CIK Cell Transfusion Plus Chemotherapy as Adjuvant Therapy for Stage IB-IIIA Non-Small Cell Lung Cancer (NSCLC)

This study has been withdrawn prior to enrollment.

(Few patients would like to participate ,since CIK cell transfusion was a new treatment and its efficacy was doubted.)

Sponsor:

Information provided by (Responsible Party):

Li Zhang, Sun Yat-sen University

ClinicalTrials.gov Identifier:

NCT01533727

First received: February 12, 2012

Last updated: December 5, 2013

Last verified: February 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 12, 2012

Last Updated Date

December 5, 2013

Start Date ^ICMJE

August 2011

Estimated Primary Completion Date

December 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

the relapse rate [ Time Frame: 30 months ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01533727 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

CIK Cell Transfusion Plus Chemotherapy as Adjuvant Therapy for Stage IB-IIIA Non-Small Cell Lung Cancer (NSCLC)

Official Title ^ICMJE

A Phase 2,Open-label Study of Autologous Cytokine-Induced Killer Cell Transfusion Plus Chemotherapy as Adjuvant Therapy for Stage IB-IIIA Non-Small Cell Lung Cancer

Brief Summary

Non - small cell lung cancer ( NSCLC ) accounts for more than 80% of lung cancer. The main treatment for early stage patients is surgical resection, but about 30% -70% patients will relapse. Postoperative chemotherapy is the major systemic treatment for surgical resection NSCLC patients. However, data show only 5-10% improvement in overall survival with systemic adjuvant chemotherapy. It is necessary to further improve the survival time of patients with lung cancer. Biological treatment is becoming a new treatment modality for Cancer following with surgery, radiotherapy and chemotherapy, and has been confirmed as an effective adjuvant treatment in comprehensive cancer treatment. Cytokine induced killer cells ( CIK) characterized as fast amplification, strong anti-cancer activity and broad anti-tumor spectrum is most widely used and thought to be the first choice for the new generation of anti-tumor adoptive immunotherapy. This Phase II study is investigating the efficacy of Autologous Cytokine-Induced Killer Cell Transfusion plus Chemotherapy as adjuvant therapy for stage IB-IIIA NSCLC.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Non-small Cell Lung Cancer

Intervention ^ICMJE

Drug: Autologous CIK Transfusion plus Chemotherapy
vinorelbine 25-30mg/m2 d1, d8 q3w; DDP 75mg/m2 d1 q3w; pemetrexed 500mg/m2 d1 q3w; carboplatin AUC 5/6 q3w; CIK infusion D14 q3w
Drug: chemotherapy alone
vinorelbine 25-30mg/m2 d1, d8 q3w; DDP 75mg/m2 d1 q3w; pemetrexed 500mg/m2 d1 q3w; carboplatin AUC 5/6 q3w;

Study Arms

Experimental: Group A
Autologous CIK Transfusion plus Chemotherapy

Intervention: Drug: Autologous CIK Transfusion plus Chemotherapy
Active Comparator: Group B
chemotherapy alone

Intervention: Drug: chemotherapy alone

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Enrollment ^ICMJE

Estimated Completion Date

December 2020

Estimated Primary Completion Date

December 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Stage IB-IIIA post-surgery NSCLC patients with histologically confirmed.
with an Eastern CooperativeOncology Group performance status of 0 or 1,
at least 18 years of age
adequate bone marrow reserve and organ function including calculated creatinine clearance 45 mL/min based on the standard Cockcroft and Gault formula
patients had fully recovered from its acute effects.

Exclusion Criteria:

HIV positive
autoimmune disease
immune deficiency disorder
organ transplantation
received high dose glucocorticoid or other immune depressant within 4 weeks
active clinically serious infections (> grade 2 NCI-CTC version 3.0)
life threatening medical condition

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 70 Years (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

China

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01533727

Other Study ID Numbers ^ICMJE

2010014

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Li Zhang, Sun Yat-sen University

Study Sponsor ^ICMJE

Sun Yat-sen University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Li Zhang, MD

Sun Yat-sen University

PRS Account

Sun Yat-sen University

Verification Date

February 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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