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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000012696
Receipt No. 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

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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
Email 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/
Email yutani@med.kurume-u.ac.jp

Sponsor
Institute Kurume University Cancer Vaccine Center
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014828

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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