UMIN ID: UMIN000004081
Registered date:21/08/2010
WT1 peptide-based vaccination combined with Gemcitabine for advanced pancreatic and biliary tract cancers
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | advanced pancreatic and biliary tract cancers |
| Date of first enrollment | 2010/07/01 |
| Target sample size | 20 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Administration of Gemcitabine: Gemcitabine(1000mg/m2)is administered via intravenous injection over 30min on day 1, 8, 15 of a 28-day cycle twice. WT1 vaccination: The patient is intradermally injected with 3 mg of the HLA-A*2402-restricted, 9-mer WT1 peptide (CYTWNQMNL) emulsified with Montanide ISA51 adjuvant over 1 hour after administration of gemsitabine. WT1 vaccine is performed every two weeks four times. Safty and efficacy are evaluated 7-14 days after fourth WT1 vaccination. |
Outcome(s)
| Primary Outcome | Toxicities and adverse events are defined by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale. |
|---|---|
| Secondary Outcome | 1. Climical response rate, Disease control rate, Clinical benefit response 2. QOL outcomes 3. Immune responses to WT1 |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 75years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1. There is deep-seated active infection. 2,3. There are severe complications including malignant hypertention, cardiac failure, liver cirrhosis, severe DM, severe lung fibrosis, active interstitial pneumonitis. Patients who have complications that are considered inappropriate for the trial. 4. Dependent on total parenteral nutrition (TPN) 5. There are other malignancies. 6. There are hematopoietic stem cell disorders such as myelodysplastic syndorome (MDS) and myeloproliferative disorders (MPD). 7. Pregnant or lactating woman 8. Past history of severe drug allergy 9. There is severe psychiatric disorder. 10. Responsible doctor's judged the patient inappropriate for the trial. |
Related Information
| Primary Sponsor | Department of Internal medicine, Division of Gastroenterology and Hepatology, Kashiwa Hospital, Jikei University School of Medicine |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Ministry of Education, Culture, Sports, Science and Technology |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Shigeo Koido |
| Address | Japan |
| Telephone | |
| shigeo_koido@jikei.ac.jp | |
| Affiliation | Jikei University School of Medicine Division of Gastroenterology and Hepatology, Department of Internal Medicine |
| scientific contact | |
| Name | Haruo Sugiyama |
| Address | 1-7, Yamada-oka, Suita City, Osaka , Japan Japan |
| Telephone | |
| Affiliation | Osaka University Medical School Department of Clinical Laboratory Science |