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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023578
Receipt No. R000025028
Scientific Title Long-term maintenance of anti-tumor immune responses by vaccination with tri-WT1 peptide cancer vaccine WT1 Trio
Date of disclosure of the study information 2016/09/10
Last modified on 2018/06/09

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Basic information
Public title Long-term maintenance of anti-tumor immune responses by vaccination with tri-WT1 peptide cancer vaccine WT1 Trio
Acronym Long-term anti-tumor immune responses by WT1 Trio
Scientific Title Long-term maintenance of anti-tumor immune responses by vaccination with tri-WT1 peptide cancer vaccine WT1 Trio
Scientific Title:Acronym Long-term anti-tumor immune responses by WT1 Trio
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 Pneumology Hematology and clinical oncology
Gastrointestinal surgery Chest surgery Obsterics and gynecology
Dermatology Oto-rhino-laryngology Orthopedics
Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Assessment of long-term induction/maintenance of WT1 specific immune responses in patients treated with WT1 Trio cancer vaccine.
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Induction of WT1-specific immune responses assessed by WT1-related tests such as WT1-DTH skin reaction, serum levels of WT1 peptide IgG autoantibody, and frequency of WT1-CTL in PB
* This is evaluated at the interval ranging from 6 to 12 months.
Key secondary outcomes Safety
(Occurrence of SAE during the vaccination period)

Clinical efficacy
(Tumor regression during the vaccination period, OS, PFS)



Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
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 to four weeks. The interval can be changed within a range from one to 16 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 who was treated with WT1 peptide vaccine in the clinical trial of WT1 Trio Peptide-vaccine for Rare Cancers.
2 A patient in whom tumor growth was slowed or suppressed during the treatment with WT1 Trio vaccine in the clinical trial of WT1 Trio Peptide-vaccine for Rare Cancers.
3 A patient without severe dysfunctions in his/her vital organs
4 Age; 16-85 years-old.
5 ECOG Performance Status, PS :0-1. PS 2 is allowed in a case with primary brain tumor if it is ascribed to neural dysfunctions caused by brain tumor.
6 Written informed consent is obtained.
Key exclusion criteria 1 A patient with active infectious disease.
2 A patient who experienced SAE (grade >=4) in the previous clinical trial of WT1 peptide vaccine
3 A patient with severe complication or complications.
4 A patient with severe mental disorder.
5 A patient who participates in any other clinical trial
6 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 06-6879-3677
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 いいえ/NO

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 Enrolling by invitation
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=R000025028

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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