UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004919 |
|---|---|
| Receipt number | R000005851 |
| Scientific Title | Cancer vaccine therapy using epitope peptide from KIF20A restricted to HLA-A*24 in patients with pancreatic cancer refractory to standard therapy (Phase I/II study) |
| Date of disclosure of the study information | 2011/01/20 |
| Last modified on | 2014/03/01 18:29:13 |
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Basic information
Public title
Cancer vaccine therapy using epitope peptide from KIF20A restricted to HLA-A*24 in patients with pancreatic cancer refractory to standard therapy (Phase I/II study)
Acronym
Cancer vaccine therapy using epitope peptide from KIF20A restricted to HLA-A*24 in patients with pancreatic cancer refractory to standard therapy (Phase I/II study)
Scientific Title
Cancer vaccine therapy using epitope peptide from KIF20A restricted to HLA-A*24 in patients with pancreatic cancer refractory to standard therapy (Phase I/II study)
Scientific Title:Acronym
Cancer vaccine therapy using epitope peptide from KIF20A restricted to HLA-A*24 in patients with pancreatic cancer refractory to standard therapy (Phase I/II study)
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate safety and clinical efficacy on cancer vaccination therapy using HLA-A*24 restricted epitope peptide from KIF20A in patient with refractory pancreatic cancer to standard therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
1.Safety and adverse effect
2.Antitumor effect
Key secondary outcomes
1.Immunological response
Peptide specific CTL response in vitro
Antigen cascade
2.Clinical efficacy
Overall survival
Progression free survival
Median survival time
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
| Vaccine |
Interventions/Control_1
peptide 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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients who have unresectable / recurrent pancreatic cancer to be refractory to standard therapy or unable to continue standard therapy due to side effect
2.obtains lesion which can be evaluated by RECIST
3. Performance status (ECOG) of the patients are 0-2
4.Age between 20 to 85
5.Patients who can expect the survival of two months or more
6.Patients who have undergone operation, and recovered the influence by surgery. Or two weeks or more have passed since pre-medical treatment
7. WBC count more than 3000/mm3(or neutrophil count more than 1000/mm3), less than 15000/mm3. Plt count more than 75000/mm3. AST and ALT less than 150IU/L. T-Bil less than 3.0mg/dl Creatinine less than 2.0mg/dl
8.Able and willing to give valid written informed concent
Key exclusion criteria
1.Pregnancy
2.Lactation
3.Patients having will of pregnancy.
4.Patients have uncontrollable severe infectional diseases.
5.Patients who are treated with steroid or immunotherapy during clinical trial.
6.Patients have uncontrollable associated cancer.
7.Patients who have non-recovered injury.
8.Patients judged inappropriated by doctors.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shingo Asahara |
Organization
Chiba Tokushukai Hospital
Division name
Internal medicine
Zip code
Address
1-27-1 Narashinodai, Funabashi, Chiba
TEL
047-466-7111
s.asahara@chibatoku.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shingo Asahara |
Organization
Chiba Tokushukai Hospital
Division name
Internal medicine
Zip code
Address
1-27-1 Narashinodai, Funabashi, Chiba
TEL
047-466-7111
Homepage URL
s.asahara@chibatoku.or.jp
Sponsor or person
Institute
Chiba Tokushukai Hospital
Institute
Department
Personal name
Funding Source
Organization
Chiba Tokushukai Hospital
Organization
Division
Category of Funding Organization
Self funding
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
| 2011 | Year | 01 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.translational-medicine.com/content/11/1/291
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
| 2009 | Year | 03 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 09 | Month | 16 | Day |
Date of closure to data entry
| 2012 | Year | 09 | Month | 16 | Day |
Date trial data considered complete
| 2012 | Year | 09 | Month | 16 | Day |
Date analysis concluded
| 2013 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 01 | Month | 20 | Day |
Last modified on
| 2014 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005851
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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