UMIN ID: UMIN000000910
Registered date:28/11/2007
Phase I Study of Gemcitabine-Combined WT1 Peptide Vaccine Treatment for Patients with Advanced Pancreas or Biliary Duct Cancer
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Advanced pancreatic cancer or biliary duct cancer |
| Date of first enrollment | 2007/11/01 |
| Target sample size | 36 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Gemcitabine is administered on days 1, 8, and 15 and WT1 peptideis injected on days 8 and 22. The treatment is repeated two times. (28 days cycle) |
Outcome(s)
| Primary Outcome | Evaluation of safety and dose-finding study |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1) Active infection excluding hepatitis virus 2) Significant complications which include cardiac dysfunction, renal failure, liver failure, active peptic ulcer, paralytic ileus, uncontrolled diabetes, etc. 3) Moderate ascites or thoracic effusion which required centesis 4) CNS involvement 5) Serious neuropsychological complications 6) Pregnant or feeding female, female who want to have a baby 7) Symptomatic interstitial pneumonitis or fibrosis confirmed by chest X-ray 8) Complicated myelodysplastic syndrome (MDS), myeloproliferative diseases (MPD) or chronic myelocytic leukemia (CML) 9) History of autoimmune disorders 10) Receiving immunosuppresants or steroids 11) Other conditions that physicians deny patient participation |
Related Information
| Primary Sponsor | Department of Clinical Trial Coordination and Developmental Therapeutics National Cancer Center Hospital |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Ministry of Health, Labour and Welfare |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Japan |
| Telephone | 03-3547-5293 |
| Affiliation | National Cancer Center Hospital Support Center for Patients and Families |
| scientific contact | |
| Name | Yuji Heike |
| Address | 5-1-1, Tsukiji, Chuo-ku, Tokyo Japan |
| Telephone | 03-3542-2511 |
| Affiliation | National Cancer Center Hospital Department of Clinical Trial Coordination and Developmental Therapeutics |