Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00103116
Status:
COMPLETED
Last Update Posted:
2017-04-04
First Post:
2005-02-07
Brief Title:
Vaccine Therapy in Treating Patients With Stage I Stage II or Stage III Non-small Cell Lung Cancer
Sponsor:
Edward Hirschowitz
Organization:
University of Kentucky
Study Overview
Official Title:
Autologous Dendritic Cell Vaccines in Non-small Cell Lung Cancer NSCLC
Status:
COMPLETED
Status Verified Date:
2017-03
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 white blood cells and allogeneic tumor cells may make the body build an effective immune response to kill tumor cells
PURPOSE This phase II trial is studying how well vaccine therapy works in treating patients with stage I stage II or stage III non-small cell lung cancer
PURPOSE This phase II trial is studying how well vaccine therapy works in treating patients with stage I stage II or stage III non-small cell lung cancer
Detailed Description:
OBJECTIVES
Determine the immunologic effects of adjuvant vaccine therapy comprising autologous dendritic cells loaded with allogeneic non-small cell lung cancer NSCLC cells in patients with unresectable stage IIIA or IIIB or resected stage I-IIIB NSCLC
Determine the potential clinical efficacy of this vaccine in these patients
OUTLINE This is an open-label study Patients are stratified according to type of prior primary therapy surgical vs nonsurgical
Patients undergo leukapheresis over 3-4 hours to harvest mononuclear cells for the production of dendritic cells DC DC are then pulsed with allogeneic non-small cell lung cancer cells to produce an autologous dendritic cell vaccine Patients receive vaccine intradermally once a month for 2 months in the absence of disease recurrence or unacceptable toxicity
Patients are followed monthly for 4 months every 6 months for 2 years and then periodically thereafter
PROJECTED ACCRUAL A total of 60 patients 30 per stratum will be accrued for this study within 3 years
Determine the immunologic effects of adjuvant vaccine therapy comprising autologous dendritic cells loaded with allogeneic non-small cell lung cancer NSCLC cells in patients with unresectable stage IIIA or IIIB or resected stage I-IIIB NSCLC
Determine the potential clinical efficacy of this vaccine in these patients
OUTLINE This is an open-label study Patients are stratified according to type of prior primary therapy surgical vs nonsurgical
Patients undergo leukapheresis over 3-4 hours to harvest mononuclear cells for the production of dendritic cells DC DC are then pulsed with allogeneic non-small cell lung cancer cells to produce an autologous dendritic cell vaccine Patients receive vaccine intradermally once a month for 2 months in the absence of disease recurrence or unacceptable toxicity
Patients are followed monthly for 4 months every 6 months for 2 years and then periodically thereafter
PROJECTED ACCRUAL A total of 60 patients 30 per stratum will be accrued for this study within 3 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 |
|---|---|---|---|
| R21CA091624 | NIH | None | None |
| UKMC-IRB-0391-F2R | OTHER | None | None |
| UKMC-CTRF-G-01-009 | OTHER_GRANT | Cancer Treatment Research Foundation | httpsreporternihgovquickSearchR21CA091624 |