UMIN-CTR Clinical Trial

Public title

Phase II clinical trial of personalized peptide vaccination for standard therapy failure patients with malignant glioma (glioblastoma)

Acronym

Personalized peptide vaccination for patients with glioblastoma

Scientific Title

Phase II clinical trial of personalized peptide vaccination for standard therapy failure patients with malignant glioma (glioblastoma)

Scientific Title:Acronym

Personalized peptide vaccination for patients with glioblastoma

Region

Japan

Condition

malignant glioma (glioblastoma)

Classification by specialty

Neurosurgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate clinical effects and safety of the peptide vaccine, peptides (maximum 4) among 12 peptides, which were identified as vaccine candidates for HLA-A24+ cancer patients, are administered into standard therapy failure patients with malignant glioma (glioblastoma) after confirmation of peptide-specific IgG in the patients. Primary endpoint is overall survival of the patients, and the secondary endpoints are progression free survival, 6 month survival rate, anti-tumor effect (clinical responses), adverse effects (evaluation of safety), and immunological responses

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Overall survival of peptide vaccination with BSC will be compared with that of BSC patients who are not enrolled this study.

Key secondary outcomes

1. Progression free survival of peptide vaccination with BSC will be compared with that of BSC group.
2. Six month survival rate of the 2 groups will be compared.
3. Anti-tumor effect (clinical responses) will be evaluated by RECIST criteria.
4. Adverse effects/safety will be evaluated by CTCAE v.3.0.
5. Evaluation of immunological effects (cytotoxic T lymphocytes (CTL), anti-peptide 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

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Vaccine

Interventions/Control_1

<1st treatment: total 8 times, every week>
Day 1: Select peptide candidates (up to 4), to which peptide-specific IgGs are detected before vaccination, and administer peptides (maximum 4) that showed the highest reactivity. Emulsion of the peptides is subcutaneously injected (3.0 mg/1.5 mL). Simultaneous BSC treatments are accepted.
Day 8,15,22,29,36,43,50: Inject subcutaneously the same peptides as those of the 1st injection.
Day 50-64: Final evaluation.

<2nd treatment: total 8 times, every 2 weeks>
The 2nd treatment would be continued according to the patient's request. The peptides are bi-weekly injected. When adverse effects would be observed, the interval of vaccination and the doses of peptides could be modified.

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

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

The subjects must satisfy the following conditions.
1. Patients must be diagnosed as glioblastoma pathologically and failure to radiation and/or chemotherapy.
2. Patients must be at a score level
of 0-2 of performance status (PS) (ECOG). Patient with PS3 is acceptable if limited to neural symptoms.
3. Patients must be positive for HLA-A24.
4. Patients must have IgG reactive to at least two of peptide candidates.
5. Patients must be expected to survive more than 3 months.
6. Patients must satisfy the followings:
WBC >3,000/mm3
Lymphocyte >900/mm3
Hb >8.0g/dL
Platelet >75,000/mm3
Serum Creatinine >2.0 mg/dL
Total Bilirubin >1.5 mg/dL
7. Patients must be more 20 years old.
8. Written informed consent must be obtained from patients.

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 multiple cancers
3) Patients with the past history of severe allergic reactions.
4) Patients who are not accept contraception during the 1st vaccination to 70 days after the last vaccination.
5) Patients with positive for hepatitis B or C virus.
6) Patients who are judged inappropriate for the clinical trial by doctors.

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Mizuhiko Terasaki

Organization

Kurume University School of Medicine

Division name

Department of Neurosurgery

Zip code

Address

Asahi-machi 67, Kurume,

TEL

0942-31-7570

Email

Name of contact person

1st name
Middle name
Last name

Organization

Kurume University School of Medicine

Division name

Department of Immunology

Zip code

Address

Asahi-machi 67, Kurume,

TEL

0942-31-7551

Homepage URL

Email

akiymd@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

Japan

Co-sponsor

Name of secondary funder(s)

The Ministry of Health, Labor and Welfare, Japan

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

2008

Year

07

Month

11

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

2008

Year

07

Month

08

Day

Date of IRB

Anticipated trial start date

2009

Year

04

Month

01

Day

Last follow-up date

2014

Year

03

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2008

Year

07

Month

10

Day

Last modified on

2015

Year

07

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001515