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Clinical study of alpha-GalactosylCeramide-pulsed dendritic cells in patients with operable primary lung cancer.

Clinical study of alpha-GalactosylCeramide-pulsed dendritic cells in patients with operable primary lung cancer. - Clinical study of alpha-GalactosylCeramide-pulsed dendritic cells in patients with operable primary lung cancer.

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001184
Enrollment
20
Registered
2008-06-12
Start date
2007-11-01
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

primary lung cancer (operable case)

Interventions

In patients, intra-venous injection of alpha-GalactosylCeramide pulsed DCs is performed at 1week before operation. Within 3 months after operation he is re-entried, and alpha-GalactosylCeramide pulsed

Sponsors

Department of Thoracic Surgery, Graduate School of Medicine, Chiba University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients between 20 and 80 years of age, with a histologic or cytologic diagnosis of non–small cell lung cancer for which operation is planned. 2. Clinical stage is IIB or IIIA. 3. Performance status of 0, 1, or 2 4. Normal or near normal renal, hepatic, and hematopoietic function 5. NKT cells are detected at least 10 cells in 1 mL of peripheral blood.

Exclusion criteria

Exclusion criteria: 1. Patients who have been treated with surgery or chemotherapy or radiotherapy received for at least 4 weeks before enrollment. 2. Histology is large cell neuroendocrine carcinoma. 3. The exclusion criteria were a positive response to HIV, hepatitis C virus, or human T-cell lymphotrophic virus antibodies; positive for hepatitis B antigen; the presence of active inflammatory disease or active autoimmune disease; a history of hepatitis; pregnancy or lactation; concurrent corticosteroid therapy; and evidence for another active malignant neoplasm. The histologic type, tumor-node-metastasis classification, and the antitumor effect of treatment were classified according to the general rules for clinical and pathologic recording of lung cancer as described by the Japan Lung Cancer Society.

Design outcomes

Primary

MeasureTime frame
Immunological response

Secondary

MeasureTime frame
Safety, Clinical response

Countries

Japan

Outcome results

None listed

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