pancreatic cancer
Conditions
Interventions
(1) Investigational drug DSP-7888 10.5mg will be administered intracutaneously weekly for 8 weeks (2 courses). After 2 courses, DSP-7888 3.5mg will be administered intracutaneously bi-weekly. (2)
Sponsors
Wakayama Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Metastatic pancreatic carcinoma histologically or cytologically confirmed as adenocarcinoma or squamous cell carcinoma (2) No prior chemotherapy and radiotherapy (3) ECOG Performance Status must be 0 or 1. (4) Patients must have following type of Human Leukocyte Antigen class I; HLA-A*24:02, HLA-A*02:01/06 (5) Life Expectancy must be >=3 months. (6) Patients must be >=20 years old and <=79 years old at the time of consent. (7) The following criteria must be satisfied in screening laboratory data. -White blood cell count <=12,000/mm3 -Neutrophil count >=1,500/mm3 -Hemoglobin >= 9.0 g/dL -Platelet count >=10,000mm3 -Total bilirubin <=1.25 times ULN -AST, ALT <=2.5 times ULN -Serum Creatinine <=1.5 mg/dL (8) Patient must have signed the consent form
Exclusion criteria
Exclusion criteria: (1) Interstitial pneumonia or pulmonary fibrosis (2) Comfirmed or suspicious brain metastatis (3) Pleural effusion, ascites fluid, or pericardial fluid in need of drainage. (4) Severe infection or being suspected (5) Positive for serum HBs Ag or HBV-DNA (6) Positive for anti-HCV or anti-HIV ab (7) Patients who require systemic administration of Corticosteroid (8) Prior DSP-7888, other WT1 peptides, or WT1 immunotherapy (9) History of severe allergies to oil products (10) History of hypersensitivity to paclitaxel, albumin, and gemcitabine (11) Active another cancer to define the pprognosis (12) Severe mental disorders (13) Peripheral neuropathy >=CTCAE ver.4.0JCOG Grade 2 (14) Uncontrolled heart disease, pulmonary disease, kidney disease, or liver disease. (15)Myocardial infarction, severe unstable angina pectoris, colonary or peripheral artery bypass, congestive heart failure, cerebrovascular disease, pulmonary embolization, deep vein thrombosis or other severe thromboembolism within 12 months (16) Bleeding tendency or severe coagulation disorder (17) Current participation in other clinical trials. (18) Pregnant females or nursing mothers who can not stop lactation after the recruitment. Patients or partners, who don't attempt to doing contraception during the study period. (19) The subject who was determined by investigator that being not adequate to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of DLT related to investigational drug. | — |
Countries
Japan
Contacts
Public ContactMotoki Miyazawa
Wakayama Medical University Second Department of Surgery
Outcome results
None listed