UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011859
Receipt number R000013862
Scientific Title A phase II study of maintenance therapy with WT1 peptide-based cancer vaccine following the first-line therapy for advanced-stage ovarian cancer
Date of disclosure of the study information 2013/10/01
Last modified on 2018/10/07 11:51:35

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Basic information

Public title

A phase II study of maintenance therapy with WT1 peptide-based cancer vaccine following the first-line therapy for advanced-stage ovarian cancer

Acronym

WT1Ov

Scientific Title

A phase II study of maintenance therapy with WT1 peptide-based cancer vaccine following the first-line therapy for advanced-stage ovarian cancer

Scientific Title:Acronym

WT1Ov

Region

Japan


Condition

Condition

Ovarian cancer

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the efficacy of WT1 peptide-based cancer vaccine as the maitenance tharapy following surgical and chemotherapy for the patients with advanced-stage ovarian cancer

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

2-year disease free survival rate

Key secondary outcomes

overall survival, antigen-specific immunity, safety, and so on


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

Interventions/Control_1

WT1 peptide-based cancer vaccine is contained 3 kinds of WT1 peptides (np 126: 2.0mg, mp235: 2.0mg, and np332: 2.0mg) and Montanide ISA51 adjuvant.
Intradermally injection of WT1 vaccine will be continued for 1 year, in total 17 times vaccinations will be done.
from day1 to day85: biweekly (in total 7 times)
from 86 to day365: monthly (in total 10 times)
If a patinet request to receive WT1 vaccine continuously afer completion, WT1 vaccine may be administrated at 8-weeks interval for 1 year.

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

79 years-old >=

Gender

Female

Key inclusion criteria

1) Pathologically confirmed ovarian cancer
2) FIGO stage III or IV
3) Received Taxane + Platinum based chemotherapy as neo-adjuvant and/or Adjuvant chemotherapy
4) Complete remission confirmed with radiological evaluations
5) From 28 to 55 days after completion of surgical + chemotherapy
6) ECOG-PS: 0 - 1
7) Age: 20 - 79 years old
8) HLA-A*24:02 and / or HLA-A*02:01
9) no previous history of treatment for other cancers within at least 5 years
10) adequate organ functions
Neutrophils > 1,200
Platelets > 75, 000
Hb > 8.5
sCr < 2.0mg/dl
T-Bil < 2.0mg/dl
AST / ALT < 100 IU/L
11) Informed consent

Key exclusion criteria

1) Residual diseases after surgical and chemotherapy
2) Received intra-peritoneum chemotherapy
3) Active other cancers except for carcinoma in situ treated completely
4) Received Immunosuppresive agents actively at registration
5) Received Growth factor, including G-CSF, Epo, TPO, within 14 days before registration
6) Received other tested agents within 28 days before registration
7) Received WT1 vaccine
8) Past history of Myeloproliferative diseases, MSD
9) Past history of pulmonary fibrosis, interstitial pneumonitis
10) Past history of autoimmune diseases, including collagen diseases
11) Severe Complications, including Heart failure, Renal faiure, Hapatic failure, ileus, uncontrolable DM, and so on
12) active infectious diseases
13) Past history of HIV, HBV, and HCV infections
14) Grade 3 or severer Neutopatic complications
15) Hypersensitivity to some drugs
16) Pregnancy / lactation
17) Severe Psychological Problems
18) Other severe problems unsuitable for this study

Target sample size

55


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Haruo Sugiyama

Organization

Osaka university graduate school of medicine

Division name

Functional diagnostic science

Zip code


Address

2-2, Yamada-oka, Suita-city, Osaka, Japan

TEL

06-6879-2593

Email

sugiyama@sahs.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Sumiyuki Nishida

Organization

Osaka university graduate school of medicine

Division name

Cancer Immunotherapy

Zip code


Address

2-2, Yamada-oka, Suita-city, Osaka, Japan

TEL

06-6879-3676

Homepage URL


Email

clinical-trial@cit.med.osaka-u.ac.jp


Sponsor or person

Institute

Osaka university graduate school of medicine

Institute

Department

Personal name



Funding Source

Organization

the Japanese Ministries of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



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



Other administrative information

Date of disclosure of the study information

2013 Year 10 Month 01 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

2013 Year 09 Month 18 Day

Date of IRB


Anticipated trial start date

2013 Year 10 Month 08 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 09 Month 25 Day

Last modified on

2018 Year 10 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013862


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name