Vaccine Therapy in Treating Patients With Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00023985|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 7, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Biological: autologous tumor cell vaccine Biological: therapeutic autologous dendritic cells Procedure: conventional surgery||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Vaccination With Autologous Tumor Lysate-Pulsed Dendritic Cells - Phase I|
|Study Start Date :||January 2001|
|Actual Primary Completion Date :||July 2003|
|Actual Study Completion Date :||August 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|