The double-blind, randomised controlled phase II study of the adjuvant therapy using alpha-galactosylceramide pulsed antigen presenting cells for patients with head and neck mucosal melanoma followed by standard therapy.
Phase 2
- Conditions
- Head and neck squamous cell carcinoma
- Registration Number
- JPRN-UMIN000009607
- Lead Sponsor
- Chiba University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 66
Inclusion Criteria
Not provided
Exclusion Criteria
Past histry of hepatitis, a positive response for HBs antigen/HCT antibody/HIV antibody/HTL-V1 antibody, recieived concurrent corticosteroid therapy, pregnancy or lactation, antoimmune disease, infection, uncontrolled diabetes mellitus, pulmonary fibrosis, serious cardiac disease, double cancer, judgement of physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Recurrence-free survival
- Secondary Outcome Measures
Name Time Method Two-year recurrence-free survival Two-year overall survival Evaluation of NKT cell specific immune response Safety profile