NCT00023985

Vaccine Therapy in Treating Patients With Non-Small Cell Lung Cancer

Vaccination With Autologous Tumor Lysate-Pulsed Dendritic Cells - Phase I

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	autologous tumor cell vaccine
BIOLOGICAL	therapeutic autologous dendritic cells
PROCEDURE	conventional surgery

Timeline

• Start date: 2001-01-01
• Primary completion: 2003-07-01
• Completion: 2003-08-01
• First posted: 2003-01-27
• Last updated: 2011-03-07

Locations

1 site across 1 country: United States