Safety and Efficacy of DC Vaccine Combined With Cytokine-induced Killer Cells in Patients With Advanced Non-Small-Cell Lung Cancer With Bone Metastases: a Phase I/II Study

Affiliated Hospital to Academy of Military Medical Sciences1 site in 1 country30 target enrollmentFebruary 2016

ConditionsNon-Small-Cell Lung Cancer With Bone Metastases

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Non-Small-Cell Lung Cancer With Bone Metastases
Sponsor: Affiliated Hospital to Academy of Military Medical Sciences
Enrollment: 30
Locations: 1
Primary Endpoint: objective response rate (CR+PR) as measured by RECIST criteria
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this Phase I/II study is to evaluate the safety and efficacy of dendritic cells(DC) vaccine combined with cytokine-induced killer (CIK) cells in patients with Advanced Non-Small-Cell Lung Cancer with bone metastases. Experimental DC was transfected Ad5 vector coding mRNAs including suppressor of cytokine signaling (SOCS) 1, MUC1 and Survivin,are used for DC-based immunotherapy. Based on the results of our previously preclinical study with DC vaccine combined with CIK cells, the investigators plan to perform the clinical trial.

Registry

clinicaltrials.gov

Start Date

February 2016

End Date

February 2018

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Affiliated Hospital to Academy of Military Medical Sciences

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histopathologically confirmed diagnosis of non-small cell lung cancer
•Age \>18 years at time of consent
•Received standardized treatment of Non-Small-Cell Lung Cancer with bone metastases
•KPS (Karnofsky performance scale) \>60
•Patient's written informed consent
•No severe viral or bacterial infections
•Predicted survival \>3 months