Recruitment

Recruitment Status
Terminated
Estimated Enrollment
21

Summary

Conditions
Non - Small Cell Lung Cancer NSCLC
Type
Interventional
Phase
Phase 1
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Masking Description: No maskingPrimary Purpose: Treatment

Participation Requirements

Age
Between 21 years and 125 years
Gender
Both males and females

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 ...

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)

Tracking Information

NCT #
NCT01574222
Collaborators
  • Jonsson Comprehensive Cancer Center
  • National Cancer Institute (NCI)
Investigators
Principal Investigator: Steven Dubinett, MD VA Greater Los Angeles Healthcare System, West Los Angeles, CA