UMIN-CTR Clinical Trial

Public title

Phase II clinical trial of personalized peptide vaccination for patients with colon cancer refractory to standard treatment.

Acronym

Phase II clinical trial of personalized peptide vaccination for colon cancer patients.

Scientific Title

Phase II clinical trial of personalized peptide vaccination for patients with colon cancer refractory to standard treatment.

Scientific Title:Acronym

Phase II clinical trial of personalized peptide vaccination for colon cancer patients.

Region

Japan

Condition

colon cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Select vaccine peptides (up to 4) from 31 candidate peptides , to which peptide-specific IgGs are detected before vaccination. Individually emulsify these peptides with adjuvant and subcutaneously inject .The aim of the study is to investigate immunological responses.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

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

Key secondary outcomes

1.Analyze the correlation between enhancement of peptide specific antibody and all over survival.
2. Adverse effects and safety of peptide vaccination is evaluated based on the NCI-CTC.

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

After completion of Course 1 if the patient hopes, the treatment can be continued (at 2 week intervals ).

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

18

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 colon cancer of standard therapy failed.Presence of target lesion is not considered.
2) Patients must be at a score level
0~1 of performance status (PS) (ECOG).
3) Patients must have IgG reactive to at least two of candidate peptides.
4)Patients must be expected to survive more than 3 months.
6) Patients must satisfy the followings:
WBC is more than 2,500/mm3
Lymphocyte is more than 900/mm3
Hb is more than 8.0g/dl
Platelet is more than 50,000/mm3
Serum Creatinine is less than 2.0mg/dl
Total Bilirubin is less than 2.5mg/dl
6) Patients must be more 18year-old.
7) Written informed consent must be obtained from patients.
8) Patients must be positive for HLA-A2,HLA-A24, HLA-A26, or HLA-A3 super type.

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	Shigeru Yutani

Organization

Kurume University

Division name

Cancer Vaccine Center

Zip code

Address

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

TEL

0942-27-5210

Email

yutani@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, Japan

TEL

0942-31-7572

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

2011

Year

10

Month

06

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

03

Month

31

Day

Date of IRB

2009

Year

03

Month

31

Day

Anticipated trial start date

2009

Year

04

Month

01

Day

Last follow-up date

2019

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2011

Year

10

Month

06

Day

Last modified on

2019

Year

10

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007701