NCT02688673

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2014

Typical duration for phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 23, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

February 23, 2016

Status Verified

October 1, 2015

Enrollment Period

2 years

First QC Date

February 18, 2016

Last Update Submit

February 18, 2016

Conditions

Small- Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

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

    4 weeks after DC/CIK treatment]

Secondary Outcomes (1)

  • number of participants with adverse events

    3 days within DC/CIK treatment

Interventions

adenovirus-transfected autologous DC vaccine plus CIK cellsBIOLOGICAL

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2016

First Posted

February 23, 2016

Study Start

August 1, 2014

Primary Completion

August 1, 2016

Study Completion

November 1, 2016

Last Updated

February 23, 2016

Record last verified: 2015-10