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

NCT01902875 | Unknown DMC

• 1 other identifier: NJ0001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Disease Control Rate(DCR) and Disease Progression-Free Survival(PFS)

  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.

  8 weeks

Secondary Outcomes (1)

• safety and tolerance of patient

  20 weeks

Study Arms (2)

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; Biological: CIK cell therapy

TP regimen group

This group are treated with Chemotherapy （Paclitaxel + Cisplatin） only.

Drug: Paclitaxel + Cisplatin

Interventions

Paclitaxel + Cisplatin DRUG

Paclitaxel 135mg/m2, intravenous drip, D1; Cisplatin 75 mg/m2, intravenous drip, D1; Repeat for 4 weeks interval.

Also known as: TP

TP regimen + CIK group; TP regimen group

CIK cell therapy BIOLOGICAL

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).

Also known as: CIK

TP regimen + CIK group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Primary non small cell lung cancer patients with pathology diagnosis.

You may qualify if:

• 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;
• \~70 year old, Eastern Cooperative Oncology Group (ECOG) score ≤ 2 points, estimate survival \> 3 months;
• 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;
• With more than one scalable lesions;
• Without any other malignant disease;
• Patients Voluntary attempt, and informed consent.

You may not qualify if:

• Hypersusceptible to paclitaxel, cisplatin, CIK cells and IL-2;
• With no scalable lesions;
• Pregnant or lactating women;
• Uncontrolled brain metastasis with symptoms or with psychal problems can not describe subjective symptoms;
• With serious visceral organs failure;
• Patients with the conditions affect the administration, absorb, distribution, metabolism and excretion of the drugs;
• History of cardiovascular disease, including congestive heart failure, unstable angina patients, myocardial infarction; Cachexia; or other deadly diseases;
• Serious uncontrollable infection;
• 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;
• Other situations that the researchers considered unsuitable for this study (such as mental illness, drug abuse, etc.).

Sponsors & Collaborators

• Jinling Hospital, China: lead

Study Sites (1)

Nanjing General Hospital of Nanjing Military Command(Jinling Hospital)

Nanjing, Jiangsu, 210002, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

TP protocol

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Guichun Huang, M.D.

CONTACT

huangguichun@nju.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of Medical Oncology Department

Study Record Dates

• First Submitted: July 14, 2013
• First Posted: July 18, 2013
• Study Start: June 1, 2013
• Primary Completion: December 1, 2014
• Last Updated: July 18, 2013

Record last verified: 2013-07

Locations

CN (1)