UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002746 |
|---|---|
| Receipt number | R000003339 |
| Scientific Title | Immunological evaluation of personalized peptide vaccination monotherapy in patients with castration-resistant prostate cancer |
| Date of disclosure of the study information | 2009/11/11 |
| Last modified on | 2009/11/11 12:45:15 |
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Basic information
Public title
Immunological evaluation of personalized peptide vaccination monotherapy in patients with castration-resistant prostate cancer
Acronym
Personalized peptide vaccination monotherapy in patients with castration-resistant prostate cancer
Scientific Title
Immunological evaluation of personalized peptide vaccination monotherapy in patients with castration-resistant prostate cancer
Scientific Title:Acronym
Personalized peptide vaccination monotherapy in patients with castration-resistant prostate cancer
Region
| Japan |
Condition
Condition
Castration-resistant prostate cancer
Classification by specialty
| Clinical immunology | Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the safety and efficacy of personalized peptide vaccination monotherapy in metastatic CRPC patients without any other therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Toxicity evaluation.
Key secondary outcomes
Immunological and clinical responses
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
patient-oriented peptide vaccinations for patients with castration resistant prostate cancer
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
| 80 | years-old | > |
Gender
Male
Key inclusion criteria
Castration resistant prostate cancer
HLA-A2 or -A24 positive
100 % informed consent
PS(ECOG):0 or 1
Life expectancy:more than 3 months
Wash out: more than 4 weeks
Key exclusion criteria
Any of other cancers
Infections (ex. HBV, HCV, HIV)
Other serious disorders (ex. heart, lung, pulmonary, kidney, allergic diseases)
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirotsugu Uemura |
Organization
Kinki University School of Medicine
Division name
Urology
Zip code
Address
377-2 Ohno-Higashi, Osaka-Sayama, Osaka, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirotsugu Uemura |
Organization
Kinki University School of Medicine
Division name
Urology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Department of Urology Kinki University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Science Research (B) from the Japan Society for the Promotion of Science and from the Research Center of Innovative Cancer Therapy of the 21st Century COE Program.
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of Urology, Kinki University School of Medicine
Name of secondary funder(s)
Department of Urology, Kinki University Scool of Medicine
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
| 2009 | Year | 11 | Month | 11 | 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
| 2002 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2003 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 12 | 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
| 2009 | Year | 11 | Month | 11 | Day |
Last modified on
| 2009 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003339
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| Registered date | File name |
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| Registered date | File name |
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