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

The phase I/II study of the adjuvant therapy using alpha-galactosylceramide pulsed dendritic cells for patients with advanced high-grade salivary gland tumor followed by standard therpies. - The phase I/II study of the adjuvant therapy using alpha-GalCer pulsed DCs for salivary gland tumor.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000024669

Enrollment

Registered

2016-11-01

Start date

2016-11-01

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

Salivary gland tumor

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) 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. 2) Within 3 months after preceding therapies. 3) 20~80 years old. 4) Performance status is 0 or 1 5) Normal bone marrow, liver and renal functions. 6) Written informed concent.

Exclusion criteria

Exclusion criteria: 1) Past history of hepatitis. 2) A positive response for HBs antigen/HCV antibody/HIV antibody/HTL-V1 antibody. 3) Concurrent corticosteroid therapy. 4) Pregnancy or lactation. 5) Autoimmune disease. 6) Sever infection 7) Uncontrolled DM. 8) Sever pulmonary emphysema or fibrosis. 9) Serious cardiac disease. 10) Double cancer. 11) Hypersensitivity for albumin 12) Judgement of physician.

Design outcomes

Primary

Measure	Time frame
Phase I: Safety profile Phase II: Two-year overall survival	—

Secondary

Measure	Time frame
Evaluation of peripheral iNKT cell specific immune response	—

Countries

Japan

Contacts

Public ContactFumie Ihara

Chiba University Hospital Center of Advanced Medicine

fumiko_ibaaa@yahoo.co.jp043-226-2718

Outcome results

None listed

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