UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001187 |
|---|---|
| Receipt number | 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 15:33:52 |
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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
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
sumiyuki-n@imed3.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Cancer immunotherapy, Osaka University Medical School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001428
