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.

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. - Chiba NKT therapy for HNSCC

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009607

Enrollment

Registered

2013-04-01

Start date

2013-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and neck squamous cell carcinoma

Interventions

The injections of 100 million of alpha-GalCer pulsed APCs on day 7 and 10 into nasal submucosa. The injections of 100 million of untreated APCs on day 7 and 14 into nasal submucosa.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Stage IV HNSCC; Complete responce (CR) after first standard therapy; Within 8 weeks after the assessment of CR; Within 4 months after previous treatment; pathological diagnosis of squamous cell carcinoma; Performance status is 0 - 2; Normal bone marrow, liver and renal functions; Written informed concent.

Exclusion criteria

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

Design outcomes

Secondary

Measure	Time frame
Two-year recurrence-free survival Two-year overall survival Evaluation of NKT cell specific immune response Safety profile	—

Primary

Measure	Time frame
Recurrence-free survival	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026