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Brief Title: A Vaccine Trial for Patients With Stage IIIB, IV, or Recurrent Non-Small Cell Lung Cancer
Official Title: Intratumoral Genetic Therapy for Lung Cancer
Study ID: NCT01574222
Brief Summary: The purpose of this study is to determine the dose that the vaccine can be given safely to patients when injected directly into the lung tumor, without any serious side effects.
Detailed Description: Primary - to determine the safety, toxicity, and Maximum Tolerated Dose (MTD) of autologous dendritic cell-adenovirus chemokine (C-C motif) ligand 21 (CCL21) vaccine administered as an intratumoral injection in treating patients with stage IIIB, IV, or recurrent non-small cell lung cancer Secondary * to determine the biologic and clinical responses to therapy * to determine treatment-related toxicity using the NCI Common Toxicity Criteria * to identify the maximum tolerated dose (MTD) * to monitor patients for evidence of autologous dendritic cell-adenovirus CCL21 vaccine-induced cytokines and antigen-specific immune responses * to detect immune responses to tumor-associated antigens and vector * to assess patients for objective signs of tumor regression (RECIST criteria)
Minimum Age: 21 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
VA Greater Los Angeles Healthcare System, West Los Angeles, CA, West Los Angeles, California, United States
Name: Steven Dubinett, MD
Affiliation: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Role: PRINCIPAL_INVESTIGATOR