UMIN-CTR Clinical Trial

Public title

A phase II randomized clinical trial of personalized peptide vaccination in combination with Japanese herbal medicines for castration-resistant prostate cancer (CRPC)

Acronym

Personalized peptide vaccination with Japanese herbal medicines for CRPC

Scientific Title

A phase II randomized clinical trial of personalized peptide vaccination in combination with Japanese herbal medicines for castration-resistant prostate cancer (CRPC)

Scientific Title:Acronym

Personalized peptide vaccination with Japanese herbal medicines for CRPC

Region

Japan

Condition

Castration-resistant prostate cancer

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The aim of study is to investigate the immunity-enhancing effects, safety , clinical efficacy of personalized peptide vaccination in combination with Japanese herbal medicines (hochuekkito and keishibukuryogan) for castration-resistant prostate cancer patients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Comparison of immune-enhancing effects between two groups.

Key secondary outcomes

1. Comparison of peptide-specific CTL responses in PBMCs between two groups.
2. Comparison of safety between two groups.
3. Comparison of overall survival between two groups .

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Vaccine

Interventions/Control_1

A: Personalized peptide vaccination with oral herbal medicines treatment.
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. Emulate these peptides individually and subcutaneously inject them separately (3.0 mg/1.5-3.0 ml/peptide) every 1 week interval. Start oral use of hochuekkito (7.5g/day, 3X, 50 days) and keishibukuryougan (7.5g/dau, 3X, 50 days) on the same day with peptide vaccination. 1st treatment: total 8 times, every weeks)
If the patients want to continue the vaccination after completion of the first cycle of 6 vaccinations, the peptide vaccination will be allowed to continue (every 2-4 weeks) until unacceptable toxicity or withdrawal of consent.

Interventions/Control_2

B: Personalized peptide vaccine alone
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. Emulate these peptides individually and subcutaneously inject them separately (3.0 mg/1.5-3.0 ml/peptide) every 1 week interval. If the patients want to continue the vaccination after completion of the first cycle of 6 vaccinations, the peptide vaccination will be allowed to continue (every 2-4 weeks) until unacceptable toxicity or withdrawal of consent.

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

85

years-old

>

Gender

Male

Key inclusion criteria

The subjects must satisfy the following conditions.
1) Patients must be diagnosed as prostate cancer pathologically at the initial treatment. The patients must be suffering from castration-resistant prostate cancer after standard treatment.
2) Patients must be at a score level
of 0-1 of performance status (PS) (ECOG).
3) Patients must be positive for HLA-A2, HLA-A24, HLA-A26 or HLA-A3 super type.
4) Patients must have IgG reactive to at least two of peptide the candidate peptides restricted to the patient's HLA types.
5) If patients have used previously hochuekkito and/or keishibukuryougan, patients must wait a treatment for 4 weeks.
6) Patients must be expected to survive more than 3 months.
7) Patients must satisfy the followings:
WBC >and= 2,500/mm3
Lymphocyte >and=1,000/mm3
Hb >and= 8.0g/dl
Platelet >and= 100,000/mm3
Serum Creatinine <and= 2.5x upper limit of normal
Total Bilirubin <and=2x upper limit of normal
8) Patients must be more 20 year-old.
9) 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)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. 2) Patients with the past history of severe allergic reactions.
3) Patients who are judged inappropriate for the clinical trial by doctors.
4) Patients who do not accept contraception from the 1st vaccination until 70 days after the last vaccination.
5) Patients who are judged inappropriate for entry to this clinical trial by doctors.

Target sample size

70

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	Akira Yamada

Organization

Kurume University School of Medicine

Division name

Research Center for Innovative Cancer Therapy, Division of Cancer Vaccine

Zip code

Address

Asahi-machi 67, Kurume,

TEL

0942-31-7572

Homepage URL

Email

noguci@med.kurume-u.ac.jp

Institute

Kurume University School of medicine, Department of Immunology and Immunotherapy

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)

Kurume University

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(福岡県) Kurume University Medical Center(Fukuoka)

Date of disclosure of the study information

2013

Year

04

Month

01

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

2012

Year

11

Month

19

Day

Date of IRB

2012

Year

11

Month

19

Day

Anticipated trial start date

2013

Year

04

Month

01

Day

Last follow-up date

2019

Year

11

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

03

Month

21

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=R000012051