UMIN-CTR Clinical Trial

Public title

A phase I trial of personalized peptide vaccination using long and short peptides in patients with metastatic cancer resistant to standard treatments

Acronym

New personalized peptide vaccination in patients with metastatic cancer

Scientific Title

A phase I trial of personalized peptide vaccination using long and short peptides in patients with metastatic cancer resistant to standard treatments

Scientific Title:Acronym

New personalized peptide vaccination in patients with metastatic cancer

Region

Japan

Condition

Metastatic cancer resistant to standard treatments

Classification by specialty

Gastroenterology	Hepato-biliary-pancreatic medicine	Urology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Up to 5 from the 31 candidate peptides, in which peptide-specific IgGs are detected before vaccination, are administered subcutaneously to metastatic cancer patients who failed standard treatments. The aim of this study is to investigate the safety, immunological responses, and changes of circulating tumor cell (CTC) of personalized peptide vaccination.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I

Primary outcomes

Adverse events (safety assessments)

Key secondary outcomes

1. Peptide-specific immune responses in PBMCs
2. Assessment of circulating tumor cells (CTC)

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

Personalized peptide vaccination:
One peptide is selected from 2 peptides restricted by HL-class II and 2 to 4 peptides are selected from 29 peptides restricted by HLA-class I based on higher peptide-specific IgG responses before vaccination. Select peptides(up to 5) are separately and subcutaneously injected (3.0 mg/1.5-3.0 ml/peptide) every 1 week interval for 6 times until unacceptable toxicity or withdrawal of consent.

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 pathologically diagnosed as malignant tumor.
2) Patients have metastatic disease.
3) Patients are resistant to standard treatments.
4) Patients must be positive for HLA-class I A (-A2, -A3, -A11,-A24, -A26,-A31 or -A33).
5) Patients must have IgG reactive to at least 1 peptide from 2 peptides restricted by HL-class II and 2 peptides from 29 peptides restricted by HLA-class I.
6) Patients must have at least 3 circulating tumor cells (CTC) measured by Cell Search.
7) Patients must be at a score level
of 0-1 of performance status (PS) (ECOG).
8) Written informed consent must be obtained from patients.
9) Patients must be more 20 year-old.
10) Patients must be expected to survive more than 3 months.
11) Patients must satisfy the followings:
WBC >and= 3,000/mm3
Lymphocyte >and=1,000/mm3
Hb >and= 8.0g/dl
Platelet >and= 80,000/mm3
Serum Creatinine <and= 2.5x upper limit of normal
Total Bilirubin <and=2x upper limit of normal

Key exclusion criteria

The following patients must be excluded:
1) Patients who had received pre-therapies including radiotherapy, chemotherapy or immunotherapy within 28 days before the treatment.
2) Patients who had received radiotherapy to the primary cancer lesion except for metastatic lesions within 2 weeks before the treatment.
3) Immunosuppressive treatment using a systematic steroid within the last 12 weeks was not permitted except for using low-dose steroid (less than 20mg as prednisolone).
4) Patients with severe symptoms (active and severe infectious disease, circulatory disease, respiratory disease, kidney disease, immunodeficiency, disturbance of coagulation).
5) Active double cancer (synchronous double cancer and metachronous double cancer within 5 disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) judged to have been cured with local treatment.
6) Patients with the past history of severe allergic reactions.
7) Patients who had enrolled in another trial within 6 months or who are treating in another trial.
8) Patients who had received any peptides using this study.
9) Patients who are difficult to participate in this trial because of psychiatric symptoms.
10) Patients who are judged inappropriate for entry to this clinical trial by doctors.

Target sample size

10

Name of lead principal investigator

1st name
Middle name
Last name	Masanori Noguchi

Organization

Kurume University School of Medicine

Division name

Research Center for Innovative Cancer Therapy, Division of Clinical Research

Zip code

Address

Asahi-machi 67, Kurume,

TEL

0942-31-7989

Email

noguchi@med.kurume-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Shigeru Yutani

Organization

Kurume University School of Medicine

Division name

Cancer Vaccine Center

Zip code

Address

Kokubu-machi 155-1, Kurume,

TEL

0942-27-5210

Homepage URL

Email

yutani@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

久留米大学医療センター(福岡)

Date of disclosure of the study information

2014

Year

02

Month

01

Day

URL releasing protocol

Publication of results

Published

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

12

Month

27

Day

Date of IRB

Anticipated trial start date

2014

Year

02

Month

03

Day

Last follow-up date

2014

Year

10

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

01

Month

31

Day

Last modified on

2015

Year

01

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015205