UMIN-CTR Clinical Trial

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	Obsterics 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
Institute	Osaka university graduate school of medicine
Institute
Department

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
URL(English)	https://upload.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

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