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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

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 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


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

Value
https://center6.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