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

Phase 1 Terminated 1 enrolled VA Office of Research and Development Jonsson Comprehensive Cancer Center · collab National Cancer Institute (NCI) · collab

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2011-10-01
Primary completion: 2017-03-01
Completion: 2017-03-01

Outcome

Outcome not reported

Stopped: “Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)”

Publications

Lee JM, Lee MH, Garon E, Goldman JW, Salehi-Rad R, Baratelli FE, Schaue D, Wang G, Rosen F, Yanagawa J, Walser TC, Lin Y, Park SJ, Adams S, Marincola FM, Tumeh PC, Abtin F, Suh R, Reckamp KL, Lee G, Wallace WD, Lee S, Zeng G, Elashoff DA, Sharma S, Dubinett SM. Phase I Trial of Intratumoral Injection of CCL21 Gene-Modified Dendritic Cells in Lung Cancer Elicits Tumor-Specific Immune Responses and CD8+ T-cell Infiltration. Clin Cancer Res. 2017 Aug 15;23(16):4556-4568. doi: 10.1158/1078-0432.CCR-16-2821. Epub 2017 May 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ad-CCL21-DC	Vaccine	1e+06 cells	Other
Subject	Ad-CCL21-DC	Vaccine	5e+06 cells	Other
Subject	Ad-CCL21-DC	Vaccine	1e+07 cells	Other
Subject	Ad-CCL21-DC	Vaccine	3e+07 cells	Other