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Preconditioning Chemotherapy Combination With Cytokine Induced Killer Cell (CIK) Immunotherapy

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ClinicalTrials.gov Identifier: NCT01902875
Recruitment Status : Unknown
Verified July 2013 by Longbang Chen, Jinling Hospital, China.
Recruitment status was:  Recruiting
First Posted : July 18, 2013
Last Update Posted : July 18, 2013
Sponsor:
Information provided by (Responsible Party):
Longbang Chen, Jinling Hospital, China

Brief Summary:
This clinical Trial is proposed to explore whether preconditioning chemotherapy of Paclitaxel+cisplatin(TP)regimen combined with autologous adoptive CIK cell immunotherapy could benefit NSCLC patients with a better clinical outcome.

Condition or disease Intervention/treatment
Non Small Cell Lung Cancer Drug: Paclitaxel + Cisplatin Biological: CIK cell therapy

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Preconditioning Chemotherapy Combined With Cytokine Induced Killer Cell Immunotherapy in Advanced Non Small Cell Lung Cancer
Study Start Date : June 2013
Estimated Primary Completion Date : December 2014

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
TP regimen + CIK group
This group are treated with Preconditioning Chemotherapy (Paclitaxel + Cisplatin) Combined with Cytokine Induced Killer Cell Immunotherapy (CIK cell therapy).
Drug: Paclitaxel + Cisplatin
Paclitaxel 135mg/m2, intravenous drip, D1; Cisplatin 75 mg/m2, intravenous drip, D1; Repeat for 4 weeks interval.
Other Name: TP

Biological: CIK cell therapy
Peripheral blood mononuclear cell are separated before chemotherapy, and before each CIK cell transfusion. CIK cells are transfused on D7, D14, D21(with simultaneous transfusion of IL-2 2 million units).
Other Name: CIK

TP regimen group
This group are treated with Chemotherapy (Paclitaxel + Cisplatin) only.
Drug: Paclitaxel + Cisplatin
Paclitaxel 135mg/m2, intravenous drip, D1; Cisplatin 75 mg/m2, intravenous drip, D1; Repeat for 4 weeks interval.
Other Name: TP




Primary Outcome Measures :
  1. Disease Control Rate(DCR) and Disease Progression-Free Survival(PFS) [ Time Frame: 8 weeks ]
    Use CT and MRI for scalable lesion to evaluate the efficacy of preconditioning chemotherapy of TP regimen (PTX+DDP) combined with autologous adoptive CIK cell immunotherapy in NSCLC.


Secondary Outcome Measures :
  1. safety and tolerance of patient [ Time Frame: 20 weeks ]
    Assess symptoms, physical examinations and adjuvant exams (such as complete blood count(CBC), blood biochemistry, ECG, chest CT, abdominal ultrasound) to evaluate the safety of the treatment.



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Primary non small cell lung cancer patients with pathology diagnosis.
Criteria

Inclusion Criteria:

  1. Primary non small cell lung cancer patients with pathology diagnosis with clinical TNM Classification of Malignant Tumours (TNM) stage (IIIa~IV) can not accept operation or unwilling to operation;
  2. 40~70 year old, Eastern Cooperative Oncology Group (ECOG) score ≤ 2 points, estimate survival > 3 months;
  3. Blood White Blood Cell(WBC)≥ 4×109/L, Hb ≥ 100g/L, Platelet Count(PLT)≥ 80×109/L; Alanine aminotransferase(ALT) and aspartate aminotransferase(AST)≤ 2 times of normal upper value; Serum Cr ≤ 2 normal upper value;
  4. With more than one scalable lesions;
  5. Without any other malignant disease;
  6. Patients Voluntary attempt, and informed consent.

Exclusion Criteria:

  1. Hypersusceptible to paclitaxel, cisplatin, CIK cells and IL-2;
  2. With no scalable lesions;
  3. Pregnant or lactating women;
  4. Uncontrolled brain metastasis with symptoms or with psychal problems can not describe subjective symptoms;
  5. With serious visceral organs failure;
  6. Patients with the conditions affect the administration, absorb, distribution, metabolism and excretion of the drugs;
  7. History of cardiovascular disease, including congestive heart failure, unstable angina patients, myocardial infarction; Cachexia; or other deadly diseases;
  8. Serious uncontrollable infection;
  9. At present Is receiving other cancer treatment (such as chemotherapy, radiation therapy, chemotherapy, immunosuppressants and thrombosis, targeted agents); Now or recently will join another experimental clinical study;
  10. Other situations that the researchers considered unsuitable for this study (such as mental illness, drug abuse, etc.).

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): NCT01902875


Contacts
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Contact: Guichun Huang, M.D. huangguichun@nju.edu.cn

Locations
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China, Jiangsu
Nanjing General Hospital of Nanjing Military Command(Jinling Hospital) Recruiting
Nanjing, Jiangsu, China, 210002
Contact: Longbang Chen, M.D.       dr.chenlb@nju.edu.cn   
Principal Investigator: Longbang Chen, M.D.         
Sponsors and Collaborators
Jinling Hospital, China

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Responsible Party: Longbang Chen, Dean of Medical Oncology Department, Jinling Hospital, China
ClinicalTrials.gov Identifier: NCT01902875     History of Changes
Other Study ID Numbers: NJ0001
First Posted: July 18, 2013    Key Record Dates
Last Update Posted: July 18, 2013
Last Verified: July 2013

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