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 a carbon ion radiotherapy.

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 a carbon ion radiotherapy. - The phase II study using alpha-GalCer pulsed APCs for patients with head and neck mucosal melanoma followed by a carbon ion radiotherapy.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009430

Enrollment

Registered

2012-11-29

Start date

2012-11-29

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 mucosal malignant melanoma

Interventions

The injections of 100 million of alpha-GalCer pulsed APCs on day 7 and 14 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: Head and neck mucosal malignant melanoma patients who completed the carbon ion radiotherapy concomitant with chemotherapy; pathological diagnosis of melanoma; Life-expectancy is more than 6 months; Performance status is 0 or 1; Normal bone marrow, liver and renal functions; Detectable NKT cells in peripheral blood.

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

Primary

Measure	Time frame
Recurrence-free survival	—

Secondary

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

Countries

Japan

Outcome results

None listed

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