Vaccine Therapy in Treating Patients With Stage I, Stage II, or Stage III Non-small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00103116|
Recruitment Status : Completed
First Posted : February 8, 2005
Results First Posted : April 4, 2017
Last Update Posted : April 4, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Biological: autologous dendritic cell cancer vaccine||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Autologous Dendritic Cell Vaccines in Non-small Cell Lung Cancer (NSCLC)|
|Study Start Date :||October 2004|
|Actual Primary Completion Date :||April 2008|
|Actual Study Completion Date :||April 2008|
Experimental: Autologous dendritic cell cancer vaccine
Open label nonrandomized
Biological: autologous dendritic cell cancer vaccine
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.
- Number of Participants Showing Immunologic Response to Vaccine Within Six Months of Immunization [ Time Frame: six months post vaccine ]Antigen specific reaction is measured serially in blood of each participant prior to and through six months post-vaccine. Increase in levels of specific T cell activity from pre vaccine to post vaccine serve as primary measures of an individual's response to vaccine. The number (relative percent) of participants achieving immunologic response to vaccine within 6 month of immunization was the dominant metric of vaccine activity within the study population.
- Number of Participants Alive Five Years Post Vaccine [ Time Frame: five years post vaccine ]Documentation of radiographic surveillance for recurrence or progression for 5 years post-vaccine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|