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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000005248
Receipt No. 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

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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
Email 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/
Email sumiyuki-n@imed3.med.osaka-u.ac.jp

Sponsor
Institute Department of Cancer Immunotherapy, Osaka university Graduate school of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006238

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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