UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005329 |
|---|---|
| Receipt number | R000006331 |
| Scientific Title | A randomized clinical trial of personalized peptide vaccination with oral low-dose metronomic cyclophosphamide for metastatic castration-resistant prostate cancer (CRPC) |
| Date of disclosure of the study information | 2011/04/01 |
| Last modified on | 2019/12/06 15:50:27 |
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Basic information
Public title
A randomized clinical trial of personalized peptide vaccination with oral low-dose metronomic cyclophosphamide for metastatic castration-resistant prostate cancer (CRPC)
Acronym
Personalized peptide vaccination with metronomic cyclophosphamide for metastatic CRPC
Scientific Title
A randomized clinical trial of personalized peptide vaccination with oral low-dose metronomic cyclophosphamide for metastatic castration-resistant prostate cancer (CRPC)
Scientific Title:Acronym
Personalized peptide vaccination with metronomic cyclophosphamide for metastatic CRPC
Region
| Japan |
Condition
Condition
Castration-resistant prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate ability of oral metronomic cyclophosphamide with personalized peptide vaccination to deplete immuno-suppression cells in metastatic CRPC patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Evaluation of ability of oral metronomic cyclophosphamide with personalized peptide vaccination to deplete immuno-suppression cells.
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.
3. Evaluation of immunological responses (cytotoxic T lymphocytes [CTL]and anti-peptide IgG) before and after peptide vaccination.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
A: Personalized peptide vaccination with oral metronomic cyclophosphamide treatment
Select peptide candidates (up to 4), 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. Start oral use of cyclophosphamide 1T (1X) (50 mg/day, 50 days) on the same day with peptide vaccination. 1st treatment: total 8 times, every weeks)
After the first cycle of 8 vaccinations, the peptides were re-selected according to the titers of peptide-specific IgG at every cycle of 8 vaccinations and administered at 2, 3, or 4 week intervals until unacceptable toxicity or withdrawal of consent.
Interventions/Control_2
B: Personalized peptide vaccine alone
Select peptide candidates (up to 4), 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. After the first cycle of 8 vaccinations, the peptides were re-selected according to the titers of peptide-specific IgG at every cycle of 8 vaccinations and administered at 2, 3, or 4 week intervals until unacceptable toxicity or withdrawal of consent.
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 metastatic castration-resistant prostate cancer after standard treatment.
2) Patients must be positive for HLA-A2, HLA-A24 or HLA-A3 super type.
3) Patients must have IgG reactive to at least two of 31 peptide candidates.
4) Patients must be at a score level
of 0-1 of performance status (PS) (ECOG).
5) Patients must be expected to survive more than 3 months.
6) Patients must satisfy the followings:
WBC > 2,500/mm3
Lymphocyte > 1,000/mm3
Hb > 8.0g/dl
Platelet > 100,000/mm3
Serum Creatinine < 2.5 x upper limit of normal
Total Bilirubin < 2 x upper limit of normal
7) Patients must be more 20 year-old.
8) 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) Patients with the past history of severe allergic reactions.
3) Patients who are judged inappropriate for the clinical trial by doctors.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Noguchi |
Organization
Kurume University School of Medicine
Division name
Research Center for Innovative Cancer Therapy, Division of Clinical Research Department of Urology
Zip code
830-0011
Address
Asahi-machi 67, Kurume, Japan
TEL
0942-31-7989
noguchi@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Yamada |
Organization
Kurume University School of Medicine
Division name
Research Center for Innovative Cancer Therapy, Cancer Vaccine Department Division
Zip code
830-0011
Address
Asahi-machi 67, Kurume, Japan
TEL
0942-31-7572
Homepage URL
akiymd@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University School of medicine, Department of Immunology and immunotherapy
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education, Culture, Sports, Science, and Technology, Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Kurume University
IRB Contact (For public release)
Organization
Kurume University School of Medicine
Address
67 Asahi-machi, Kurume, Japan
Tel
0942-35-3311
sangaku@kurume-u.ac.jp
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 (福岡県) Kurume University Hospital
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | Month | 01 | 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
| 2011 | Year | 03 | Month | 28 | Day |
Date of IRB
| 2011 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 03 | Month | 28 | 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=R000006331
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