NCT01574222

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

Intratumoral Genetic Therapy for Lung Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Non-Small Cell Lung Cancer (NSCLC)

Interventions

Type	Name	Description
BIOLOGICAL	autologous dendritic cell adenovirus CCL21 vaccine	Eligible patients will be assigned to a cohort and will receive intratumoral injections of Ad-CCL21-DC in conjunction with tumor sampling.

Timeline

• Start date: 2011-10-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2012-04-10
• Last updated: 2018-01-18

Locations

1 site across 1 country: United States