UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000910 |
|---|---|
| Receipt number | 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 17:14:20 |
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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
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
Sponsor or person
Institute
Department of Clinical Trial Coordination and Developmental Therapeutics
National Cancer Center Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001098
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