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Brief Title: Vaccine Therapy in Treating Patients With Non-Small Cell Lung Cancer
Official Title: Vaccination With Autologous Tumor Lysate-Pulsed Dendritic Cells - Phase I
Study ID: NCT00023985
Brief Summary: 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.
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 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Roswell Park Cancer Institute, Buffalo, New York, United States
Name: Timothy M. Anderson, MD
Affiliation: Roswell Park Cancer Institute
Role: STUDY_CHAIR