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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023579
Receipt No. R000025008
Scientific Title WT1 Trio Peptide-vaccine for Rare Cancers
Date of disclosure of the study information 2016/09/10
Last modified on 2018/06/09

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Basic information
Public title WT1 Trio Peptide-vaccine for Rare Cancers
Acronym WT1 Trio Peptide-vaccine for Rare Cancers
Scientific Title WT1 Trio Peptide-vaccine for Rare Cancers
Scientific Title:Acronym WT1 Trio Peptide-vaccine for Rare Cancers
Region
Japan

Condition
Condition Thymic cancer
Thymoma
Soft tissue sarcoma
Malignant glioma
Salivary gland cancer
Head and neck mucoepidermoid carcinoma
Olfactory neuroblastoma
Head and neck mucosal malignant melanoma
Ophthalmic malignant melanoma
Cancer of the external auditory canal
Testicular cancer
Cancer of penis
Adrenal cancer
Malignant mesothelioma
Cancer of the small intestine
Merkel cell carcinoma
Cutaneous lymphoma
(Rare cancers listed above)
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Chest surgery Endocrine surgery Obsterics and gynecology
Dermatology Oto-rhino-laryngology Orthopedics
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Induction of more robust WT1-specific immune responses by vaccination with three WT1 peptides (WT1 Trio) than that induced by vaccination with single WT1 CTL peptide
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Induction of WT1-specific immune responses assessed by WT1-related tests such as WT1-DTH skin reaction and serum levels of WT1 peptide IgG autoantibody at 1M, 2M, and 3M of WT1 Trio vaccine.
Key secondary outcomes Safety
(Occurrence of SAE during the vaccination period)
Clinical efficacy
(Tumor regression at 1M, 2M, and 3M of WT1 Trio vaccine, OS, PFS)
Induction of immune responses
(Frequency of WT1-CTLs in PB)


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 A patient is vaccinated with Montanide ISA51-adjuvanted WT1 Trio cancer vaccine consisting of two WT1 CTL peptides (WT1-126 and WT1-235) and one WT1 HTL peptide (WT1-332) (2mg each) seven times at the interval of two weeks.
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
16 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria 1 A patient with a malignancy below that is diagnosed histologically.
Thymic cancer, Stage III, IV
Thymoma, Stage III, IV
Soft tissue sarcoma, recurrent or advanced
Malignant glioma, recurrent or advanced
salivary gland cancer, recurrent or advanced
Head and neck mucoepidermoid carcinoma, recurrent or advanced
Olfactory neuroblastoma, recurrent or advanced
Head and neck mucosal malignant melanoma, recurrent or advanced
Ophthalmic malignant melanoma, recurrent or advanced
Cancer of the external auditory canal, recurrent or advanced
testicular cancer, recurrent or advanced, and refractory, or treatment intolerant
cancer of penis, recurrent or advanced
adrenal cancer, recurrent or advanced
malignant mesothelioma, recurrent or advanced
cancer of the small intestine, recurrent or advanced, and refractory, or treatment intolerant
Merkel cell carcinoma, recurrent or advanced
Cutaneous lymphoma, recurrent or advanced
2 A patient with an advanced or refractory disease or who rejected a standard therapy
3 WT1 expression in the tumor as determined by immunohistochemistry
4 A patient with HLA-A-24:02 or HLA-A-02:01
5 A patient with measurable tumor or tumors
6 A patient without progressive metastatic brain tumors. * This should be confirmed by CT or MRI imaging.
7 Age; 16-85 years-old.
8 ECOG Performance Status, PS :0-1. PS 2 is allowed in case with primary brain tumor if it is ascribed to neural dysfunctions caused by brain tumor.
9 A patient without severe dysfunctions in his/her vital organs
10 A patient without uncontrolled pleural effusion, ascites, or cardiac effusion
11 Life longer than 6 months is expected.
12 Written informed consent is obtained.
Key exclusion criteria 1 A patient with active infectious disease.
2 A patient with severe complication or complications.
3 A patient with severe mental disorder.
4 A patient who participates in any other clinical trial
5 A patient who should not be recruited to the clinical trial as determined by the investigators
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yusuke OJI
Organization Osaka University Graduate School of Medicine
Division name Dept. Cancer Stem Cell Biology
Zip code
Address 1-7 Yamada-oka Suita Osaka, Japan
TEL 06-6879-2597
Email oji@sahs.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yusuke Oji
Organization Osaka University Graduate School of Medicine
Division name Dept. Cancer Immunotherapy
Zip code
Address 2-2 Yamada-oka Suita Osaka, Japan
TEL 06-6879-3676
Homepage URL http://sahswww.med.osaka-u.ac.jp/~hmtonc/vaccine/
Email clinical-trial@cit.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine
Dept. Cancer Immunotherapy
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) Ministry of science and technology

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 大阪大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2016 Year 09 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
2016 Year 08 Month 08 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 01 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
2016 Year 08 Month 10 Day
Last modified on
2018 Year 06 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025008

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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