UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013257
Receipt number R000015466
Scientific Title Phase I clinical trial of WT1 peptide-based vaccine combined with Temozoromide for pediatric patients with malignant glioma.
Date of disclosure of the study information 2014/02/26
Last modified on 2014/02/25 11:48:27

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Basic information

Public title

Phase I clinical trial of WT1 peptide-based vaccine combined with Temozoromide for pediatric patients with malignant glioma.

Acronym

Phase I clinical trial of WT1 peptide-based vaccine combined with Temozoromide for pediatric patients with malignant glioma

Scientific Title

Phase I clinical trial of WT1 peptide-based vaccine combined with Temozoromide for pediatric patients with malignant glioma.

Scientific Title:Acronym

Phase I clinical trial of WT1 peptide-based vaccine combined with Temozoromide for pediatric patients with malignant glioma

Region

Japan


Condition

Condition

High grade glioma, Diffuse intrinsic pontine glioma

Classification by specialty

Pediatrics Neurosurgery

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

Safty

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase



Assessment

Primary outcomes

Safty

Key secondary outcomes

progression free survival time
all over survival time
Immunomonitering


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

The patient is intradermally injected with 0.5-2.0 mg of the HLA-A*2402-restricted, 9-mer modified WT1 peptide (p235-243:CYTWNQMN), HLA-A*0201-restricted, 9-mer modified WT1 peptide (p235-243:CYTWNQMN) and 0.5-2.0 mg of 16-mer WT1 helper peptide (p332-347:KRYFKLSHLQMHSRKH) emulsified with Montanide ISA51 adjuvant.
The WT1 vaccination was scheduled to be performed 5 times at bi-weekly intervals. The safety are evaluated by the NCI-CTC criteria from 1 to 2 weeks after 5th WT1 vaccination.

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


Not applicable

Age-upper limit

16 years-old >

Gender

Male and Female

Key inclusion criteria

1. Diagnosed as malignant glioma or diffuse intrinsic glioma
2. Performance status (ECOG) 0-3
3. Meet the following criteria for organ functions
Neutrophil more than 1,000/microliter, Platelet more than 25,000/microliter, Hemoglobin more than 6.5 g/dl
Serum creatinine less than 2.0 mg/dL
Serum bilirubin less than 3 folds of the upper normal limit
Serum AST/GOT less than 3 folds of the upper normal limit
Serum Albumin more than 2.5g/dl
Arterial oxygen saturation more than 94% in room air
4. Informed consent has been obtained from legal guardian.
5. HLA 2402 and or 0201
6. WT1 expression in malignant cells in high grade glioma

Key exclusion criteria

1. There is deep-seated active infection.
2. There are severe complications including malignant hypertention, cardiac failure, liver cirrhosis, severe DM, severe lung fiblosis, active interstitial pneumonitis.
3. Patients who have complications that are considered inappropriate for the trial.
4. There are other malignancies.
5. There are hematopoietic stem cell disorders such as MDS.
6. Post allogeneic hematopoietic stem cell transplantation
7. Responsible doctors judged the patient inappropriate for the trial

Target sample size

18


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshiko Hashii

Organization

Osaka University Graduate School of Medicine

Division name

Pediatrics

Zip code


Address

2-2, Yamada-oka, Suita City, Osaka , Japan

TEL

06-6879-3932

Email

areken@ped.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoshiko Hashii

Organization

Osaka University Graduate School of Medicine

Division name

Pediatrics

Zip code


Address

2-2, Yamada-oka, Suita-city, Osaka, Japan

TEL

06-6879-3932

Homepage URL


Email

areken@ped.med.osaka-u.ac.jp


Sponsor or person

Institute

Osaka University Graduate School of Medicine Pediatrics

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



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

2014 Year 02 Month 26 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

Preinitiation

Date of protocol fixation

2014 Year 02 Month 26 Day

Date of IRB


Anticipated trial start date

2014 Year 07 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

2014 Year 02 Month 25 Day

Last modified on

2014 Year 02 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015466


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name