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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004081
Receipt No. R000004915
Scientific Title WT1 peptide-based vaccination combined with Gemcitabine for advanced pancreatic and biliary tract cancers
Date of disclosure of the study information 2010/08/21
Last modified on 2013/02/22

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Basic information
Public title WT1 peptide-based vaccination combined with Gemcitabine for advanced pancreatic and biliary tract cancers
Acronym WT1 peptide-based vaccination combined with Gemcitabine for advanced pancreatic and biliary tract cancers
Scientific Title WT1 peptide-based vaccination combined with Gemcitabine for advanced pancreatic and biliary tract cancers
Scientific Title:Acronym WT1 peptide-based vaccination combined with Gemcitabine for advanced pancreatic and biliary tract cancers
Region
Japan

Condition
Condition advanced pancreatic and biliary tract cancers
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
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 and gemcitabine for advanced pancreatic and biliary tract cancers. 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. Climical 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. WT1 vaccination: The patient is intradermally injected with 3 mg of the HLA-A*2402-restricted, 9-mer WT1 peptide (CYTWNQMNL) emulsified with Montanide ISA51 adjuvant over 1 hour after administration of gemsitabine. WT1 vaccine is performed every two weeks four times. Safty 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 Diagnosed as pancreatic or biliary tract cancer.
2. Informed about hisdiagnosis
3. 1) First-line treatment for inoperable patients. Stage IVa, IVb
2) Relase after operation Initial chemotherapy Two months after lastchemotherapy
4. HLA-A*2402 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 than3 months
9. Meet the following criteria for organ functions 1)WBC more than4,000/microliter and less than 12,000,Neutrophil more than 2,000/microliter, Platelet moret han 100,000/microliter, Hemoglobin more than 9.5g/dl 2) Serum creatinine within normal limitation 3) Serum bilirubin less than1.5 folds of the upper normallimit 4) Serum AST/GOT less than 2.5 folds of the upper normallimit 5) Serum Albumin more than3.0g/dl
10. Pleural effusion, ascites and pericardial effusion are not detected orcontrolled.
11. Informed consent has been obtained
Key exclusion criteria 1. There is deep-seated active infection. 2,3. There are severe complications including malignant hypertention, cardiac failure, liver cirrhosis, severe DM, severe lung fibrosis, active interstitial pneumonitis. Patients who have complications that are considered inappropriate for the trial. 4. Dependent on total parenteral nutrition (TPN) 5. There are other malignancies. 6. There are hematopoietic stem cell disorders such as myelodysplastic syndorome (MDS) and myeloproliferative disorders (MPD). 7. Pregnant or lactating woman 8. Past history of severe drug allergy 9. There is severe psychiatric disorder. 10. Responsible doctor's judged the patient inappropriate for the trial.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Haruo Sugiyama
Organization Osaka University Medical
School
Division name Department of Clinical Laboratory Science
Zip code
Address 1-7, Yamada-oka, Suita City, Osaka , Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shigeo Koido
Organization Jikei University School of Medicine
Division name Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
Address
TEL
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
Organization
Division
Category of Funding Organization
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 21 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
2009 Year 12 Month 07 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 01 Day
Last follow-up date
2015 Year 02 Month 21 Day
Date of closure to data entry
2015 Year 02 Month 21 Day
Date trial data considered complete
2015 Year 02 Month 21 Day
Date analysis concluded
2015 Year 02 Month 21 Day

Other
Other related information

Management information
Registered date
2010 Year 08 Month 21 Day
Last modified on
2013 Year 02 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004915

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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