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

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 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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name