UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023579 |
|---|---|
| Receipt number | R000025008 |
| Scientific Title | WT1 Trio Peptide-vaccine for Rare Cancers |
| Date of disclosure of the study information | 2016/09/10 |
| Last modified on | 2024/03/11 18:58:36 |
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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 | Obstetrics 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
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/
clinical-trial@cit.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Dept. Cancer Immunotherapy
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2016 | Year | 08 | Month | 08 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 10 | Day |
Last modified on
| 2024 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025008
