UMIN-CTR Clinical Trial

Public title

A phase two clinical trial of the personalized peptide vaccine for the recurrence prevention in pediatric cancer patients

Acronym

A phase two trial of peptide vaccine for the recurrence prevention in pediatric cancer patients

Scientific Title

A phase two clinical trial of the personalized peptide vaccine for the recurrence prevention in pediatric cancer patients

Scientific Title:Acronym

A phase two trial of peptide vaccine for the recurrence prevention in pediatric cancer patients

Region

Japan

Condition

Pediatric cancer patients

Classification by specialty

Hematology and clinical oncology	Pediatrics	Orthopedics
Neurosurgery	Child

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To testify the clinical effectiveness of personalized peptide vaccine for tumor recurrence prevention in pediatric cancer patients

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

the recurrence of the original tumor,judgement after six months from the beginning of the peptide vaccination

Key secondary outcomes

assessment of immune response by measurement of peptide specific IgG before and after peptide vaccination

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Vaccine

Interventions/Control_1

For the pediatric cancer patients who underlying diseases are controlled and hope for
recurrence prevention, we give selected four peptide vaccine once a month for six times.

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

4

years-old

<=

Age-upper limit

30

years-old

>

Gender

Male and Female

Key inclusion criteria

1) Pediatric cancer patients (children or adults who are diagnosed as having malignancy when they were under 15-year old)
2) Patients must be at a score level of 0-1 of performance status (PS).
3) Patients must be positive for HLA-A2,HLA-A24, HLA-26, HLA-A3,HLA-A11,HLA-A31,or HLA-A33 super types.
4) Patients must have IgG reactive to at least two of the candidate peptides restricted to the patients HLA types.
5) Patients must satisfy the following :
WBC >and= 2,500/mm3
Lymphocytes >and= 900/mm3
Hb >and= 8.0g/dl
platelets >and= 80,000/mm3
serum creatinine <and= 2xupper limit of normal
total bilirubin <and= 2x upper limit of normal
6) Patients must be between 4 and 30 year-old.
7) Patients must be expected to survive more than 3months.
8) Assent documents for 4-15 year-old patients and written informed consents for more than 16 year-old patients must be obtained.Moreover, informed consents are obtained from their caregivers.
9) Patients must be referred from cancer specialists.

Key exclusion criteria

The following patients must be excluded:
1) Patients with severe symptoms (active and severe infections, circulatory diseases, respiratory diseases, kidney diseases, immunodeficiency, disturbance of coagulation).
2) Active double cancer (synchronous double cancer and meta-chronous double cancer within three disease-free years), excluding carcinoma in situ (lesions equal to intra-epithelial or intra-mucosal cancer), judging to have been cured with local treatment.
3) Patients with the past history of severe allergic reactions.
4) Patients who hope for pregnancy
5) Patients who do not accept contraception from the 1st vaccination until 70 days after the last vaccination.
6) Patients who are judged inappropriate for entry to this trial by doctors.

Target sample size

50

Name of lead principal investigator

1st name
Middle name
Last name	Keiko Oda

Organization

Kurume University

Division name

Cancer vaccine center

Zip code

Address

#155-1,Kokubu-machi ,Kurume,Fukuoka, Japan, 839-0863

TEL

0942-27-5210

Email

oda_keiko@med.kurume-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Keiko Oda

Organization

Kurume University

Division name

Cancer vaccine center

Zip code

Address

#155-1,Kokubu-machi ,Kurume,Fukuoka, Japan, 839-0863

TEL

0942-27-5210

Homepage URL

Email

oda_keiko@med.kurume-u.ac.jp

Institute

Kurume University Cancer Vaccine Center

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

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

久留米大学がんワクチンセンター（福岡県）

Date of disclosure of the study information

2017

Year

12

Month

07

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

Terminated

Date of protocol fixation

2017

Year

12

Month

01

Day

Date of IRB

Anticipated trial start date

2018

Year

03

Month

11

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

12

Month

04

Day

Last modified on

2019

Year

01

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034543