UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005248 |
|---|---|
| Receipt number | R000006238 |
| Scientific Title | WT1 peptide-based cancer vaccine combined with gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: a randomised, multicenter, phase 2 clinical study |
| Date of disclosure of the study information | 2011/04/01 |
| Last modified on | 2016/09/17 12:15:03 |
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Basic information
Public title
WT1 peptide-based cancer vaccine combined with gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: a randomised, multicenter, phase 2 clinical study
Acronym
Advanced pancreatic cancer GEM+WT1 vaccine RCT P2
Scientific Title
WT1 peptide-based cancer vaccine combined with gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: a randomised, multicenter, phase 2 clinical study
Scientific Title:Acronym
Advanced pancreatic cancer GEM+WT1 vaccine RCT P2
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Investigate the efficacy and safety of the combination therapy with gemcitabine and WT1 peptide-based cancer vaccine in the patients with advanced pancreatic cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
1-year overall survival rate
Key secondary outcomes
Overall Survival(OS), 6-month OS rate, 1.5-year OS rate, Progression Free Survival, Disease control rate, Clinical benefit response, QOL, toxic effects, immunological monitoring, and non-immunological monitorings
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Combination therapy with GEM+WT1 vaccine
1) Gemcitabine: 1000mg/m2, day1, 8, 15, q28 intravenous injection, 30min.
2) WT1 peptide-based cancer vaccine: 3mg of WT1 peptide/body, day1, day15, q28 intradermal injection
2)-1 WT1 peptide
mp235: HLA-A*2402 restricted WT1peptide
or
np126: HLA-A*0201 restricted WT1peptide
2)-2 Adjuvant
Montanide ISA51
Interventions/Control_2
Gemcitabine alone
1) Gemcitabine: 1000mg/m2, day1, 8, 15, q28 intravenous injection, 30min.
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Diagnosed as pancreatic cancer
2) unresectable (UICC-stage III or IV) or recurrent pancreatic cnacer
3) Histologically or Cytologically proven pancreatic ductal adenocarcinoma
4) Karnofsky Performance Status 80-100%
5) Aged 20 to 79 years old
6) HLA-A*2402, A*0201
7) Without CNS metastases
8) Without moderate or more ascites / pleuraleffusion
9) No previous treatment against unresectable or recurrent advanced pancreatic cancer
10) No previous operation, chemotheraoy, or radiotherapy against any other malignancies, and no recurrence at least within 5 years
11) Able to eat by mouth
12) Adequate organ function
13) Written informed consent
Key exclusion criteria
1) Simultaneous or metachronous (within 5 years) double cancers, with exception of intramucosal tumor curable with local therapy
2) Pregnant or lactating women or women fo childearing potential, and men who want to get partner pregnat
3) Psychosis
4) Patients requiring systemic immunosuppresive agents, or moderate or higher dose of steroid with exception of usage for cancer pain
5) Pulmonary fibrosis or interstitial pneumonitis
6) Active bacterial or fungal infection
7) Severe complications
8) MDS, MDS/MPD, MPD
9) Severe drug allergy
10) Inadequate physical condition, as diagnosed by the primary physician
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Haruo Sugiyama |
Organization
Osaka university Graduate school of Medicine
Division name
Functional Diagnostic 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 Graduate school of Medicine
Division name
Cancer Immunotherapy
Zip code
Address
2-2, Yamada-oka, Suita City, Osaka, Japan
TEL
06-6879-3676
Homepage URL
http://sahswww.med.osaka-u.ac.jp/~hmtonc/vaccine/
sumiyuki-n@imed3.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Cancer Immunotherapy, Osaka university Graduate 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
Japan
Other related organizations
Co-sponsor
Dept. Surgery, Osaka Univ. graduate school of Med.
Jikei University
Tohoku Univ. graduate school of Med.
Kansai Medical University
Kyoto Prefectural Univ. Medicine
Toho University Omori Medical center
Kanagawa Cancer Center
Sendai Open Hospital
Teikyo University Hospital
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
大阪大学医学部附属病院（大阪府）、東京慈恵会医科大学附属柏病院（千葉県）、東北大学病院（宮城県）、関西医科大学附属枚方病院（大阪府）、京都府立医科大学附属病院（京都府）、東邦大学医療センター大森病院（東京都）、神奈川県立がんセンター（神奈川県）、仙台オープン病院（宮城県）、帝京大学医学部附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Main results already published
Date of protocol fixation
| 2011 | Year | 03 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 03 | Month | 14 | Day |
Last modified on
| 2016 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006238
