Study of Chemotherapy Combination With Autologous Cytokine-Induced Killer Cell Immunotherapy to Treat Lung Cancer
Conditions
Lung Cancer
Conditions: official terms
Lung Neoplasms
Study Type
Interventional
Study Phase
Phase 2/Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Intervention
Name: Arm 1: cytokine-induced killer cell + cisplatin + paclitaxel Type: Drug
Name: Arm 2: cisplatin + paclitaxel Type: Drug
Overall Status
Not yet recruiting
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
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 18 Years
Gender: Both
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
Location
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin, China
Status: Active, not recruiting
Start Date
April 2014
Completion Date
December 2015
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Source
Tianjin Medical University Cancer Institute and Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page