UMIN-CTR Clinical Trial

Public title

Phase I clinical trial of a mixed 20 peptides vaccine for castration-resistant prostate cancer (CRPC)

Acronym

Phase I clinical trial of a mixed 20 peptides vaccine for CRPC

Scientific Title

Phase I clinical trial of a mixed 20 peptides vaccine for castration-resistant prostate cancer (CRPC)

Scientific Title:Acronym

Phase I clinical trial of a mixed 20 peptides vaccine for CRPC

Region

Japan

Condition

Castration-resistant prostate cancer

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the safety, minimum immunological effective dose and efficacy of a mixed 20 peptides vaccine (KRM-20) in patients with castration-resistant prostate cancer (CRPC).

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I

Primary outcomes

Adverse effects of a mixed 20 peptides vaccine / The safety of the protocol is evaluated based on the CTCAEv4.

Key secondary outcomes

1.Evaluation of immunological responses (cytotoxic T lymphocytes [CTL]and anti-peptide IgG) and minimum immunological effective dose.
2.PSA (prostate-specific antigen) response.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

Concealment

Central registration

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

A: Mixed 20 peptides vaccine at a dose level of 6mg/0.15mL is subcutaneously injected once a week for 6 weeks.

Interventions/Control_2

B: Mixed 20 peptides vaccine at a dose level of 20mg/0.5mL is subcutaneously injected once a week for 6 weeks.

Interventions/Control_3

C: Mixed 20 peptides vaccine at a dose level of 60mg/1.5mL is subcutaneously injected once a week for 6 weeks.

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

80

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.
2) Patients who had progressive disease after androgen deprivation therapy either by castration or with luteinizing hormone-releasing hormone (LHRH) agonists.
3) Patients who had progressive disease after anti-androgen therapy including bicalutamide or flutamide.
4) Anti-androgen therapy is discontinued for at least 4 weeks before the first vaccination for patients receiving flutamide and 6 weeks for those receiving bicalutamide.
PSA progression is defined as at least 2 consecutive rises (>=25% from baseline) and level of >=5ng/mL in serum PSA taken over 2 weeks apart, in the setting of castration levels of testosterone. Radiological progressive disease is defined by CT, MRI or bone scan using RECIST criteria.
5) Patients have serum testosterone level >=50 ng/dL (0.5ng/mL)
6) Patients must be positive for HLA-A2, HLA-A24, HLA-A26 or HLA-A3 super type (A3,A11,A31,A33).
7) Written informed consent must be obtained from patients.
8) Patients must be more 20 year-old and less than 80 year-old.
9) Patients must be at a score level
of 0-1 of performance status (ECOG).
10) Patients must be expected to survive more than 12 weeks.
11) Patients must satisfy the followings:
WBC > 3,000/mm3
Lymphocyte > 1,000/mm3
Hb > 8.0g/dl
Platelet > 80,000/mm3
Serum Creatinine <= 2.5 x upper limit of normal
Total Bilirubin <= 2 x 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 prostate within the last 1 year before the treatment.
3) Immunosuppressive treatment using a systematic steroid within the last 1 year was not permitted except for using low-dose steroid.
4)Patients with severe symptoms (active and severe infectious disease, circulatory disease, respiratory disease, kidney disease, immunodeficiency, disturbance of coagulation).
5) Patients with active multiple cancers.
6) Patients with the past history of severe allergic reactions.
7)Patients who do not agree with contraception during treatment and until 70 days after treatment.
8) Patients who had enrolled in another trial within 6 months or who are treating in another trial.
9) Patients who had received any peptides consist of a mixed 20 peptides (KRM-20).
10)Patients who are difficult to participate in this trial because of psychiatric symptoms.
11)Patients who are judged inappropriate for the clinical trial by doctors.

Target sample size

15

Name of lead principal investigator

1st name
Middle name
Last name	Masanori Noguchi

Organization

Kurume University School of Medicine

Division name

Clinical Research Division of Research Center for Innovative Cancer Therapy

Zip code

Address

Asahi-machi 67, Kurume,

TEL

0942-31-7989

Email

Name of contact person

1st name
Middle name
Last name	Akira Yamada

Organization

Kurume University School of Medicine

Division name

Cancer Vaccine Division of Research Center for Innovative Cancer Therapy

Zip code

Address

Asahi-machi 67, Kurume,

TEL

0942-31-7572

Homepage URL

Email

Institute

Research Center for Innovative Cancer Therapy, Kurume University School of Medicine

Institute

Department

Personal name

Organization

The Ministry of Health, Labour and Welfare, Japan

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

1. Kyushu University Faculty of Medical Science, Fukuoka, Japan
2. Kitasato University School of Medicine, Kitasato, Japan
3. Dokkyo Medical University Koshigaya Hospital, Koshigaya, Japan

Name of secondary funder(s)

Kurume University School of Medicine

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

はい/Yes

Institutions

久留米大学病院(福岡県)、九州大学病院(福岡県)、北里大学病院(神奈川県)、獨協医科大学越谷病院(埼玉県)
Kurume University Hospital(Fukuoka), Kyushu University Hospital(Fukuoka), Kitasato University Hospital(Kanagawa), Dokkyo Medical University Koshigaya Hospital(Saitama)

Date of disclosure of the study information

2012

Year

06

Month

27

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

06

Month

11

Day

Date of IRB

Anticipated trial start date

2012

Year

06

Month

01

Day

Last follow-up date

2013

Year

01

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

06

Month

19

Day

Last modified on

2013

Year

06

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009678