- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02688686
Safety and Efficacy of DC-CIK in Patients With Advanced Non-Small-Cell Lung Cancer With Bone Metastases
February 18, 2016 updated by: Affiliated Hospital to Academy of Military Medical Sciences
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
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.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Guo liang ding, master
- Email: dingguoliang1999@sina.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100071
- Affiliated Hospital to Academy of Military Medical Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
objective response rate (CR+PR) as measured by RECIST criteria
Time Frame: one month after DC/CIK treatment
|
one month after DC/CIK treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
number of participants with adverse events
Time Frame: 3 days during DC/CIK treatment]
|
3 days during DC/CIK treatment]
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2016
Primary Completion (Anticipated)
February 1, 2018
Study Registration Dates
First Submitted
February 18, 2016
First Submitted That Met QC Criteria
February 18, 2016
First Posted (Estimate)
February 23, 2016
Study Record Updates
Last Update Posted (Estimate)
February 23, 2016
Last Update Submitted That Met QC Criteria
February 18, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Hematologic Diseases
- Musculoskeletal Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Neoplastic Processes
- Bone Diseases
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Neoplasm Metastasis
- Bone Neoplasms
- Bone Marrow Diseases
Other Study ID Numbers
- 307-CTC-DC/CIK-NSCLC-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Non-Small-Cell Lung Cancer With Bone Metastases
-
Angela Taber MDBayer; The Miriam Hospital; Rhode Island HospitalCompletedNon Small Cell Lung Cancer With Bone MetastatsesUnited States
-
Radiotherapy Oncology Centre "Santa Maria" HospitalPaola Anselmo,MD; Michelina Casale,PhD; Fabio Trippa,MDRecruitingNSCLC | Non Small Cell Lung Cancer | EGF-R Positive Non-Small Cell Lung Cancer | Non Small Cell Lung Cancer Metastatic | NSCLC Stage IV | Oligometastatic Disease | Non-Small Cell Squamous Lung Cancer | Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor | Non-Small Cell Adenocarcinoma and other conditionsItaly
-
Daping Hospital and the Research Institute of Surgery...UnknownNon-small Cell Lung Cancer | Bone Metastasis
-
Sun Yat-sen UniversityNovartisCompletedBone Metastases | Non-small Cell Lung CancerChina
-
Sun Yat-sen UniversityNovartisCompletedNon Small Cell Lung Cancer | Bone Metastases | High NTX LevelChina
-
Angiochem IncTerminatedNon-small Cell Lung Cancer (NSCLC) With Brain MetastasesUnited States, Canada
-
Ruijin HospitalUnknownSpinal Metastases | Non-Small-Cell Lung Cancer MetastaticChina
-
Guangdong Association of Clinical TrialsNot yet recruitingDacomitinib for EGFR Mutated Non-Small Cell Lung Cancer (NSCLC) With Brain Metastases
-
Medolution Ltd.RecruitingBrain Metastases | Non-Small Cell Lung Cancer With EGFR MutationChina
-
BIND TherapeuticsCompletedSquamous Cell Non-small Cell Lung Cancer | KRAS Positive Patients With Non-small Cell Lung CancerUnited States, Russian Federation
Clinical Trials on genetically modified dendritic cells + cytokine-induced killer
-
Guangxi Medical UniversityUnknown
-
Siriraj HospitalMahidol UniversityUnknownCholangiocarcinomaThailand
-
Robert NegrinNational Institutes of Health (NIH)UnknownMultiple Myeloma | Blood and Marrow Transplant (BMT)United States
-
The First People's Hospital of ChangzhouActive, not recruitingUrinary Bladder Neoplasms
-
The First People's Hospital of ChangzhouNot yet recruitingEsophageal Squamous Cell Carcinoma
-
Guangxi Medical UniversityUnknown
-
Yanjuan ZhuUnknown
-
The First People's Hospital of ChangzhouActive, not recruiting
-
The First People's Hospital of ChangzhouActive, not recruiting