UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025452
Receipt number R000029240
Scientific Title Phase I clinical study of a WT1-W10 peptide immunotherapy combined with standard treatment against diffuse midline glioma (WT1-TR-DMG).
Date of disclosure of the study information 2017/01/04
Last modified on 2019/07/01 11:32:11

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Basic information

Public title

Phase I clinical study of a WT1-W10 peptide immunotherapy combined with standard treatment against diffuse midline glioma (WT1-TR-DMG).

Acronym

WT1-W10 immunotherapy against DMG (WT1-TR-DMG)

Scientific Title

Phase I clinical study of a WT1-W10 peptide immunotherapy combined with standard treatment against diffuse midline glioma (WT1-TR-DMG).

Scientific Title:Acronym

WT1-W10 immunotherapy against DMG (WT1-TR-DMG)

Region

Japan


Condition

Condition

glioblastoma multiforme

Classification by specialty

Pediatrics Neurosurgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

This study aims at evaluating the safety of an immunotherapy using WT1-W10 peptide combined with the standard radio-chemotherapy using temozolomide against juvenile diffuse midline glioma. An addition of bevacizumab is permissible, but evaluation will be made separately. As an auxiliary subject of observation includes optimization of dose of the immunogen.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase I


Assessment

Primary outcomes

Degree and frequency of adverse events (> grade 3)

Key secondary outcomes



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 Vaccine

Interventions/Control_1

Standard radio-chemotherapy using wither 1) or 2) below will be combined.

1)Temozolomide (TMZ) + WT1-W10 peptide
2)Temozolomide (TMZ) + bevacizumab (BV) + WT1-W10 peptide

1.WT1-W10 peptide immunotherapy
3.0 mg WT1-W10 peptide in 300micro-l of 5% glucose is mixed with the inactivated 5x108 Bordetella pertussis whole cell vaccine in 100micro-l saline and injected intra-dermally into 4 sites (100micro-l per site) near the sub-clavicular and axial lymph nodes. Immunization is repeated every week. If the erythema which usually emerge 24-48 hours after the immunization, exceed 5 cm in diameter dose of the immunogen will be reduced to 1/2 from the next injection.

2.Temozolomide
By following the standard protocol provided by the manufacturer 75 mg/m2 of TMZ was ingested every day for 5 days a week and for 6 weeks. After 4 weeks of withdrawal, 150 (up to 200) mg/m2 of TMZ was taken every day for 5 days followed by 3 week-withdrawal. This 28-day interval of TMZ administration is repeated.

3.Bevacizumab
5 mg/Kg/week of BV was administered intravenously every 2-3 weeks. Synchronization with the schedule of TMZ is not necessary.

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

3 years-old <=

Age-upper limit

18 years-old >

Gender

Male and Female

Key inclusion criteria

1)Diagnosed as diffuse midline glioma (DMG) and competent to receive standard radio-chemotherapy using TMZ. A further inclusion of BV is permissive.
2)3 - 17 years of age
3)Carrying one or two of HLA-A*24:02, A*02:01, A*02:06, A*02:07 genes
4)The tumor overexpresses WT1 protein (optional for the cases where tumor tissue has been obtained)
5)Karnofsky Index > 60% or performance status : 0-2
6)Expected survival > 3 months
7)No serious impairment of the heart, lung, liver, kidney and bone marrow
8)Without serious diseases aside from DMG, no double cancers including malignancies of the hematopoietic organs
9)Written consent from the parents and/or patient is obtained.

Key exclusion criteria

One or more of the following criteria leads to exclusion of the subject.
1)Uncontrollable infections, including active tuberculosis
2)Severe comorbidities (e.g. malignant hypertension, severe congestive heart disease, severe ischemic heart disease, myocardial infarction within 3 months, end-stage liver insufficiency, uncontrollable diabetes mellitus, severe pneumonitis etc.)
3)After the bone marrow implantation
4)Severe psychological disorders
5)Being enrolled in other clinical trials
6)Once enrolled in this study, but was disqualified for some reasons (Double enrollment is prohibited.)
7)Disqualified by the doctors due to some medical, psychological and/or social problems

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mikiya Fujieda

Organization

Kochi Medical School

Division name

Department of Pediatrics

Zip code


Address

Kohasu, Okocho, Nankoku, Kochi, 783-8505, Japan

TEL

088-866-5811

Email

fujiedam@kochi-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yu Kawanishi

Organization

Kochi Medical School

Division name

Department of Pedicatrics

Zip code


Address

Kohasu, Okocho, Nankoku, Kochi, 783-8505, Japan

TEL

088-880-2355

Homepage URL


Email

vaccine@kochi-u.ac.jp


Sponsor or person

Institute

Cancer Vaccination Therapy Research Network Central Office, Department of Immunology, Kochi Medical School

Institute

Department

Personal name



Funding Source

Organization

NEC Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


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

2017 Year 01 Month 04 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 12 Month 28 Day

Date of IRB

2017 Year 01 Month 05 Day

Anticipated trial start date

2017 Year 01 Month 05 Day

Last follow-up date

2021 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 12 Month 28 Day

Last modified on

2019 Year 07 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029240


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name