The phase I/II study of the adjuvant therapy using alpha-galactosylceramide pulsed antigen presenting cells for patients with high-grade salivary grand tumor followed by standard therpies.

The phase I/II study of the adjuvant therapy using alpha-galactosylceramide pulsed antigen presenting cells for patients with high-grade salivary grand tumor followed by standard therpies. - The phase I/II study of the adjuvant therapy using alpha-galactosylceramide pulsed antigen presenting cells for patients with salivary grand tumor.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011509

Enrollment

Registered

2013-08-18

Start date

2013-08-18

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

High-grade salivary grand tumor

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Stage IV salivary grand tumor; pathological diagnosis of mucoepidermoid carcinoma/adenoid cystic carcinoma/salivary duct carcinoma/adenocarcinoma/Carcinoma ex-pleomorphic adenoma; completed the standard therapies; Performance status is 0 or 1; 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

Primary

Measure	Time frame
Safety profile	—

Secondary

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

Countries

Japan

Contacts

Public ContactNaoki KUnii

Chiba University Hospital Center of Advanced Medicine

kunii@chiba-u.jp043-2262718

Outcome results

None listed

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