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Carcinoma, Non-Small-Cell Lung

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Lung Diseases

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Carcinoma, Bronchogenic

Respiratory Tract Neoplasms

Respiratory Tract Diseases

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Vaccines

Eligible patients will be assigned to a cohort and will receive intratumoral injections of Ad-CCL21-DC in conjunction with tumor sampling

Eligible patients will be assigned to a cohort and will receive intratumoral injections of Ad-CCL21-DC in conjunction with tumor sampling.

autologous dendritic cell adenovirus CCL21 vaccine

Steven Dubinett, MD

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)

A Vaccine Trial for Patients With Stage IIIB, IV, or Recurrent Non-Small Cell Lung Cancer

Intratumoral Genetic Therapy for Lung Cancer

Toxicity as measured by NCI Common Toxicity Criteria

Immune response assessment by antigen-specific interferon gamma (IFNy) Enzyme-Linked ImmunoSpot (ELISPOT) assays on days 0, 28, and 56

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Vaccine Trial for Patients With Stage IIIB, IV, or Recurrent Non-Small Cell Lung Cancer	NCT01574222	Non-Small Cell ...	autologous dend...	21 Years -	VA Office of Research and Development
A Vaccine Trial for Patients With Stage IIIB, IV, or Recurrent Non-Small Cell Lung Cancer	NCT01574222	Non-Small Cell ...	autologous dend...	21 Years -	VA Office of Research and Development
A Vaccine Trial for Patients With Stage IIIB, IV, or Recurrent Non-Small Cell Lung Cancer	NCT01574222	Non-Small Cell ...	autologous dend...	21 Years -	VA Office of Research and Development

Spots Global Cancer Trial Database for autologous dendritic cell adenovirus ccl21 vaccine