Vaccine Therapy in Treating Patients With Non-Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Registration Number
- NCT00023985
- Lead Sponsor
- Roswell Park Cancer Institute
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Roswell Park Cancer Institute🇺🇸Buffalo, New York, United States