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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02688686
Recruitment Status : Unknown
Verified February 2016 by Affiliated Hospital to Academy of Military Medical Sciences.
Recruitment status was:  Not yet recruiting
First Posted : February 23, 2016
Last Update Posted : February 23, 2016
Sponsor:
Information provided by (Responsible Party):
Affiliated Hospital to Academy of Military Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Non-Small-Cell Lung Cancer With Bone Metastases Biological: genetically modified dendritic cells + cytokine-induced killer Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2016
Estimated Primary Completion Date : February 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Biological: genetically modified dendritic cells + cytokine-induced killer
    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 Measures :
  1. objective response rate (CR+PR) as measured by RECIST criteria [ Time Frame: one month after DC/CIK treatment ]

Secondary Outcome Measures :
  1. number of participants with adverse events [ Time Frame: 3 days during DC/CIK treatment] ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02688686


Contacts
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Contact: Guo liang ding, master dingguoliang1999@sina.com

Locations
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China, Beijing
Affiliated Hospital to Academy of Military Medical Sciences
Beijing, Beijing, China, 100071
Sponsors and Collaborators
Affiliated Hospital to Academy of Military Medical Sciences
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Responsible Party: Affiliated Hospital to Academy of Military Medical Sciences
ClinicalTrials.gov Identifier: NCT02688686    
Other Study ID Numbers: 307-CTC-DC/CIK-NSCLC-001
First Posted: February 23, 2016    Key Record Dates
Last Update Posted: February 23, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis
Bone Neoplasms
Bone Marrow Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplastic Processes
Pathologic Processes
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases