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This study has been withdrawn prior to enrollment.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
  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:


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 ]

Enrollment: 0
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
Guangzhou, Guangdong, China, 510060
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 5, 2013
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

ClinicalTrials.gov processed this record on April 16, 2014