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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000910
Receipt No. R000001098
Scientific Title Phase I Study of Gemcitabine-Combined WT1 Peptide Vaccine Treatment for Patients with Advanced Pancreas or Biliary Duct Cancer
Date of disclosure of the study information 2007/11/28
Last modified on 2009/10/20

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Basic information
Public title Phase I Study of Gemcitabine-Combined WT1 Peptide Vaccine Treatment for Patients with Advanced Pancreas or Biliary Duct Cancer
Acronym Gemcitabine+WT1 Peptide Vaccine Treatment for Pancreas or Biliary Duct Cancer
Scientific Title Phase I Study of Gemcitabine-Combined WT1 Peptide Vaccine Treatment for Patients with Advanced Pancreas or Biliary Duct Cancer
Scientific Title:Acronym Gemcitabine+WT1 Peptide Vaccine Treatment for Pancreas or Biliary Duct Cancer
Region
Japan

Condition
Condition Advanced pancreatic cancer or biliary duct cancer
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation of safety and dose-finding study of combined chemoimmunotherapy using gemcitabine and WT1 peptide mixed with Montanide ISA-51 VG Adjuvant for patients with advanced pancreatic cancer or biliary duct cancer with no indication of curative operation.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Evaluation of safety and dose-finding study
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Gemcitabine is administered on days 1, 8, and 15 and WT1 peptideis injected on days 8 and 22. The treatment is repeated two times. (28 days cycle)
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients with pancreatic cancer or biliary duct cancer, which was histologically confirmed as adenocarcinoma or adenosquamous carcinoma.
2) Patients with locally advanced or recurrent tumor with no indication of curative operation regardless presence or absence of measurable lesion
3) Gemcitabine-naive patients
4) HLA-A0201 or HLA-A2402 genotype
5) Age older than 20 years
6) ECOG PS: 0-2
7) Expected survival of => 2 months
8) Well preserved major organ function
WBC: =>3,000/mm3, Neutrophils: =>1,500/mm3,
Platelet: =>100K /mm3, Total bilirubin: <=3.0 mg/dL, Albumin: =>3.0 g/dL, ASTand ALT: <=150IU/l, Serum creatinine:<=1.5 mg/dL
10) Available signed informed consent
Key exclusion criteria 1) Active infection excluding hepatitis virus
2) Significant complications which include cardiac dysfunction, renal failure, liver failure, active peptic ulcer, paralytic ileus, uncontrolled diabetes, etc.
3) Moderate ascites or thoracic effusion which required centesis
4) CNS involvement
5) Serious neuropsychological complications
6) Pregnant or feeding female, female who want to have a baby
7) Symptomatic interstitial pneumonitis or fibrosis confirmed by chest X-ray
8) Complicated myelodysplastic syndrome (MDS), myeloproliferative diseases (MPD) or chronic myelocytic leukemia (CML)
9) History of autoimmune disorders
10) Receiving immunosuppresants or steroids
11) Other conditions that physicians deny patient participation
Target sample size 36

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuji Heike
Organization National Cancer Center Hospital
Division name Department of Clinical Trial Coordination and Developmental Therapeutics
Zip code
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL 03-3542-2511
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization National Cancer Center Hospital
Division name Support Center for Patients and Families
Zip code
Address
TEL 03-3547-5293
Homepage URL
Email

Sponsor
Institute Department of Clinical Trial Coordination and Developmental Therapeutics
National Cancer Center Hospital
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2007 Year 11 Month 28 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
2007 Year 10 Month 22 Day
Date of IRB
Anticipated trial start date
2007 Year 11 Month 01 Day
Last follow-up date
2010 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2007 Year 11 Month 28 Day
Last modified on
2009 Year 10 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001098

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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