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Clinical Trials/NCT02688673
NCT02688673
Unknown
Phase 1

Safety and Therapeutic Efficacy of DC Vaccine Combined With Cytokine-induced Killer Cells in Patients With Extensive-Stage Small- Cell Lung Cancer: a Phase I/II Study

Affiliated Hospital to Academy of Military Medical Sciences0 sites30 target enrollmentAugust 2014
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ConditionsSmall- Cell Lung Cancer

Overview

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

Overview

Brief Summary

The aim of this study is to evaluate the safety and efficacy of dendritic cells (DC) combined with cytokine-induced killer (CIK) cells treatment patients with Extensive-Stage Small-Cell Lung Cancer. Experimental adopted recombinant adenovirus-code MUC1 and Survivin transfected DC, which are used for DC-based immunotherapy. Based on the results of our previously preclinical research with DC combined with CIK cells, the investigators plan to perform the clinical trial.

Registry
clinicaltrials.gov
Start Date
August 2014
End Date
November 2016
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 Small- Cell Lung Cancer
  • •Age \>18 years at time of consent
  • •Received standardized treatment of Small-Cell Lung Cancer
  • •Interval between the last standardized treatment and DC/CIK treatment ≥ 4weeks
  • •KPS (Karnofsky performance scale) \>60
  • •Patient's written informed consent
  • •No severe viral or bacterial infections
  • •Predicted survival \>3 months

Exclusion Criteria

  • •Clinically relevant diseases or infections (HBV, HCV, HIV)
  • •Females who are pregnant or nursing
  • •Immunosuppressant treatment
  • •Currently participating in another clinical trial
  • •Unfit for participating in this clinical trial in investigators' opinions

Outcomes

Primary Outcomes

objective rate response (CR+PR) as measured by RECIST criteria

Time Frame: 4 weeks after DC/CIK treatment]

Secondary Outcomes

  • number of participants with adverse events(3 days within DC/CIK treatment)

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