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Recruitment status Completed
Unique ID issued by UMIN UMIN000004919
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email s.asahara@chibatoku.or.jp

Sponsor
Institute Chiba Tokushukai Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005851


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