UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012696 |
|---|---|
| Receipt number | R000014828 |
| Scientific Title | Phase II clinical trial of combination of personalized peptide vaccination with low dose Cyclophosphamide for advanced sarcoma patients |
| Date of disclosure of the study information | 2014/01/14 |
| Last modified on | 2017/04/06 14:35:11 |
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Basic information
Public title
Phase II clinical trial of combination of personalized peptide vaccination with low dose Cyclophosphamide for advanced sarcoma patients
Acronym
Phase II clinical trial of peptide vaccination with low dose Cyclophosphamide for advanced sarcoma patients
Scientific Title
Phase II clinical trial of combination of personalized peptide vaccination with low dose Cyclophosphamide for advanced sarcoma patients
Scientific Title:Acronym
Phase II clinical trial of peptide vaccination with low dose Cyclophosphamide for advanced sarcoma patients
Region
| Japan |
Condition
Condition
sarcoma
Classification by specialty
| Medicine in general | Hematology and clinical oncology | Neurology |
| Surgery in general | Orthopedics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of study is to investigate clinical effect(Overall survival and Progression free time) of personalized peptide vaccination with Cyclophosphamide for advanced sarcoma patients
Basic objectives2
Others
Basic objectives -Others
1)Safty
2)Evaluation of Immunoresponse
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Clinical effect(Overallsurvival,Progression free time)
Key secondary outcomes
Safty,Immunoresponse
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
Select vaccine peptide(Up to 4)from 31 candidate peptides, to whichi peptide-specific IgGs are detected before vaccination.
Individually emulsify these peptides with adjuvant and subcutaneously inject(3mg/peptide)(Total 6 times, every 1 week)
Before 7 days to the pevious day from administraction of the peptide vaccine, by mouth twice a day Cyclophosphamide. The amount of once is 50mg.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The subjects must satisfy the following conditions.
1)Patients must be diagnosed as advanced sarcoma.
2)Patients must have evaluative lesion on imaging
3)Patients must be at a score level 0 or 1 of ECOG performance status.
4)Patients must have IgGs reactive to at least two of candidate peptides belongs to an apropriate group(s) for patient's HLA types.
5)Patients must be expected to survive more than 3 months.
6)Patients must satisfy the followings:
WBC is more than 2500/mm3
Lymphocytes is more than 900/mm3
Hb is more than 8.0g/dL
Platelet is more than 50000/mm3
Serum Creatinine is less than 2.0mg/dL
Serum Total Bilirubin is less than 2.5mg/dL
7)Patients must be more than 18 years old
8)Written informed concent must be obtained from patients.
9)Parients must be positive for HLA-A2,A24,A26,A3,A11,A31 or A33
Key exclusion criteria
The following patients must be excluded.
1)Patients with sereve symptoms(active and severe infectious disease, circulatory disease, respiratory disease, kidney disease, immunodeficiency, disease of coagulation and so on.)
2)Patients with the past history of severe allergic reactions.
3)(Females) Patients who are during pregnancy, lactation expectant and desiring future fertility.
(Males) Patients do not accept contraception during the 1st vaccination to 70 days after last vaccination.
4)Patient who have 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.
5)Patients who are judged inappropriate for the clinical trial by doctors.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeru Yutani |
Organization
Kurume University
Division name
Cancer Vaccine Center
Zip code
Address
Kokubu-machi 155-1, Kurume, Fukuoka 839-0863
TEL
0942
yutani@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeru Yutani |
Organization
Kurume University
Division name
Cancer Vaccine Center
Zip code
Address
Kokubu-machi 155-1, Kurume, Fukuoka 839-0863
TEL
81-942-27-5210
Homepage URL
http://www.med.kurume-u.ac.jp/med/immun/F/
yutani@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University Cancer Vaccine Center
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
久留米大学医療センター（福岡県）
久留米大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 14 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 14 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 25 | Day |
Last modified on
| 2017 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014828
