Vaccine Therapy in Treating Patients With Non-Small Cell Lung Cancer
RATIONALE: Vaccines made from a person's 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.
Biological: autologous tumor cell vaccine
Biological: therapeutic autologous dendritic cells
Procedure: conventional surgery
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Vaccination With Autologous Tumor Lysate-Pulsed Dendritic Cells - Phase I|
|Study Start Date:||January 2001|
|Study Completion Date:||August 2003|
|Primary Completion Date:||July 2003 (Final data collection date for primary outcome measure)|
- 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 and/or 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00023985
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Study Chair:||Timothy M. Anderson, MD||Roswell Park Cancer Institute|