Advanced pancreatic cancer or biliary duct cancer
Conditions
Interventions
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)
Sponsors
Department of Clinical Trial Coordination and Developmental Therapeutics National Cancer Center Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with pancreatic cancer or biliary duct cancer, which was histologically confirmed as adenocarcinoma or adenosquamous carcinoma. 2) Patients with locally advanced or recurrent tumor with no indication of curative operation regardless presence or absence of measurable lesion 3) Gemcitabine-naive patients 4) HLA-A0201 or HLA-A2402 genotype 5) Age older than 20 years 6) ECOG PS: 0-2 7) Expected survival of => 2 months 8) Well preserved major organ function WBC: =>3,000/mm3, Neutrophils: =>1,500/mm3, Platelet: =>100K /mm3, Total bilirubin: <=3.0 mg/dL, Albumin: =>3.0 g/dL, ASTand ALT: <=150IU/l, Serum creatinine:<=1.5 mg/dL 10) Available signed informed consent
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of safety and dose-finding study | — |
Countries
Japan
Outcome results
None listed