UMIN ID: UMIN000001184
Registered date:12/06/2008
Clinical study of alpha-GalactosylCeramide-pulsed dendritic cells in patients with operable primary lung cancer.
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | primary lung cancer (operable case) |
| Date of first enrollment | 2007/11/01 |
| Target sample size | 20 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | 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 DCs are performed at 1, 2, 7 and 8 weeks after the re-entry. In control group, intra-venous injection of alpha-GalactosylCeramide pulsed DCs is not performed before and after operation. |
Outcome(s)
| Primary Outcome | Immunological response |
|---|---|
| Secondary Outcome | Safety, Clinical response |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 80years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude 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. |
Related Information
| Primary Sponsor | Department of Thoracic Surgery, Graduate School of Medicine, Chiba University |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Grant-in-Aid for Scientific Research |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | 1-8-1 Inohana, Chuo-ku, Chiba, Japan Japan |
| Telephone | 043-222-7171 |
| Affiliation | Graduate School of Medicine, Chiba University Department of Thoracic Surgery |
| scientific contact | |
| Name | Ichiro Yoshino |
| Address | 1-8-1 Inohana, Chuo-ku, Chiba, Japan Japan |
| Telephone | |
| Affiliation | Graduate School of Medicine, Chiba University Department of Thoracic Surgery |