UMIN-CTR Clinical Trial

Public title

Phase II clinical trial of personalized peptide vaccination in patients with advanced/metastatic urotherial cancer previously treated with M-VAC chemotherapy

Acronym

Peptide vaccination for patients with advanced/metastatic urotherial cancer previously treated with M-VAC chemotherapy

Scientific Title

Phase II clinical trial of personalized peptide vaccination in patients with advanced/metastatic urotherial cancer previously treated with M-VAC chemotherapy

Scientific Title:Acronym

Peptide vaccination for patients with advanced/metastatic urotherial cancer previously treated with M-VAC chemotherapy

Region

Japan

Condition

Urotherial cancer

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Peptides (maximum 4) among 34 (12 for HLA-A2, 14 for HLA-A24 and 8 for HLA-A3 super type) peptides, which were identified as vaccine candidates for HLA-A2, HLA-A24 or HLA-A3 super type positive advanced/metastatic urotherial cancer patients, are administered into urotherial cancer patients after confirmation of peptide-specific IgG in patients. The aim of the study is to investigate adverse effects (evaluation of safety), anti-tumor effect (clinical responses), total survival of vaccinated patients, and immunological responses.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Evaluation (clinical responses) of anti-tumor effects of peptide vaccination.

Key secondary outcomes

1.Evaluation of immunological responses (cytotoxic T lymphocytes (CTL), CTL precursors, anti-peptide IgG) before and after peptide vaccination.
2.Subjective effects (pain due to metastatic lesion, symptoms based on urinary disturbance due to primary lesion, PS, progression of cancer / change of body weight according to improvement) and evaluation of quality of life based on FACT examination sheet. Evaluation of long-term prognosis (progression free survival and total survival).
3.Adverse effects of peptide vaccination / The safety of the protocol 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

Interventions/Control_1

(1st treatment:total 12 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. Emulate these peptides individually and subcutaneously inject them separately (3.0 mg/1.5-3.0 ml/peptide).
Day 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78: Inject subcutaneously the same peptides as those of the 1st injection at the same dose.
Day 85: Final evaluation.
The 1st treatment (total 12 times, every week) is finished, but the 2nd treatment would be continued according to the patient's request. The schedule will be determined based on the reactivity to peptides. When adverse effects would be observed, the interval of vaccination and the doses of peptides could be changed.

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

85

years-old

>

Gender

Male and Female

Key inclusion criteria

The subjects must satisfy the following conditions.
1)Patients must be diagnosed as urotherial cancer pthologically at the inithial treatment. The patients must be suffering from advanced/metastatic urotherial cancer after M-VAC (methotrexate, vinblastine, doxorubicine and cisplatin) chemotherapy.
2)Patients must be positive for HLA-A2, HLA-A24 or HLA-A3 super type.
3)Patients must have IgG reactive to at least one of peptide candidates.
4)When patients had received pre-therapies, including chemotherapy, immunotherapy, and radiation therapy, the vaccine therapy must be started at least more than 4 weeks after the last therapy. Patients showing anti-tumor effects or adverse effects of pre-therapy must be excluded.
5)Patients must be at a score level
of 0-1 of performance status (PS) (ECOG).
6)Patients must be expected to survive more than 3 months.
7)Patients must satisfy the followings:
WBC >= 3,000/mm3
Hb >= 8.0g/dl
Platelet >= 100,000/mm3
Lymphocyte >= 10,000/mm3
Serum Creatinine <= 1.5 mg/dl
Total Bilirubin <= 1.5 mg/dl
8)Patients must be negative for Hepatitis virus B/C.
9)Patients must be more 20 year-old and less 85 year-old.
10)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.
Patients who are judged inappropriate for the clinical trial by doctors.

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Nasanori Noguchi

Organization

Kurume University School of Medicine

Division name

Department of Urology

Zip code

Address

asahi-machi 67, Kurume,

TEL

0942-31-7572

Email

Name of contact person

1st name
Middle name
Last name	Akira Yamada

Organization

Kurume University School of Medicine

Division name

Research Center of Innovative Cancer Therapy, Cancer Vaccine Department Division

Zip code

Address

Asahi-machi 67, Kurume,

TEL

0942-31-7572

Homepage URL

Email

akiymd@med.kurume-u.ac.jp

Institute

Kurume University School of medicine, Department of Immunology

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

The Ministry of Health, Labor and Welfare, Japan

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

2008

Year

03

Month

10

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

2007

Year

12

Month

27

Day

Date of IRB

2007

Year

12

Month

27

Day

Anticipated trial start date

2008

Year

03

Month

01

Day

Last follow-up date

2012

Year

02

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2008

Year

03

Month

02

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=R000001288