Study of Chemotherapy Combination With Autologous Cytokine-Induced Killer Cell Immunotherapy to Treat Lung Cancer (CIK)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2013 by Tianjin Medical University Cancer Institute and Hospital
Sponsor:
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier:
NCT01631357
First received: May 27, 2012
Last updated: March 24, 2014
Last verified: February 2013
  Purpose

This randomized, open-label phase II/III study is to evaluate the effects of chemotherapy combination with autologous cytokine-induced killer Cell immunotherapy in patients with stage IIIb-IV squamous non-small-cell lung cancer


Condition Intervention Phase
Lung Cancer
Drug: Arm 1: cytokine-induced killer cell + cisplatin + paclitaxel
Drug: Arm 2: cisplatin + paclitaxel
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Phase II/III Study of Chemotherapy Combination With Autologous Cytokine-Induced Killer Cell Immunotherapy in Stage IIIb-IV Squamous Non-Small-Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Tianjin Medical University Cancer Institute and Hospital:

Primary Outcome Measures:
  • Overall survival [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: April 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Arm 1: We design chemotherapy combination with CIK cell immunotherapy as a experimential arm.
Drug: Arm 1: cytokine-induced killer cell + cisplatin + paclitaxel
TP regimen: intravenous infusions; paclitaxel, 135 mg/m2, day 1; intravenous injection cisplatin, 80 mg/m2, day 1; one cycle every month; up to 6 cycles. CIK cells: intravenous infusions; 5-6 × 109 CIK cells, days 14 and 15; one cycle every month; at least 6 cycles.
Active Comparator: Arm 2
Arm 2: We design chemotherapy alone as a control arm
Drug: Arm 2: cisplatin + paclitaxel
TP regimen: intravenous infusions; paclitaxel, 135 mg/m2, day 1; intravenous injection cisplatin, 80 mg/m2, day 1; one cycle every month; up to 6 cycles.

Detailed Description:
  1. Phase II/III study,
  2. Randomized, open-label study,
  3. evaluated the effects of chemotherapy combination with autologous cytokine-induced killer Cell immunotherapy compared with chemotherapy in patients with stage IIIb-IV squamous non-small-cell lung cancer
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Sex: male or female
  • Age: from 18 to 80 years
  • Histology: squamous non-small-cell lung cancer
  • Clinical stage: from stage IIIb to stage IV
  • Therapy: not received chemotherapy, radiotherapy, or immunotherapy before entry into this study
  • Karnofsky performance status: more than 50%
  • Expected survival: more than 2 months
  • Laboratory tests results 7 days before the start of treatment:

White blood cells: more than 3.0 × 109/L Platelets: more than 100 × 109/L Neutrophils: more than 1.5 × 109/L Hemoglobin: more than 80g/L Serum glutamate pyruvate transaminase: less than 2.5 folds of the upper normal limit (ULN) Serum glutamic-oxal (o) acetic transaminase: less than 2.5 × ULN Serum bilirubin: less than 1.25 × ULN Serum creatinine: less than 1.25 × ULN

  • pregnancy test: the test of women of child-bearing period must be negative 7 days before the start of treatment
  • Contraception: male and female subjects of child-bearing period must adopt a reliable method of contraception before entry into this study until 30 days after stopping this study
  • Informed consent: subject must have the ability to understand and voluntarily sign a written informed consent

Exclusion Criteria:

  • History of neoplasms: other neoplasms
  • Medical history: mental disease, or congestive heart failure, or severe coronary artery disease, or cardiac arrhythmias, or concomitant corticosteroid therapy
  • History of allergies: allergic to the study drugs
  • Metastasis: clinical symptoms of brain metastasis
  • Other clinical trial: the subject received other clinical trial before this study
  • Laboratory tests: the serum test of human immunodeficiency virus, or hepatitis B virus, or hepatitis C virus was positive
  • Woman: pregnant or lactating women
  • Compliance: poor compliance
  • History of neoplasms: other neoplasms
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01631357

Contacts
Contact: Xiubao Ren 86-22-23340123-6322 xinweizhang@yahoo.com

Locations
China, Tianjin
Tianjin Medical University Cancer Institute and Hospital Active, not recruiting
Tianjin, Tianjin, China, 300060
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
Investigators
Study Chair: Xiubao Ren, MD, PhD Tianjin Medical University Cancer Institute and Hospital
  More Information

No publications provided

Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT01631357     History of Changes
Other Study ID Numbers: CIH-RXB-201205001
Study First Received: May 27, 2012
Last Updated: March 24, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Cisplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014