UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001242 |
|---|---|
| Receipt number | R000001514 |
| Scientific Title | Phase II clinical trial of personalized peptide vaccination for decetaxel no indicated patients with hormone-refractory prostate cancer |
| Date of disclosure of the study information | 2008/07/10 |
| Last modified on | 2017/11/17 13:05:03 |
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Basic information
Public title
Phase II clinical trial of personalized peptide vaccination for decetaxel no indicated patients with hormone-refractory prostate cancer
Acronym
Personalized peptide vaccination for hormone-refractory prostate cancer patients
Scientific Title
Phase II clinical trial of personalized peptide vaccination for decetaxel no indicated patients with hormone-refractory prostate cancer
Scientific Title:Acronym
Personalized peptide vaccination for hormone-refractory prostate cancer patients
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate clinical effects and safety of the peptide vaccine, peptides (maximum 4) among 12 peptides, which were identified as vaccine candidates for HLA-A24+ cancer patients, are administered into hormone-refractory prostate prostate cancer patients after confirmation of peptide-specific IgG in patients. Primary endpoint is overall survival of the patients, and the secondary endpoints are progression free survival, 12 month survival rate, anti-tumor effect (clinical responses), adverse effects (evaluation of safety), and immunological responses.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Overall survival of peptide vaccination with BSC will be compared with that of BSC patients who are not enrolled this study.
Key secondary outcomes
1. Progression free survival of peptide vaccination with BSC will be compared with that of BSC group.
2. 12 month survival rate of the 2 groups will be compared.
3. Anti-tumor effect (clinical responses) will be evaluated by RECIST criteria.
4. Adverse effects/safety will be evaluated by CTCAE v.3.0.
5. Evaluation of immunological effects (cytotoxic T lymphocytes (CTL), anti-peptide IgG) before and after peptide vaccination.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Vaccine |
Interventions/Control_1
<1st treatment: total 8 times, every week>
Day 1: 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. Emulsion of the peptides is subcutaneously injected (3.0 mg/1.5 mL). Simultaneous BSC treatments are accepted.
Day 8,15,22,29,36,43,50: Inject subcutaneously the same peptides as those of the 1st injection.
Day 50-64: Final evaluation.
<2nd treatment: total 8 times, every 2 weeks>
The 2nd treatment would be continued according to the patient's request. The peptides are bi-weekly injected. When adverse effects would be observed, the interval of vaccination and the doses of peptides could be modified.
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 after the treatment of castration, LH-RH analogue therapy, anti-androgen therapy, or female hormone therapy.
2. Patients must be decetaxel no indicated.
3. Patients must be at a score level of 0-2 of performance status (PS) (ECOG). Patient with PS3 is acceptable if limited to neural symptoms.
4. Patients must be positive for HLA-A24.
5. Patients must have IgG reactive to at least two of peptide candidates.
6. Patients must be expected to survive more than 3 months.
7. Patients must satisfy the followings:
WBC >3,000/mm3
Lymphocyte >900/mm3
Hb >8.0g/dL
Platelet >75,000/mm3
Serum Creatinine >2.0 mg/dL
Total Bilirubin >1.5 mg/dL
8. Patients must be more 20 years old.
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) Patients with multiple cancers
3) Patients with the past history of severe allergic reactions.
4) Patients who are not accept contraception during the 1st vaccination to 70 days after the last vaccination.
5) Patients with positive for hepatitis B or C virus.
6) Patients who are judged inappropriate for the clinical trial by doctors.
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masanori Noguchi |
Organization
Kurume University
Division name
Research Center for Innovative Cancer Therapy, Clinical Research Division
Zip code
Address
67 Asahi-machi,Kurume-shi,Fukuoka-ken 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 | Masanori Noguchi |
Organization
Kurume University
Division name
Research Center for Innovative Cancer Therapy, Clinical Research Division
Zip code
Address
67 Asahi-machi,Kurume-shi,Fukuoka-ken 830-0011 Japan
TEL
0942-31-7989
Homepage URL
akiymd@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University Research Center for Innovative Cancer Therapy, Clinical Research Division
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education, Culture, Sports, Science, and Technology, Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
The Ministry of Health, Labor and Welfare, Japan
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
| 2008 | Year | 07 | Month | 10 | 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
| 2008 | Year | 07 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 05 | 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
| 2008 | Year | 07 | Month | 10 | Day |
Last modified on
| 2017 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001514
