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

This study is currently recruiting participants.
Verified February 2012 by Sun Yat-sen University
Sponsor:
Information provided by (Responsible Party):
Li Zhang, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01533727
First received: February 12, 2012
Last updated: December 20, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Non-small Cell Lung Cancer
 Drug: Autologous CIK Transfusion plus Chemotherapy
Drug: chemotherapy alone
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • the relapse rate [ Time Frame: 30 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 222
Study Start Date: August 2011
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Autologous CIK Transfusion plus Chemotherapy
 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
Active Comparator: Group B
chemotherapy alone
 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;

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. HIV positive
  2. autoimmune disease
  3. immune deficiency disorder
  4. organ transplantation
  5. received high dose glucocorticoid or other immune depressant within 4 weeks
  6. active clinically serious infections (> grade 2 NCI-CTC version 3.0)
  7. life threatening medical condition
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01533727

Locations
China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Li Zhang, MD     86-20-87343458     zhangli6@mail.sysu.edu.cn    
Principal Investigator: Li Zhang, MD            
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Li Zhang, MD Sun Yat-sen University
  More Information

No publications provided

Responsible Party: Li Zhang, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01533727     History of Changes
Other Study ID Numbers: 2010014
Study First Received: February 12, 2012
Last Updated: December 20, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Sun Yat-sen University:
Cytokine-Induced Killer Cell
NSCLC
adjuvant therapy

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013