UMIN ID: UMIN000001295
Registered date:04/08/2008
Phase I trial of CHP-HER2-pulsed dendritic cell vaccine for advanced breast and non-small cell lung cancer
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | breast cancer, non-small cell lung cancer |
| Date of first enrollment | 2006/02/01 |
| Target sample size | 9 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | subcutaneous injection of CHP-HER2-pulsed dendritic cells each cell dose, 0.3x10E7, 1x10E7, 3x10E7 four doses every two weeks three subjects for each cell dose, dose-escalating study |
Outcome(s)
| Primary Outcome | adverse effect profiles, including events, frequency and grades. |
|---|---|
| Secondary Outcome | HER2-specific immune responses anti-tumor effects |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 75years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Pregnancy, contra-ceptive during trial entry. Milking. Serious bleeding tendency. Risk of thrombosis. Acitive infection, HIV, HCV and HBV-positives. Serious pleural effusion, ascites and pericardial effusion. Probable alternative drug treatment during the trial. |
Related Information
| Primary Sponsor | Hokkaido University Hospital, Kyushu University Hospital at Beppu |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Cancer Translational Research, Ministry of Education, Culture, Sports, Science and Technology, Japan |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Masaki Miyamoto1), Fumiaki Tanaka2) |
| Address | Japan |
| Telephone | |
| m-miyamo@med.hokudai.ac.jp | |
| Affiliation | Hokkaido University Hospital1), Kyushu University Beppu Medical Center2) Department of Surgery1,2) |
| scientific contact | |
| Name | Takashi Nishimura, Satoshi Kondo, Masaki Mori |
| Address | Kita-15-Jo, Nishi-7, Kita-ku, Sapporo, Hokkaido, 3-1-1, Tshurumihara, Tsurumi, Beppu, Oita, Japan Japan |
| Telephone | |
| Affiliation | Hokkaido University, Institute for Genetic Medicine1), Hospital1Hokkaido University Hospital2), Kyushu University Hospital at Beppu3) Division of Immunoregulation1), Department of Surgery2,3) |