UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019879 |
|---|---|
| Receipt number | R000022966 |
| Scientific Title | A phase II clinical trial of personalized peptide vaccination in combination with metformin for castration-resistant prostate cancer (CRPC) |
| Date of disclosure of the study information | 2015/11/24 |
| Last modified on | 2019/12/06 15:54:26 |
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Basic information
Public title
A phase II clinical trial of personalized peptide vaccination in combination with metformin for castration-resistant prostate cancer (CRPC)
Acronym
Personalized peptide vaccination with metformin for CRPC
Scientific Title
A phase II clinical trial of personalized peptide vaccination in combination with metformin for castration-resistant prostate cancer (CRPC)
Scientific Title:Acronym
Personalized peptide vaccination with metformin for CRPC
Region
| Japan |
Condition
Condition
Castration-resistant prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of study is to investigate the immunity-enhancing effects, safety , clinical efficacy of personalized peptide vaccination in combination with metformin for castration-resistant prostate cancer patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Assessment of immune responses by measurement of cytotoxic T lymphocytes (CTL)and anti-peptide IgG) before and after peptide vaccination with metformin.
Key secondary outcomes
1.Evaluation of long-term prognosis (progression free survival and overall survival).
2.Adverse effects of peptide vaccination / The safety of the protocol is evaluated based on the NCI-CTC.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Vaccine |
Interventions/Control_1
1st cycle:
(Personalized peptide vaccination alone)
4 peptide vaccines are selected from 31 peptide candidates restricted by HLA-class I, to which peptide-specific IgGs are detected before vaccination, and administer peptides (maximum 4) that showed the highest reactivity. Emulate these peptides individually and subcutaneously inject them separately (3.0 mg/1.5-3.0 ml/peptide) every 1 week interval:
total 8 times, every weeks.
After 1st cycle:
(Personalized peptide vaccination in combination with metformin)
Start oral use of metformin (500mg/day, 2X, every days) with personalized peptide vaccination.
If the patients want to continue the vaccination after completion of the second cycle of 8 vaccinations, the peptide vaccination with metformin will be allowed to continue (every 3-4 weeks) until unacceptable toxicity or withdrawal of consent.
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
Key inclusion criteria
The subjects must satisfy the following conditions.
1) Patients must be diagnosed as prostate cancer pathologically at the initial treatment. The patients must be suffering from castration-resistant prostate cancer after standard treatment.
2) Patients have not been diagnosed as diabetes, and patients must satisfy the followings:
HbA1c < and = 6.5%
Patients do not receive medical therapy
using the diabetes medicine (including an oral hypoglycemic drug, the insulin
therapy).
3) Patients must be at a score level
of 0-1 of performance status (PS) (ECOG).
4) Patients must be positive for HLA-A2, HLA-A24 or HLA-A3 super type.
5) Patients must have IgG reactive to at least two of peptide the candidate peptides restricted to the patient's HLA types.
6) Patients must satisfy the followings:
WBC >and= 2,500/mm3
Lymphocyte >and=1,000/mm3
Hb >and= 8.0g/dl
Platelet >and= 80,000/mm3
Serum Creatinine <and= 1.5x upper limit of normal
Total Bilirubin <and=2x upper limit of normal
AST, ALT <and = 2x upper limit of normal
7) Patients must be more 20 year-old.
8) Patients must be expected to survive more than 3 months.
9) Written informed consent must be obtained from patients.
Key exclusion criteria
The following patients must be excluded:
1) Patients with severe symptoms (active and severe infectious disease, circulatory disease, respiratory disease, kidney disease, immunodeficiency, disturbance of coagulation).
2)Active double cancer (synchronous double cancer and metachronous double cancer within 5 disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) judged to have been cured with local treatment.
3) Patients with the past history of severe allergic reactions.
4) Patients who do not accept contraception from the 1st vaccination until 70 days after the last vaccination.
5) Patients who are judged inappropriate for entry to this clinical trial by doctors.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masanori Noguchi |
Organization
Kurume University School of Medicine
Division name
Research Center for Innovative Cancer Therapy, Division of Clinical Research
Zip code
Address
Asahi-machi 67, Kurume, Fukuoka 830-0011, Japan
TEL
0942-31-7989
noguchi@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Yamada |
Organization
Kurume University School of Medicine
Division name
Research Center for Innovative Cancer Therapy, Division of Cancer Vaccine
Zip code
Address
Asahi-machi 67, Kurume, Fukuoka 830-0011, Japan
TEL
0942-31-7572
Homepage URL
akiymd@med.kurume-u.ac.jp
Sponsor or person
Institute
Cancer Vaccine Center, Kurume University School of medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Kurume University
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
久留米大学病院医療センター（福岡）Kurume University Medical Center (Fukuoka)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 24 | 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
| 2015 | Year | 11 | Month | 17 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 17 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 24 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 20 | Day |
Last modified on
| 2019 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022966
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