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.
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)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Eligible patients will be assigned to a cohort and will receive intratumoral injections of Ad-CCL21-DC in conjunction with tumor sampling.
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, United States
Maximum Tolerated Dose (MTD)
Toxicity as measured by NCI Common Toxicity Criteria
Time frame: 28 Days
Disease status at days 28 and 56 days
Immune response assessment by antigen-specific interferon gamma (IFNy) Enzyme-Linked ImmunoSpot (ELISPOT) assays on days 0, 28, and 56
Time frame: 28 and 56 Days
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