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

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ClinicalTrials.gov Identifier: NCT01631357
Recruitment Status : Unknown
Verified February 2013 by Tianjin Medical University Cancer Institute and Hospital.
Recruitment status was:  Not yet recruiting
First Posted : June 29, 2012
Last Update Posted : December 22, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Lung Cancer Drug: Arm 1: cytokine-induced killer cell + cisplatin + paclitaxel Drug: Arm 2: cisplatin + paclitaxel Phase 2 Phase 3

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2016
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Overall survival [ Time Frame: up to 3 years ]

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: up to 3 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT01631357     History of Changes
Other Study ID Numbers: CIH-RXB-201205001
First Posted: June 29, 2012    Key Record Dates
Last Update Posted: December 22, 2015
Last Verified: February 2013

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action