UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004063 |
|---|---|
| Receipt number | R000004742 |
| Scientific Title | A phase I study of combination therapy with WT1 peptide-pulsed dendritic cells and gemcitabine for advanced pancreatic and biliary tumors |
| Date of disclosure of the study information | 2010/08/18 |
| Last modified on | 2018/04/26 09:43:57 |
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Basic information
Public title
A phase I study of combination therapy with WT1 peptide-pulsed dendritic cells and gemcitabine for advanced pancreatic and biliary tumors
Acronym
Combination therapy with WT1 peptide-pulsed dendritic cells and gemcitabine
Scientific Title
A phase I study of combination therapy with WT1 peptide-pulsed dendritic cells and gemcitabine for advanced pancreatic and biliary tumors
Scientific Title:Acronym
Combination therapy with WT1 peptide-pulsed dendritic cells and gemcitabine
Region
| Japan |
Condition
Condition
pancreatic and biliary tumors
Classification by specialty
| Hepato-biliary-pancreatic medicine |
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-pulsed dendritic cells and gemcitabine for advanced pancreatic and biliary tumors. 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. Clinical 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.
Dendritic cell pulsed WT1 peptide vaccination
The patient is intradermally injected with WT1 peptide (HLA-A*2402-restricted, 9-mer modified peptide (p235-243: CYTWNQMN) , HLA-A*02401-restricted peptide (p126-134: RMFPNAPYL), 16-mer WT1 helper peptide (p332-347: KRYFKLSHLQMHSRKH) pulsed dendritic cells over 1 hour after administration of gemsitabine. WT1 peptide pulsed dendritic cells are performed every two weeks four times.
Safety 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 pancreatic or biliary cancer.
2. Informed about hisdiagnosis
3.
1) First-line treatment for inoperable patients. Stage IVa, IVb
2) Relapse after operation Initial chemotherapy Two months after last chemotherapy
4. HLA-A*2402, 0201, 0206, DRB1*0405, DRB1*0803, DRB1*1502, DRB1*1501, DPB1*0901, or DPB1*0501 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 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 9.5 g/dl
2) Serum creatinine within normal limitation
3) Serum bilirubin less than1.5 folds of the upper normal limit
4) Serum AST/ALT less than 2.5 folds of the upper normal limit
5) Serum Albumin more than 3.0g/dl
10. Patients can tolerate blood component collection (apheresis) to collect peripheral blood mononuclear cells.
11. Pleural effusion, ascites and pericardial effusion are not detected.
12. Informed consent has been obtained.
Key exclusion criteria
1. There is deep-seated active infection.
2. There are severe complications including malignant hypertension, cardiac failure, liver cirrhosis, severe DM, severe lung disease, active interstitial pneumonitis. 3. Patients who have complications are considered in appropriate 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 syndrome (MDS) and myeloproliferative disorders (MDP). 7. Pregnant or lactating woman. 8. Past history of severe drug allergy. 9. There is severe psychiatric disease. 10. Responsible doctor's judged the patient inappropriate for the trial.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ohkusa Toshifumi |
Organization
Jikei University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
Address
163-1 Kashiwa-shita, Kashiwa, Chiba 277-8564 Japan
TEL
0471-64-1111
ohkusa@jikei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koido Shigeo |
Organization
Jikei University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
Address
163-1 Kashiwa-shita, Kashiwa, Chiba 277-8567 Japan
TEL
+81-4-7164-1111
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 etc
Organization
Division
Category of Funding Organization
Other
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 | 18 | 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
| 2010 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 08 | Month | 18 | Day |
Last modified on
| 2018 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004742
