UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003157 |
|---|---|
| Receipt number | R000003826 |
| Scientific Title | Phase II study of personalized peptide vaccination in bladder cancer patients progressing after first-line platinum-containing regimen |
| Date of disclosure of the study information | 2010/02/10 |
| Last modified on | 2014/08/24 11:21:05 |
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Basic information
Public title
Phase II study of personalized peptide vaccination in bladder cancer patients progressing after first-line platinum-containing regimen
Acronym
Phase II study of peptide vaccination in bladder cancer patients progressing after chemotherapy
Scientific Title
Phase II study of personalized peptide vaccination in bladder cancer patients progressing after first-line platinum-containing regimen
Scientific Title:Acronym
Phase II study of peptide vaccination in bladder cancer patients progressing after chemotherapy
Region
| Japan |
Condition
Condition
Bladder cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Up to 4 from the 31 candidate peptides, to which peptide-specific IgGs are detected before vaccination, are administered to bladder cancer patients progressing after first-line platinum-containing regimen. The aim of the study is to investigate the safety, immunological responses and antitumor activity.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Evaluation of antitumor activity (progression free survival) of peptide vaccination.
Key secondary outcomes
1.Evaluation of response rate and long-term prognosis (overall survival).
2.Adverse effects of peptide vaccination / The safety of the protocol is evaluated based on the NCI-CTCAE (v 4.0).
3.Evaluation of immunological responses (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
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Arm 1: personalized peptide vaccine plus best supportive care (BSC)
(1st treatment: total 8 times, every weeks)
Day 1: Select peptide candidates (up to 4), to which peptide-specific IgGs are detected before vaccination, and administer peptides that showed the highest reactivity. Individually emulsify these peptides with IFA and subcutaneously inject (3.0 mg/peptide).
Day 8, 15, 22, 29, 36, 43, 50: Inject subcutaneously the same peptides as those of the 1st injection at the same dose.
Day 50: First evaluation.
The 1st treatment (total 8 times, every weeks) is finished. Clinical response is evaluated by RESIST criteria.
(2nd treatment: total 4 times, every 2 weeks)
Day 1: Select peptide candidates (up to 4), to which peptide-specific IgGs are detected before vaccination, and administer peptides.
Day 15, 29, 43 : Inject subcutaneously the same peptides as those of the 1st injection at the same dose.
Day 43: Second evaluation.
The 2nd treatment (total 4 times, every 2 weeks) is finished. Clinical response is evaluated by RESIST criteria.
BSC is administered according to institutional standards (including palliative radiotherapy, antibiotics, analgesics, corticosteroids, and transfusion) during the vaccination.
(Follow-up)
Duration of follow-up is 8 months after protocol treatment.
Interventions/Control_2
Arm 2: Best supportive care (BSC)
BSC is administered according to institutional standards (including palliative radiotherapy, antibiotics, analgesics, orticosteroids, and transfusion) for 16 weeks.
Day 57:First evaluation.
Clinical response is evaluated by RESIST criteria.
Day 113: Second evaluation
Clinical response is evaluated by RESIST criteria.
(Follow-up)
Duration of follow-up is 8 months after protocol treatment.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The subjects must satisfy the following conditions.
1) Patients require histologically confirmed locally advanced or metastatic bladder cancer and documented after first-line platinum containing chemotherapy.
2) Patients in arm 1 must be positive for HLA-A2, -A24, -A26 or HLA-A3 super type(A3, A11, A31 or A33).
3) Patients in arm 1 must have IgG reactive to at least two of peptide candidates.
4) Prior treatment are allowed and must
complete 4 weeks before random
assignment with full recovery of related
toxicity.
5) Patients must be at a score level
of 0-1 of performance status (PS) (ECOG).
6) Patients must be expected to survive more than 3 months.
7) Patients must satisfy the followings:
WBC > 2,500/mm3
Lymphocyte > 1,000/mm3
Hb > 8.0g/dl
Platelet > 100,000/mm3
Serum Creatinine < 2 x upper limit of normal
Total Bilirubin > 2 x upper limit of normal
8) Patients require to have adequate organ function.
9) Patients must be more 18 year-old.
10) 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 do not accept contraception during the 1st vaccination to 70 days after the last vaccination.
4) Patients who are judged inappropriate for the clinical trial by doctors.
Target sample size
80
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, Department of Urology
Zip code
Address
Asahi-machi 67, Kurume, Fukuoka 830-0011, Japan
TEL
0942-31-7989
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Yamada |
Organization
Kurume University
Division name
Research Center for Innovative Cancer Therapy, Cancer Vaccine Division
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
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
Hirosaki University , Dokkyou University, Kitasato University, Kinki University, Okayama University, Kyushu University, Fukuoka University, Kumamoto University
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(福岡県)、弘前大学病院(青森県)、獨協医科大学越谷病院(埼玉県)、北里大学病院(神奈川県)、近畿大学病院(大阪府)、岡山大学病院(岡山県)、九州大学病院(福岡県)、福岡大学病院(福岡県)、熊本大学病院(熊本県)
Kurume University Hospital, Hirosaki University Hospital, Dokkyo University Koshigaya Hospital, Kitasato University Hospital, Kinki University Hospital, Okayama University Hospital, Kyusu University Hospital, Fukuoka University Hospital, Kumamoto University Hospital
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 02 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2010 | Year | 01 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
| 2014 | Year | 04 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 02 | Month | 09 | Day |
Last modified on
| 2014 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003826
