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

Non-Small-Cell Lung Cancer With Bone Metastases Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02688686
• Other study ID #: 307-CTC-DC/CIK-NSCLC-001
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: February 18, 2016
• Last updated: February 18, 2016
• Start date: February 2016

Study information

• Verified date: February 2016
• Source: Affiliated Hospital to Academy of Military Medical Sciences
• Contact: Guo liang ding, master
• Email: dingguoliang1999[@]sina.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Bone Neoplasms
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Neoplasm Metastasis
• Non-Small-Cell Lung Cancer With Bone Metastases

Intervention

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.

Locations

Country	Name	City	State
China	Affiliated Hospital to Academy of Military Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital to Academy of Military Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objective response rate (CR+PR) as measured by RECIST criteria		one month after DC/CIK treatment	No
Secondary	number of participants with adverse events		3 days during DC/CIK treatment]	Yes