UMIN-CTR Clinical Trial

Public title

Phase I clinical trial of WT1 peptide vaccine therapy for pediatric cancers

Acronym

Phase I clinical trial of WT1 peptide vaccine therapy for pediatric cancers

Scientific Title

Phase I clinical trial of WT1 peptide vaccine therapy for pediatric cancers

Scientific Title:Acronym

Phase I clinical trial of WT1 peptide vaccine therapy for pediatric cancers

Region

Japan

Condition

Pediatric cancers

Classification by specialty

Pediatrics

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To assess the safety and feasibility of WT1 peptide vaccination with adjuvant OK-432

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase I

Primary outcomes

Safety (Ratios of adverse events)

Key secondary outcomes

Overall survival, The ratio of the patients who completed the course, WT1 specific CTL rate in peripheral blood mononuclear cells (PBMCs), Lymphocyte subsets, WT1-specific interferon-gamma production of PBMCs

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Vaccine

Interventions/Control_1

Seven doses of HLA-A*24- or A*02-restricted WT1 peptide (1-3mg) emulsified with 0.5-2KE of adjuvant will be intradermally injected on bilateral axillary and inguinal areas every 2 weeks. WT1 peptide dose will be adjusted according to patient's body weight (1mg of WT1 peptide for body weight (BW) <10kg, 2mg for 10kg < BW <20kg, 3mg for BW >30kg). Injection schedule can be changed within 3 days.

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

Age-lower limit

Not applicable

Age-upper limit

20

months-old

>

Gender

Male and Female

Key inclusion criteria

1. Patients with pathologically proven pediatric cancers.
2. Patients treated with operation, chemotherapy, and radiotherapy accoding to standard clinical guidelines.
3. Patients who did not received any specific immunotherapy before enrollement of this trial.
4. Patients with HLA-A*02 or A*24 and having neither allergies to OK-432 nor to penicillin.
5. Patients aged 19 years or under at the time of informed concent.
6. Karnofsky performance status (KPS) are over 60%.
7. Estimated survival duration is over 3 months.
8. Function of major organs is maintained, with the following inclusion criteria.
A) Leukocyte count>=3,000/mm3
B) Lymphocyte count>=500/ mm3
C) Platelet count>=100,000/mm3
D) Hemoglobin concentration >=10.0g/dL
E) AST/ALT <2.5 x ULN
F) Serum creatinine <=1.5 x ULN
G) APTT/PT-INR <=1.5 x ULN

Key exclusion criteria

1. Patients with severe organ dysfunction, infection under treatment, blood abonormalities or bleeding tendency.
2. Patients with leukemia or lymphoma are excluded.

Target sample size

15

Name of lead principal investigator

1st name
Middle name
Last name	Shigetaka Shimodaira

Organization

Shinshu University Hospital

Division name

Center for Advanced Cellular Therapy

Zip code

Address

Asahi 3-1-1 Matsumoto city, 390-8621, Japan

TEL

0263-37-3220

Email

shimodai@shinshu-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Shigetaka Shimodaira

Organization

Center for Advanced Cellular Therapy

Division name

Clinical Trial Research Center

Zip code

Address

Asahi 3-1-1 Matsumoto city, 390-8621, Japan

TEL

0263-37-3220

Homepage URL

Email

shimodai@shinshu-u.ac.jp

Institute

Shinshu University

Institute

Department

Personal name

Organization

Shinshu University Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

Division of Dendritic Cell therapy, Matsumoto Dental University Hospital

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

07

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2013

Year

06

Month

30

Day

Date of IRB

2013

Year

06

Month

30

Day

Anticipated trial start date

2013

Year

07

Month

01

Day

Last follow-up date

2017

Year

06

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

06

Month

24

Day

Last modified on

2023

Year

12

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012638