UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004081 |
|---|---|
| Receipt number | 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 17:48:20 |
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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
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
shigeo_koido@jikei.ac.jp
Sponsor or person
Institute
Department of Internal
medicine, Division of
Gastroenterology and
Hepatology, Kashiwa Hospital,
Jikei University School of
Medicine
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
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004915
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