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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003902
Receipt No. R000004694
Scientific Title Tumor specific vaccination therapy for advanced/recurrent cervical cancer using HLA-A*2402 restricted Specific Epitope Peptides Cocktail derived from Tumor genom/Tumor related Angiogenetic factors genom
Date of disclosure of the study information 2010/07/11
Last modified on 2015/01/12

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Basic information
Public title Tumor specific vaccination therapy for advanced/recurrent cervical cancer using HLA-A*2402 restricted Specific Epitope Peptides Cocktail derived from Tumor genom/Tumor related Angiogenetic factors genom
Acronym Therapeutic vaccination therapy for cervical cancer
Scientific Title Tumor specific vaccination therapy for advanced/recurrent cervical cancer using HLA-A*2402 restricted Specific Epitope Peptides Cocktail derived from Tumor genom/Tumor related Angiogenetic factors genom
Scientific Title:Acronym Therapeutic vaccination therapy for cervical cancer
Region
Japan

Condition
Condition advanced/recurrent cervical cancer with the conditions of unremoval by surgery, or refractory, chemo-resistant disease.
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To elcidate the feasibility and efficacy of HLA-A*2402 restricted Specific Epitope Peptides Cocktail of FOXM1,MELK,and HJURP.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Safety and Overall survival
Key secondary outcomes time to progression, evaluation of QOL, immunological evaluation, response rate

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 peptides Vaccine
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
80 years-old >=
Gender Female
Key inclusion criteria 1.Unresectable advanced/recurrent cervical cancer(CC) patient with prior chemotherapy/chemo-radiotherapy including standard chemotherapy for cervical cancer, and who are identified as chemoresistent and/or further chemotherapy would not continue due to their adverse events (AEs) is eligible.
2. Performance Status (PS) 0-2
3. Age:20-80 years old, in principle
4. patients with measurable/detectable disease using CT/MRI would be favorable(The existence of targeted lesion using RECIST version 1.01 would be more favorble)
5.The treatment interval from the latest prior therapy must be more than 28days.
6. Prospective survival would be 3months or over.
7. Organ functions (stated bellow) must be reserved: bone marrow function (WBC conts:2000-1,0000/mm3, Platelet: over 50,000/mm3,GOT(AST) and GPT(ALT): less than </=150IU/L, T-Bil:</=3.0mg/dL, Crn</=3.0mg/dL
8.HLA-A2402 is positive
9. written informed consent is necessary
Key exclusion criteria 1. pregnant women
2. breast feeding mothor(stop brest feeding)
3.women who are willing to be pregnant(must perform contraception)
4.complication of uncontrolable infection
5.Usage of continual systemic steroid and immuno-suppressant is prohibited during treatment.
6. Who are recognized ineligible by the resiponsible investigator or investigators
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toru Sugiyama
Organization Iwate Medical University School of Medicine Department of Obstetrics and Gynecology
Division name gynecologic oncology
Zip code
Address 19-1Uchimaru Morioka, Iwate, Japan0208505
TEL 81-19-651-5111
Email sugiyama@iwate-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Takeuchi
Organization Iwate Medical University School of Medicine Department of obstetrics and gynecology
Division name Gynecologic Oncology
Zip code
Address 19-1 Uchimaru Morioka, Iwate, Japan0208505
TEL 81-19-651-5111
Homepage URL
Email s-take-imugo@zeus.eonet.ne.jp

Sponsor
Institute Iwate Medical University School of Medicine department of Obstetrics and Gynecology
Institute
Department

Funding Source
Organization Iwate Medical University School of Medicine
department of obstetrics and gynecology
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Human Genome Center Institute of Medical Science, University of Tokyo
Name of secondary funder(s) Grant of Ministry of education,culture,sport and technology

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 岩手医科大学医学部附属病院 (岩手県)(Iwate Medical University Hospital: Iwate Morioka)

Other administrative information
Date of disclosure of the study information
2010 Year 07 Month 11 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
2010 Year 05 Month 25 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 01 Day
Last follow-up date
2014 Year 10 Month 30 Day
Date of closure to data entry
2014 Year 10 Month 30 Day
Date trial data considered complete
2014 Year 12 Month 31 Day
Date analysis concluded
2014 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2010 Year 07 Month 11 Day
Last modified on
2015 Year 01 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004694

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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