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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001187
Receipt No. R000001428
Scientific Title WT1 peptide-based vaccination combined with Gemcitabine for advanced pancreas cancer
Date of disclosure of the study information 2008/06/20
Last modified on 2014/11/27

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Basic information
Public title WT1 peptide-based vaccination combined with Gemcitabine for advanced pancreas cancer
Acronym WT1 peptide-based vaccination combined with Gemcitabine for advanced pancreas cancer
Scientific Title WT1 peptide-based vaccination combined with Gemcitabine for advanced pancreas cancer
Scientific Title:Acronym WT1 peptide-based vaccination combined with Gemcitabine for advanced pancreas cancer
Region
Japan

Condition
Condition pancreas cancer
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Safety
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes Safety
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 1. Diagnosed as pancreas cancer.
2. Informed about his diagnosis
3. 1) First-line treatment for inoperable patients.
Stage IVa, IVb
2) Relase after operation
Initial chemotherapy
Two months after last chemotherapy
4. HLA-A*2402 positive
5. Having evaluable diaseas 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 9.5g/dl
2) Serum creatinine within normal limitation
3) Serum bilirubin less than 1.5 folds of the upper normal limit
4) Serum AST/GOT less than 2.5 folds of the upper normal limit
5) Serum Albumin more than 3.0g/dl

10. Pleural effusion, ascites and pericardial effusion are not detected or
controlled.

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 fiblosis, 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 myelodisplastic 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 doctors judged the patient inappropriate for the trial
Target sample size 18

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 06-6879-2593
Email sugiyama@sahs.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sumiyuki Nishida
Organization Osaka University Medical School
Division name Department of Cancer Immunotherapy
Zip code
Address 2-2, Yamada-oka, Suita City, Osaka, Japan
TEL 06-6879-3676
Homepage URL
Email sumiyuki-n@imed3.med.osaka-u.ac.jp

Sponsor
Institute Department of Cancer immunotherapy, Osaka University Medical School
Institute
Department

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

Other related organizations
Co-sponsor THE JIKEI UNIVERSITY
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
2008 Year 06 Month 20 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/24509173
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
2007 Year 06 Month 06 Day
Date of IRB
Anticipated trial start date
2008 Year 03 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
2012 Year 03 Month 01 Day
Date trial data considered complete
2012 Year 03 Month 01 Day
Date analysis concluded
2013 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2008 Year 06 Month 13 Day
Last modified on
2014 Year 11 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001428

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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