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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003696
Receipt No. 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

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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
Obsterics 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
Email

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
Email shiba@med.nagoya-u.ac.jp

Sponsor
Institute Section for Cancer Immunotherapy,
Investigative Treatment Division, Research Center for Innovative Oncology, National Cancer Center Hospital East
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004475

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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