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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004063
Receipt No. R000004742
Scientific Title A phase I study of combination therapy with WT1 peptide-pulsed dendritic cells and gemcitabine for advanced pancreatic and biliary tumors
Date of disclosure of the study information 2010/08/18
Last modified on 2018/04/26

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Basic information
Public title A phase I study of combination therapy with WT1 peptide-pulsed dendritic cells and gemcitabine for advanced pancreatic and biliary tumors
Acronym Combination therapy with WT1 peptide-pulsed dendritic cells and gemcitabine
Scientific Title A phase I study of combination therapy with WT1 peptide-pulsed dendritic cells and gemcitabine for advanced pancreatic and biliary tumors
Scientific Title:Acronym 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
1st name
Middle name
Last name Ohkusa Toshifumi
Organization Jikei University School of Medicine
Division name Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
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
1st name
Middle name
Last name Koido Shigeo
Organization Jikei University School of Medicine
Division name Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2010 Year 08 Month 01 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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