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Safety and Efficacy of DC-CIK in Patients With Advanced Non-Small-Cell Lung Cancer With Bone Metastases

Primary Purpose

Non-Small-Cell Lung Cancer With Bone Metastases

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
genetically modified dendritic cells + cytokine-induced killer
Sponsored by
Affiliated Hospital to Academy of Military Medical Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small-Cell Lung Cancer With Bone Metastases

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Exclusion Criteria:

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

Sites / Locations

  • Affiliated Hospital to Academy of Military Medical Sciences

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

number of participants with adverse events

Full Information

First Posted
February 18, 2016
Last Updated
February 18, 2016
Sponsor
Affiliated Hospital to Academy of Military Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02688686
Brief Title
Safety and Efficacy of DC-CIK in Patients With Advanced Non-Small-Cell Lung Cancer With Bone Metastases
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
February 2018 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Affiliated Hospital to Academy of Military Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small-Cell Lung Cancer With Bone Metastases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
genetically modified dendritic cells + cytokine-induced killer
Intervention Description
This Phase I/II Study to evaluate clinical efficacy, safety of genetically modified dendritic cells in combination with cytokine-induced killer cell treament in NSCLC with bone metastases.
Primary Outcome Measure Information:
Title
objective response rate (CR+PR) as measured by RECIST criteria
Time Frame
one month after DC/CIK treatment
Secondary Outcome Measure Information:
Title
number of participants with adverse events
Time Frame
3 days during DC/CIK treatment]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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 Exclusion Criteria: Clinically relevant diseases or infections (HBV, HCV, HIV) Females who are pregnant or nursing Immunosuppressant treatment Currently participating in another clinical trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guo liang ding, master
Email
dingguoliang1999@sina.com
Facility Information:
Facility Name
Affiliated Hospital to Academy of Military Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100071
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Safety and Efficacy of DC-CIK in Patients With Advanced Non-Small-Cell Lung Cancer With Bone Metastases

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