaccine subcutaneously twice 4 weeks apart
Patients are followed every 4 months for 2 years every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 10 patients will be accrued for this study within 2 years
Determine the safety and feasibility of immunization with autologous tumor lysate-pulsed dendritic cell vaccine in patients with non-small cell lung cancer
Determine the immunologic response in patients treated with this vaccine
OUTLINE Patients undergo surgery to remove all or most of the gross evidence of tumor Two months after surgery or 4 months if chemotherapy andor radiotherapy are required patients undergo leukapheresis Peripheral blood mononuclear cells are isolated and cultured with interleukin-4 and sargramostim GM-CSF to generate dendritic cells DC DC are then pulsed with tumor lysate prepared from previously removed tumor Patients receive autologous tumor lysate-pulsed DC vaccine subcutaneously twice 4 weeks apart
Patients are followed every 4 months for 2 years every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 10 patients will be accrued for this study within 2 years
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-G01-2007 | None | None | None |
| RPCI-RP-9907 | None | None | None |