UMIN-CTR Clinical Trial

Public title

Phase II clinical trial of personalized peptide vaccination for malignant brain tumor patients

Acronym

Peptide vaccination for malignant brain tumor patients

Scientific Title

Phase II clinical trial of personalized peptide vaccination for malignant brain tumor patients

Scientific Title:Acronym

Peptide vaccination for malignant brain tumor patients

Region

Japan

Condition

malignant brain tumor

Classification by specialty

Neurosurgery

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

Up to 4 from the 31 candidate peptides, to which peptide specific IgG are detected before vaccination,are administered to malignant brain tumor patients. The aim of the study is to investigate immune response and also analyze a relationship between the immune response and overall survival.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Evaluation of immune responses (anti-peptide IgG) before and after personalized peptide vaccination.

Key secondary outcomes

1. Evaluation of long-term prognosis (progression free survival and overall survival).

2. Adverse events of peptide vaccination. Adverse events are evaluated by the NCI-CTCAE.

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

Medicine

Vaccine

Interventions/Control_1

<1st treatment: total 8 times, which include weekly injection for 4 times followed by bi-weekly injection for 4 times>

Select vaccine peptides (up to 4) from 31 candidate peptides , to which peptide-specific IgGs are detected before vaccination. Individually emulsify these peptides with IFA and subcutaneously inject (3.0 mg/peptide).

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

16

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

The subjects must be satisfactory the following conditions.

1) patients must be diagnosed as grade III or IV malignant brain tumor. Presence of target legion, former treatment, and disease stage are not considered.

2) patients must be at a score level 0-1 of ECOG performance status.

3) patients must have IgGs reactive to at least two of candidate peptides belongs to an apropriate group(s) for patient's HLA types.

4) patients must be expected to survive more than 3 months.

5) Patients must satisfy the followings.
WBC is more than 2500 per mm3
Lymphocyte is more than 1000 per mm3
Hb is more than 8 g per dL
Platelet is more than 50000 per mm3
Serum creatinine is less than 2.0 mg per dL
Total bilirubin is less than 2.5 mg per dL

6) patients must be more than 16 year old.

7) written informed consent must be obtained from patients (if the patient is under 20 years old, indivisual and legal gurdian).

8) patients must be positive for HLA-A2, A24, A26, A3, A11, A31 or A33.

Key exclusion criteria

The following patients must be excluded.

1) Patients with severe symptoms (active and severe infectious disease, circulatory disease, respiratory disease, kidney disease, immunodeficiency, disturbance of coagulation).

2) Patients with the past history of severe allergic reactions.

3)(Females) Patients who are during pregnancy, lactation expectant, and desiring future fertility.
(Males) Patients do not accept contraception during the 1st vaccination to 70 days after the last vaccination.

4) Patients who are judged inappropriate for the clinical trial by doctors.

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Mizuhiko Terasaki

Organization

Kurume University

Division name

Neurosurgery

Zip code

Address

Asahi-machi 67, Kurume, Fukuoka 830-0011

TEL

0942-31-7570

Email

jintara@med.kurume-u.ac.jp

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 Development Division

Zip code

Address

Asahi-machi 67, Kurume, Fukuoka 830-0011

TEL

0942-31-7744

Homepage URL

Email

akiymd@med.kurume-u.ac.jp

Institute

Kurume University Cancer Vaccine Center

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Other

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

2009

Year

12

Month

16

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

2009

Year

11

Month

19

Day

Date of IRB

2009

Year

11

Month

19

Day

Anticipated trial start date

2009

Year

12

Month

01

Day

Last follow-up date

2014

Year

11

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2009

Year

12

Month

16

Day

Last modified on

2019

Year

12

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003468