UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001515 |
|---|---|
| Receipt number | R000001824 |
| Scientific Title | Pilot study of WT1 peptide vaccine therapy for chemorefractory advanced pancreatic cancer |
| Date of disclosure of the study information | 2008/11/25 |
| Last modified on | 2011/01/05 15:43:37 |
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Basic information
Public title
Pilot study of WT1 peptide vaccine therapy for chemorefractory advanced pancreatic cancer
Acronym
Wt1 peptide vaccine for pancreatic cancer (PDAC-WT1).
Scientific Title
Pilot study of WT1 peptide vaccine therapy for chemorefractory advanced pancreatic cancer
Scientific Title:Acronym
Wt1 peptide vaccine for pancreatic cancer (PDAC-WT1).
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the effectiveness of WT1 peptide (mp235-243) vaccine in combination with prior chemortherapy for chemorefractory pancreatic cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Safty and toxicity
Tumor response (Disease control)
Key secondary outcomes
Immune response
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Combination of 8 weeks of WT1 peptide vaccine with concurrent chemotherapy
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients witth advanced or recurrent pancreatic cancer that is progressive with standard chemotherapy. Any regimen of prior chemotherapy is acceptalble.
2) Pancreatic cancer should be histologically confirmed and informed to the patient.
3) Patients with HLA-A2402.
4) Any prior surgical treatment, chemotheraphy, radiation therapy, immunotherapy other than WT1 is acceptable.
5) There should be at least two weeks from thea last chemotherapeutic administration.
6) Patients with measreable disease acccording to the RECIST criteria.
7) Patints should be 20-years-old or older and less than 80-years-old.
8) Patients with Karnofsky Performance status of 50 or more.
9) Patients whose survival is expected 3 months or longer.
10) Patients with organ function preserved as indecated below.
WBC >= 3,000/microL and <12,000/microL
Neutrophil >= 1,500/microL
Platelets >= 50,000/microL
Hemoglobin >= 9.0g/dL
AST(GOT), ALT(GPT) < 5x Institutional upper limit.
Total bilirubin <5x Institutional upper limit.
Alubumin >= 2.5g/dL
Creatinin < Instititional Upper Limit
11) Patients with written informed consent on this pilot study.
Key exclusion criteria
1) Patients with uncontrollable infection including active tuberculosis.
2) Patients with severe concurrent disease including malignant hypertension, congestive heart failure, severe coronary disorder, myocardial infarction within 3 months, severe liver cirrhosis, uncontrollable diabetes mellitus, lung fibrosis, interstitial pneumonia, prominent peripheral edeme.
3) Patients who showed severe complication (Grade 3 or more severe according to CTCAE version 3.0) with prior chemotherapy.
4) Patients who require 24 h or more intravenous, transcatheteric nutrition or total parenteral nutrition due to GI symptom.
5) Patients with double cancer.
6) Patients with myelo-dysplastic syndrome or myeopoliferative disease.
7) Pregnant or supposed to be pregnant patient.
8) Patients with past history of severe drug allergy.
9) Patients with severe mental disorder.
10) Patients who is not recommended by attending physician, or trial conductor.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Egawa |
Organization
Tohoku University Hospital
Division name
Division of Hepato-Biliary-Pancreatic Surgery
Zip code
Address
1-1 Seiryo Aoba, Sendai 980-8574, JAPAN
TEL
022-717-7205
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichi Egawa |
Organization
Tohoku University Hospital
Division name
Division of Hepato-Biliary-Pancreatic Surgery
Zip code
Address
1-1 Seiryo Aoba, Sendai 980-8574, JAPAN
TEL
022-717-7205
Homepage URL
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society for Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 11 | Month | 25 | 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
| 2008 | Year | 09 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 11 | Month | 19 | Day |
Last modified on
| 2011 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001824
