Head and neck squamous cell carcinoma clinical stage4
Conditions
Interventions
DC or AlphaGalCer pulsed DC
Sponsors
Toyoyuki Hanazawa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Head and neck squamous cell carcinoma clinical stage4 after the standard therapy (operation, radiotherapy and chemotherapy), and it's within 8 weeks from the complete response judgment. we assume that it's registered within 4 months more than the previous treatment. 2.20 to 80 years old 3.Performance Status in ECOG is less than 2 4. The case which satisfies the following data WBC more than 3,000 per mL Plt more than 75,000 per mL Cre less than1.5mg per dL Tbil less than 1.5mg per dL SpO2 (room air) more than 93 AST (GOT)ALT (GPT) less than 2.5 times of standard value 5.Obtained Informed consent
Exclusion criteria
Exclusion criteria: 1.patient with hepatitis or with the past 2.patient withpositive in HBs antigen, HCV antibody, HIV antibody or HTLV-1 antibody 3.patient withtaking or being injected corticosteroid 4.the female with a possibility of the pregnancy or the female of the nursing period 5.patient with autoimmuno diseases 6.patient with infections which presented leukocyte increase beyond more than10,000/u or fever(38) or needed treatment within 2 weeks 7.patient with diabetes of badcontrol 8.patient with lung diseases beyond serious state (MRC The short breath scale more than grade 2 9.patient with serious heart diseases (more than NYHA class III) 10.patient with double or multiple cancer 11.the case by which a doctor and a qualified standard judgment commissioner judged participation in this clinical study to be unsuitable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| relapse-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| The ratio of 2 years overall survival and disease-free survival Immuno response of blood NKT cell Adverse event and its severity | — |
Countries
Japan
Contacts
Public ContactMori Shigemasa
Chiba University Hospital
Outcome results
None listed