UMIN-CTR Clinical Trial

Public title

Phase I clinical trial of pan-HLA type personalized peptide vaccine for advanced pediatric malignant glioma patients

Acronym

Pan-HLA type personalized peptide vaccine trial for pediatric malignant glioma patients

Scientific Title

Phase I clinical trial of pan-HLA type personalized peptide vaccine for advanced pediatric malignant glioma patients

Scientific Title:Acronym

Pan-HLA type personalized peptide vaccine trial for pediatric malignant glioma patients

Region

Japan

Condition

Advanced pediatric malignant glioma patients who are refractory to standard therapies

Classification by specialty

Pediatrics

Neurosurgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The aim of the study is to investigate adverse events (evaluation of safety) of pan-HLA type personalized peptide vaccine which applicable for almost all of cancer patients in Japanese and majority in the world. Pediatric patients(more 3 year-old and less 16 year-old), who are refractory to standard therapies for malignant glioma, will be enrolled. Peptides (maximum 4) among 24 (each 8 for HLA-A2, -A24, and -A3 super type) peptides, which were identified as vaccine candidates for cancer patients, are administered subcutaneously. Vaccine peptide selection for each patient will be performed according to the reactivity of pre-vaccination plasma IgG to the candidate peptides.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I

Primary outcomes

Adverse events of peptide vaccine are evaluated based on the CTCAE v3.0 (JCOG version).

Key secondary outcomes

Evaluation of immunological responses (cytotoxic T-lymphocytes , anti-peptide IgG) before and after 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

Vaccine

Interventions/Control_1

Peptides (maximum 4) among 24 (each 8 for HLA-A2, -A24, and -A3 super type) peptides, which were identified as vaccine candidates for cancer patients, are administered with Freund incomplete adjuvant. Vaccine peptide selection for each patient will be performed according to the reactivity of pre-vaccination plasma IgG to the candidate peptides.
Each emulsified peptide (1 or 2 mg/peptide) are separately injected into subcutaneous once a week for 6-weeks (total 6 times). Brain CT/MRI, and blood samples for hematology and biochemistry are taken at beginning and 1-week after the 6th 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

Age-lower limit

3

years-old

<=

Age-upper limit

20

years-old

>

Gender

Male and Female

Key inclusion criteria

The subjects must satisfy the following conditions.
1) Patients must be clinically diagnosed as malignant glioma, and are refractory to standard therapies such as radiotherapy or radiochemotherapy.
2) Patients must be more 3 year-old and less 16 year-old.
3) Patients must be positive for HLA-A2, -A3, -A11, -A24, -A31, or -A33.
4) Patients must have significant level of plasma IgG reactive to at least one of the vaccine candidate peptides.
5) The vaccine therapy must be started more than 4 weeks after the last chemotherapy.
6) Patients must be expected to survive more than 3 months.
7) Patients must satisfy the followings:
WBC more than 3,000/mm3
Lymphocytes more than 1,000/mm3
Hb more than 10.0g/dl
Platelet more than 100,000/mm3
Serum Creatinine less than 1.5 times of the standard value
Total Bilirubin less than 1.5 times of the standard value
ALT less than 2.5 times of the standard value
AST less than 2.5 times of the standard value
9) Written informed consent must be obtained from patients and legally acceptable representatives.
10) Patients must be negative for Hepatitis virus B/C.

Key exclusion criteria

The following patients must be excluded:
1) Patients with cerebral or cerebellar grade I or II glioma. 2) Patients with severe symptoms (circulatory disease, respiratory disease, kidney disease, immunodeficiency, disturbance of coagulation etc).
3) Patients with the past history of severe allergic reactions.
4) Patients with active infectious disease
5) Pregnant, nursing, or who wants pregnancy. Patients with no acceptance of use effective contraception during and for at least 70 days after study participation.
6) Patients who are judged inappropriate for the clinical trial by doctors.

Target sample size

10

Name of lead principal investigator

1st name
Middle name
Last name	Minoru Shigemori

Organization

Kurume University School of Medicine

Division name

Department of Neurosurgery

Zip code

Address

Asahi-machi 67, Kurume,Fukuoka 830-0011, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name	Akira Yamada

Organization

Kurume University

Division name

Research Center for Innovative Cancer Therapy, Cancer Vaccine Department Division

Zip code

Address

TEL

0942-31-7744

Homepage URL

http://www.med.kurume-u.ac.jp/med/sentanca/examine.html

Email

akiynd@med.kurume-u.ac.jp

Institute

Department of Immunology, Kurume University School of Medicine

Institute

Department

Personal name

Organization

The Ministry of Education, Culture, Sports, Science, and Technology, Japan

Organization

Division

Category of Funding Organization

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

Date of disclosure of the study information

2007

Year

07

Month

03

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

2007

Year

04

Month

16

Day

Date of IRB

Anticipated trial start date

2007

Year

06

Month

01

Day

Last follow-up date

2010

Year

12

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2007

Year

07

Month

03

Day

Last modified on

2011

Year

09

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000855