UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003696 |
|---|---|
| Receipt number | R000004475 |
| Scientific Title | Phase II study of Glypican-3(GPC3) peptide vaccine as treatment for clear cell adenocarcinoma of ovary. |
| Date of disclosure of the study information | 2010/06/10 |
| Last modified on | 2010/06/02 14:49:10 |
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Basic information
Public title
Phase II study of Glypican-3(GPC3) peptide vaccine as treatment for clear cell adenocarcinoma of ovary.
Acronym
A Phase II study of GPC3 peptide vaccine as treatment in the clear cell adenocarcinoma of ovary
Scientific Title
Phase II study of Glypican-3(GPC3) peptide vaccine as treatment for clear cell adenocarcinoma of ovary.
Scientific Title:Acronym
A Phase II study of GPC3 peptide vaccine as treatment in the clear cell adenocarcinoma of ovary
Region
| Japan |
Condition
Condition
clear cell carcinoma of ovary
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate efficacy and safety of GPC3 peptide vaccine in the treatment of clear cell adenocarcinoma of ovary
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
The one-year and two-year recurrence rate
Key secondary outcomes
Adverse effects of GPC3 vaccination.
GPC3-specific immune-responses to GPC3 vaccination
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
| Vaccine |
Interventions/Control_1
Injection of HLA-A24- or -A2-restricted GPC3 peptide (EYILSLEEL or FVGEFFTDV)
Emulsified with Montanide ISA51 adjuvant.
3 mg intradermally injection, every 2 weeks, 6 times, and every 2 months, 4 times, total 10 times in a year, until disease recurrence
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
Advanced ovarian clear cell carcinoma patient satisfying the following conditions,
1 Diagnosed as clear cell carcinoma of ovary
2 age 20 to 80 years old
3ECOG performance status of 0 to 1
4 HLA-A24 or A2
5Meet the following criteria for organ functions
WBC more than 3000/mm3
Hemoglobin more than 8.0g/dl
platelet more than 50000/mm3
serum bililnin less than 3.0mg/dl
serum AST/ALT less than 200U/l
serum creatinine less than 1.5mg/dl
6 survival period is expected to be more than 3 months
7Written informed consent has been obtained
8At least 4 weeks since last therapy for ovarin cancer
Key exclusion criteria
1 Uncontrolled pleural effusion or ascites
2 There are other malignancies.
3 Active infection excluding HBV,HCV
4 Positive for HIV
5clinically significant heart disease angina within the past six months, or uncontrolled Diabetes Mellitus
6There is severe psychiatric disorder
7Pregnant or lactaing woman,who are willing to be pregnant
8Past history of severe drug allergy
9Immunodeficiency, previous splenectomy,irradiation to the spleen
10Ongoing treatment with corticosteroid or immnosuppresant drug
11Previous allogrant transplantation
12 Responsible doctors juged the patient in appropriate for the trial
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumitaka Kikkawa |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
Address
Tsurumai-cho 65, Showa-ku, Nagoya
TEL
052-744-2261
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kiyosumi Shibata |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
Address
Tsurumai-cho 65, Showa-ku, Nagoya
TEL
052-744-2261
Homepage URL
shiba@med.nagoya-u.ac.jp
Sponsor or person
Institute
Section for Cancer Immunotherapy,
Investigative Treatment Division, Research Center for Innovative Oncology, National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Health, Labor and Welfare, Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
名古屋大学医学部付属病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 06 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 05 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 02 | Day |
Last modified on
| 2010 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004475
