Preliminary clinical results of autologous dendritic cell treatment add on immune modulation with cyclophosphamide in patients with non-small cell lung cancer who completed surgical resection and adjuvant therapy

Not Applicable

Suspended

• Conditions: Neoplasms

• Registration Number: KCT0002969
• Lead Sponsor: Dongnam Institute of Radiological & Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

? Men or women aged 20 years or older
? Patients with a histologically confirmed diagnosis of non-small cell lung cancer (AJCC TMN stage ?A–?A) who completed at least one round of postoperative adjuvant therapy
*adjuvant therapy (chemotherapy: cisplatin/vinorelbine, radiotherapy)
? Patients with an autologous (frozen) tumor tissue sample for non-small cell lung cancer
? Patients with an ECOG score of 0–2 for performance status
? Patients satisfying the following conditions:
- hematologic function: WBC count =4,000/µL, ANC =1,500/µL
- platelet count =100,000/µL, hemoglobin =10 mg/dL
- hepatic function: bilirubin =1.5-fold the normal values, ALT and AST =2.5-fold the normal values
- renal function: creatinine =1.5 mg/dL
? Among fertile patients, individuals consenting to the use of appropriate contraception
? Among female patients who may be pregnant, patients with a negative result in urine HCG tests 7 days before registration
? Individuals who sign the consent form and are able to consent to the study and follow-up procedures

Exclusion Criteria

? Patients who underwent other anticancer therapies excluding radiotherapy, but including immunotherapy or non-cisplatin/vinorelbine chemotherapy, before participating in the trial
? HIV-positive patients
? Patients for whom the planned dose of the test drug cannot be prepared because of the difficulty in obtaining a sufficient amount of autologous tumor tissue
? Patients with findings of autoimmune or inflammatory disease
? Patients with severe heart disease or internal disease
? Patients with central nervous system or psychiatric abnormalities
? Patients with findings of another malignant tumor
? Patients with an ongoing systemic disease (active infection, uncontrolled hypertension, unstable angina, congestive heart failure, liver disease, kidney disease, metabolic disease)
? Pregnant or breastfeeding women
? Patients who have received another test drug less than 4 weeks before the start of treatment with the current test drug
? Patients who have undergone other immunotherapy (excluding G-CSF)
? Patients who have received treatment for tuberculosis within the last year
? Patients who have been judged to be unsuitable as a clinical trial participant by another researcher

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety(Adverse event and concomitant medication)

Secondary Outcome Measures

Name	Time	Method
Examine the immune response;analyze survival (disease-free survival, overall survival)