Vaccination With Autologous Tumor Lysate-Pulsed Dendritic Cells - Phase I
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.
Interventional
Primary Purpose: Treatment
Timothy M. Anderson, MD
Study Chair
Roswell Park Cancer Institute
United States: Federal Government
CDR0000068881
NCT00023985
January 2001
August 2003
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |