Pancreatic cancer refractory or intolerable to standard therapy
Conditions
Interventions
[Course 1 (DLT evaluation period)] OCV-105 3.0mg/ml will be administered on day1, 8, 15, and 22 by subcutaneous injection to the axilla or inguinal region. [On and after Course 2] OCV-105 3.0mg/ml
s condition meets discontinuance criteria.
Sponsors
OncoTherapy Science, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria. (1)Invasive pancreatic ductal carcinoma histologically or cytologically confirmed as adenocarcinoma or squamous cell carcinoma. (2)Refractory or intolerable to standard therapy. -Patient must have treated by Gemcitabine at least one time. -It doesn't matter weather patient had treated by another antitumor drug. -Recurrent case is: Recurrence during adjuvant therapy (Gemcitabine) or recurrence within 28 days from the end of adjuvant therapy (treated for more than 3months [12 weeks]). Recurrence after the adjuvant therapy (Gemcitabine) was completed, and turned refractory or intolerable to Gemcitabine. (3)Patients must be >=20 years old and <=80 years old at the time of consent. (4)Karnofsky Performance Status must be >=80. (5)Patients must have Human Leukocyte Antigen (HLA)-A*24:02. (6)Life Expectancy must be >=3 months. (7)The following criteria must be satisfied in laboratory tests conducted within 21 days before enrollment. And G-CSF, Erythropoetin, Blood products and transfusion must be untried within 21days before enrollment. -White blood cell count >=3,000 /mm3 ,<=12,000/mm3 -Neutrophil count >=2,000 /mm3 -Hemoglobin >= 9.0 g/dL -Platelet count >=100,000 /mm3 -Total bilirubin <=2.0 mg/dL(to be permitted <=3.0 mg/dL in patients treated by biliary drainage for obstructive jaundice) -AST <=150 IU/L -ALT <=150 IU/L -Serum Creatinine <=1.5 mg/dL (8)The period from the end of previous treatment to the beginning of this trial must be satisfied following criteria. -antitumor drug : >=2weeks -radiotherapy : >=4weweks -laparotomy : >=2weeks -systemic treatment of corticosteroid : >=2weeks (9)Patients who can accept to be hospitalized for the period provided by protocol. (10)Patient must have signed the consent form.
Exclusion criteria
Exclusion criteria: Exclusion criteria. (1)Prior treatment of peptide derived from KIF20A, or peptide which is designed for antitumor effect. (2)Active double cancer (include asynchronous double cancer with disease-free duration <=1 year) except carcinoma in situ or intramucosal cancer. (3)Pancreatic cancer infiltrated into digestive tract with serious concern of bleeding. (4)Interstitial pneumonia or pulmonary fibrosis. (5)Cerebral metastasis or being suspected. (6)Pleural effusion, ascites fluid, or pericardial fluid in need of drainage. (7)Uncontrolled heart disease, pulmonary disease, kidney disease, or liver disease. (8)Another uncontrolled complication. (9)Patients who require systemic administration of the following agents during the study treatment period. 1.Corticosteroid 2.Immunosuppresant, Immunostimulant 3.G-CSF 4.Erythropoietin (10)Current participation in other clinical trials. (11)Patient who receive treatment of drug which is not on sale in Japan (Investigational drug or private import drug) within 2 months before enrollment. (12)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 (during the study period and until 180 days after the last administration day for male, or until 120 days after the last administration day for female.). (13)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 adverse event and Dose-Limiting Toxicity (DLT). | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumor regression effect with RECIST 1.1. Transition of Laboratory evidence and Vital signs. | — |
Countries
Japan
Outcome results
None listed