A Vaccine Trial for Patients With Stage IIIB, IV, or Recurrent Non-Small Cell Lung Cancer
Last updated on July 2021Recruitment
- 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