Vaccine Therapy in Treating Patients With Stage I, Stage II, or Stage III Non-small Cell Lung Cancer
RATIONALE: Vaccines made from a person's white blood cells and allogeneic tumor cells may make the body build an effective immune response to kill tumor cells.
PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with stage I, stage II, or stage III non-small cell lung cancer.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Autologous Dendritic Cell Vaccines in Non-small Cell Lung Cancer (NSCLC)|
- Immunologic response [ Time Frame: July/2005-Oct/2007 ] [ Designated as safety issue: No ]Measurement of antigen specific reaction through six months post-vaccine
- Comparison of clinical outcomes to historical controls [ Time Frame: July/2005-May/2012 ] [ Designated as safety issue: No ]Documentation of radiographic surveillance for recurrence or progression for 5 years post-vaccine
|Study Start Date:||October 2004|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
Biological: therapeutic autologous dendritic cells
Dendritic cells made from white blood cells obtained through out-patient leukapheresis procedure.
Vaccine given by injection under the skin in the front, upper thigh. Two vaccine injections total, given one month a part.
- Determine the immunologic effects of adjuvant vaccine therapy comprising autologous dendritic cells loaded with allogeneic non-small cell lung cancer (NSCLC) cells in patients with unresectable stage IIIA or IIIB, or resected stage I-IIIB NSCLC.
- Determine the potential clinical efficacy of this vaccine in these patients.
OUTLINE: This is an open-label study. Patients are stratified according to type of prior primary therapy (surgical vs nonsurgical).
Patients undergo leukapheresis over 3-4 hours to harvest mononuclear cells for the production of dendritic cells (DC). DC are then pulsed with allogeneic non-small cell lung cancer cells to produce an autologous dendritic cell vaccine. Patients receive vaccine intradermally once a month for 2 months in the absence of disease recurrence or unacceptable toxicity.
Patients are followed monthly for 4 months, every 6 months for 2 years, and then periodically thereafter.
PROJECTED ACCRUAL: A total of 60 patients (30 per stratum) will be accrued for this study within 3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00103116
|United States, Kentucky|
|Markey Cancer Center at University of Kentucky Chandler Medical Center|
|Lexington, Kentucky, United States, 40536-0293|
|Study Chair:||Edward Hirschowitz, MD||Lucille P. Markey Cancer Center at University of Kentucky|