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

NCT01533727 | Withdrawn Phase 2 DMC

• 1 other identifier: 2010014
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer

Keywords

Cytokine-Induced Killer Cell; NSCLC; adjuvant therapy

Outcome Measures

Primary Outcomes (1)

• the relapse rate

  30 months

Study Arms (2)

Group A

EXPERIMENTAL

Autologous CIK Transfusion plus Chemotherapy

Drug: Autologous CIK Transfusion plus Chemotherapy

Group B

ACTIVE COMPARATOR

chemotherapy alone

Drug: chemotherapy alone

Interventions

Autologous CIK Transfusion plus Chemotherapy DRUG

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

Group A

chemotherapy alone DRUG

vinorelbine 25-30mg/m2 d1, d8 q3w; DDP 75mg/m2 d1 q3w; pemetrexed 500mg/m2 d1 q3w; carboplatin AUC 5/6 q3w;

Group B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Li Zhang, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 12, 2012
• First Posted: February 15, 2012
• Study Start: August 1, 2011
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2020
• Last Updated: December 9, 2013

Record last verified: 2012-02

Locations

CN (1)