UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003903 |
|---|---|
| Receipt number | R000004695 |
| Scientific Title | Tumor specific vaccination therapy for advanced/recurrent cervical cancer using HLA-A*0201 restricted Specific Epitope Peptides Cocktail derived from Tumor genom/Tumor related Angiogenetic factors genom |
| Date of disclosure of the study information | 2010/07/12 |
| Last modified on | 2015/07/13 08:45:59 |
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Basic information
Public title
Tumor specific vaccination therapy for advanced/recurrent cervical cancer using HLA-A*0201 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*0201 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
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elcidate the feasibility and efficacy of HLA-A*0201 restricted Specific Epitope Peptides Cocktail of HIG2(hypoxia-inducible protein 2) and VEGFR(vaacular endotherial growth factor receptor)-1 and VEGFR2.
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
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| 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 including standard chemotherapy/chemoradiotherapy for CC, 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-A*0201 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 ofObstetrics and Gynecology
Division name
gynecologic oncology
Zip code
Address
19-1Uchimaru Morioka, Iwate, Japan0208505
TEL
81-19-651-5111
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
s-take-imugo@zeus.eonet.ne.jp
Sponsor or person
Institute
Iwate Medical University School of Medicine department of Obastetrics and Gynecology
Institute
Department
Personal name
Funding Source
Organization
Iwate Medical University School of Medicine departemtet of Obsteterics and Gynecology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
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付属病院（岩手県）Iwate Medical University Hospital(Iwate Prefecture)
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 07 | Month | 12 | 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
| 2014 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 07 | Month | 12 | Day |
Last modified on
| 2015 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004695
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