UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase I study of combination therapy with WT1 peptide-pulsed dendritic cells and gemcitabine for advanced pancreatic and biliary tumors
Title of the study (Brief title)	Combination therapy with WT1 peptide-pulsed dendritic cells and gemcitabine
Region	Japan

Condition
Condition	pancreatic and biliary tumors
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	The aim of the study is to investigate safety and adverse events about combination therapy with WT1 peptide-pulsed dendritic cells and gemcitabine for advanced pancreatic and biliary tumors. Safety: maximum tolerated dose, dose-limiting toxicity, profiles of adverse events.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase I

Assessment
Primary outcomes	Toxicities and adverse events are defined by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale.
Key secondary outcomes	1. Clinical response rate Disease control rate Clinical benefit response 2. QOL outcomes 3. Immune responses to WT1

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Vaccine
Interventions/Control_1	Administration of Gemcitabine Gemcitabine (1000mg/m2 ) is administered via intravenous injection over 30min on day 1, 8, 15 of a 28-day cycle twice. Dendritic cell pulsed WT1 peptide vaccination The patient is intradermally injected with WT1 peptide (HLA-A*2402-restricted, 9-mer modified peptide (p235-243: CYTWNQMN) , HLA-A*02401-restricted peptide (p126-134: RMFPNAPYL), 16-mer WT1 helper peptide (p332-347: KRYFKLSHLQMHSRKH) pulsed dendritic cells over 1 hour after administration of gemsitabine. WT1 peptide pulsed dendritic cells are performed every two weeks four times. Safety and efficacy are evaluated 7-14 days after fourth WT1 vaccination.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Diagnosed as pancreatic or biliary cancer. 2. Informed about hisdiagnosis 3. 1) First-line treatment for inoperable patients. Stage IVa, IVb 2) Relapse after operation Initial chemotherapy Two months after last chemotherapy 4. HLA-A*2402, 0201, 0206, DRB1*0405, DRB1*0803, DRB1*1502, DRB1*1501, DPB1*0901, or DPB1*0501 positive 5. Having evaluable disease by RECIST criteria 6. No chemotherapy/radiation/BRM has been performed. 7. Karnofsky Performance Status (KPS) over 50 8. Survival period is expected more than 3 months 9. Meet the following criteria for organ functions 1) WBC more than 4,000/microliter and less than 12,000, Neutrophil more than 2,000/microliter, Platelet more than 100,000/microliter, Hemoglobin more than 9.5 g/dl 2) Serum creatinine within normal limitation 3) Serum bilirubin less than1.5 folds of the upper normal limit 4) Serum AST/ALT less than 2.5 folds of the upper normal limit 5) Serum Albumin more than 3.0g/dl 10. Patients can tolerate blood component collection (apheresis) to collect peripheral blood mononuclear cells. 11. Pleural effusion, ascites and pericardial effusion are not detected. 12. Informed consent has been obtained.
Key exclusion criteria	1. There is deep-seated active infection. 2. There are severe complications including malignant hypertension, cardiac failure, liver cirrhosis, severe DM, severe lung disease, active interstitial pneumonitis. 3. Patients who have complications are considered in appropriate for the trial. 4. Dependent on total parenteral nutrition (TPN). 5. There are other malignancies. 6. There are hematopoietic stem cell disorders such as myelodisplastic syndrome (MDS) and myeloproliferative disorders (MDP). 7. Pregnant or lactating woman. 8. Past history of severe drug allergy. 9. There is severe psychiatric disease. 10. Responsible doctor's judged the patient inappropriate for the trial.
Target sample size	35

Research contact person
Name of lead principal investigator	Ohkusa Toshifumi
Organization	Jikei University School of Medicine
Division name	Division of Gastroenterology and Hepatology, Department of Internal Medicine
Address	163-1 Kashiwa-shita, Kashiwa, Chiba 277-8564 Japan
TEL	0471-64-1111
Email	ohkusa@jikei.ac.jp

Public contact
Name of contact person	Koido Shigeo
Organization	Jikei University School of Medicine
Division name	Division of Gastroenterology and Hepatology, Department of Internal Medicine
Address	163-1 Kashiwa-shita, Kashiwa, Chiba 277-8567 Japan
TEL	+81-4-7164-1111
Homepage URL
Email	shigeo_koido@jikei.ac.jp

Sponsor
Institute	Department of Internal medicine, Division of Gastroenterology and Hepatology, Kashiwa Hospital, Jikei University School of Medicine
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology etc
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2010 Year 08 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 08 Month 01 Day
Anticipated trial start date	2010 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 08 Month 18 Day
Last modified on	2018 Year 04 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004742