Randomized phase II study with or without adjuvant immunotherapy of alpha-GalCer-pulsed dendritic cells in the patients with completely resected stage II-IIIA non-small cell lung cancer

Phase 2

• Conditions: Patients with completely resected stage II or IIIA non-small cell lung cancer followed by adjuvant c

• Registration Number: JPRN-jRCTc040190130
• Lead Sponsor: Saka Hideo

Brief Summary

Although it was suggested that the safety of intravenous administration of GalCer pulsed dendritic cells aiming at activation of NKT cells in the body as immunotherapy using NKT cells is high, "No recurrence in the NKT cell therapy group and the standard treatment group" The null hypothesis that "survival times are equal" could not be denied.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-18
• Study Completion: 2020-06-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

1) Patients for whom non-small cell lung cancer is confirmed histologically
2) Patients underwent at least lung lobectomy including elective or non-elective dissection of hilar or mediastinal lymph node
3) Complete resection is judged (Complete resection is defined to be the situation that tumor is completely removed grossly at the time of operation and tumor cells are not noted pathologically on the resection line.)
4) The pathological stage is IIA, IIB, IIIA.
5) At the time of enrollment, patients should be at least 20 years old and younger than 75 years old.
6) no recurrence at the time of enrollment
7) PS (ECOG; Eastern Cooperative Oncology Group) is 0-1.
8) Trial treatment can be started within 4 to 16 weeks after 3-4 cycles of adjuvant chemotherapy with cisplatin and vinorelbine.
9) Functions of the bone marrow, liver, kidney, and lung etc are maintained, satisfying the following conditions. (The following data should be the ones within 2 weeks before enrollment. The same day of the week 2 weeks before enrollment can be included.)
*Neutrophil count >=3,000/mm3
*Platelet count >=75,000/mm3
*Hemoglobin concentration>=9 g/dL
*Serum creatinine <=1.5 mg/dL
*Total bilirubin <=2.0 mg/dL
*AST/ALT <=2.0 X ULN of normal values in each institution
*SpO2 >=93%
10) NKT cells are detected at least 10 cells in 1 ml of peripheral blood.
11) After the details of the trial are explained sufficiently before enrollment in this trial, written consent by patients themselves should be obtained.

Exclusion Criteria

1) Serious concomitant disease including severe infectious disease or malnutrition.
2) Postoperative pleural effusion or ascites or cardiac effusion which need to be controlled.
3) The patient who have simultaneous malignancy or who have metachronous malignancy within 5 years-disease free interval.
4) Concurrent corticosteroid therapy
5)Autoimmune disease
6) History of hepatitis
7) Positive response to HIV, hepatitis C virus or human T cell lymphotrophic virus antibodies or those with HBs antigen.
8) Severe cardiac disease(NYHA class III or IV) or severe pulmonary disease (greater than Hugh-Jones Classification III)
9) History of hyper-reactivity to albmin
10) Pregnancy or lactation
11) Contraindication to apheresis (angina, greater than atrioventricular block 2 degree, WPW syndrome, complete left bundle branch block, systolic blood pressure with 90 Torr or greater than 170 Torr)
12) The patients have been judged to be inappropriate to participate in this study by principal investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
disease free survival at 2 years

Secondary Outcome Measures

Name	Time	Method
KT-specific immune response, safety, overall survival