UMIN-CTR Clinical Trial

Public title

A phase I study of cancer vaccine with NY-ESO-1 overlapping peptides in patients with advanced cancers expressing NY-ESO-1 antigen

Acronym

Cancer vaccine with NY-ESO-1 overlapping peptides

Scientific Title

A phase I study of cancer vaccine with NY-ESO-1 overlapping peptides in patients with advanced cancers expressing NY-ESO-1 antigen

Scientific Title:Acronym

Cancer vaccine with NY-ESO-1 overlapping peptides

Region

Japan

Condition

advanced esophageal cancer, stomach cancer, non-small cell lung cancer (NSCLC), malignant melanoma, bladder cancer.

Classification by specialty

Gastroenterology	Pneumology	Gastrointestinal surgery
Hepato-biliary-pancreatic surgery	Chest surgery	Dermatology
Urology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

We identified the highly antigenic region in NY-ESO-1 molecule recognized by CD4 and CD8 T cells using an IFN-gamma secretion assay and individual overlapping peptides spanning the entire NY-ESO-1 protein for stimulation. Regions II(73-114) and III(121-144) were frequently recognized by either CD4 or CD8 T cells irrespective of patients' HLA type. Moreover, the most dominant peptide region (91-108) eliciting antibody response was also included in the region II. Based on these findings, we will investigate the safety and immunogenicity of four overlapping long peptides (NY-ESO-1 peptide #1(79-108); peptide #2(100-129); peptide #3(121-150); peptide #4(142-173))for cancer vaccine.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I

Primary outcomes

Toxicities and adverse events defined by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale.

Key secondary outcomes

NY-ESO-1 specific immunity will be assessed using blood. NY-ESO-1 reactive antibodies measured by ELISA and cellular immunity by NY-ESO-1 specific CD4 and CD8 T cells by cytokine secretion as determined by FACS analysis will be assayed. Tumor response will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST). Disease status will be assessed at baseline and 2 weeks after the sixth vaccination in patients with evaluable (measurable and non-measurable) disease.

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

Medicine

Vaccine

Interventions/Control_1

NY-ESO-1 OLP (4 peptides total 1 mg)+Montanide ISA-51 (1.0 mL)+ K-432 (Picibanil) (0.2 KE)
Every 2 weeks x 6 times

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

80

years-old

>=

Gender

Male and Female

Key inclusion criteria

1.Histological diagnosis of any type of cancers expressing NY-ESO-1 antigen.
2.Advanced cancer patient.
3.Performance status of 0-2.
4.Age 20-80 years.
5.At least 4 weeks since radiotherapy, biological therapy, chemotherapy or surgery prior to first dosing of study agent.
6.Life expectancy > 3 months.
7.Laboratory values within the following limits:
WBC > 3000/mm3
Neutrophil count > 1500/mm3
Hemoglobin> 8.0 g/dL
Platelet count > 80,000/mm3
Serum bilirubin < 2.0 mg/dl
AST,ALT < 150 IU/l
Serum creatmine < 2.0 mg/dL
8.Tumor with NY-ESO-1 expression
9.Able and willing to give witnessed, written informed consent for participation in the trial
10.Evaluable tumor
9.no penicillin allergy

Key exclusion criteria

1.Clinically significant heart disease (i.e., NYHA class 3 congestive heart failure; myocardial infarction within the past six months; unstable angina; coronary angioplasty within the past 6 months; uncontrolled atrial or ventricular cardiac arrhythmias).
2.Other serious illnesses, e.g., serious infections requiring antibiotics, bleeding disorders.
3.Previous bone marrow or stem cell transplant.
4.History of immunodeficiency disease or autoimmune disease except vitiligo.
5.Metastatic disease to the central nervous system, unless treated and stable.
6.Other malignancy within 3 years prior to entry into the study, except for treated early-stage melanoma or non-melanoma skin cancer, or cervical carcinoma in situ.
7.Known HIV, positivity.
8.Concomitant treatment with steroids. Topical or inhalational steroids are permitted. (See also Section 6.7 for restrictions/recommendations on 'Ancillary Therapy'.)
9.Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dose of study agent.
10.Pregnancy or lactation.
11.Women of childbearing potential not using a medically acceptable means of contraception.
12.Psychiatric or addictive disorders that may compromise the ability to give informed consent.
13.Lack of availability of the patient for immunological and clinical follow-up assessment.

Target sample size

9

Name of lead principal investigator

1st name
Middle name
Last name	Eiichi Nakayama

Organization

Okayama University Graduate School of
Medicine, Dentistry and Pharmaceutical Sciences

Division name

Department of Immunology

Zip code

Address

2-5-1 Shikata-cho, Okayama 700-8558, Japan

TEL

086-235-7187

Email

nakayama@mw.kawasaki-m.ac.jp

Name of contact person

1st name
Middle name
Last name	Hisashi Wada

Organization

Osaka University Graduate School of Medicine

Division name

Department of Surgery

Zip code

Address

2-2 Yamadaoka, Suita, Osaka 565-0871, Japan

TEL

06-6879-3251

Homepage URL

http://www.med.osaka-u.ac.jp/pub/gesurg/consultation/jyobu_shouka/vaccine/index.html

Email

hwada@gesurg.med.osaka-u.ac.jp

Institute

Department of Immunology
Okayama University Graduate School of
Medicine, Dentistry and Pharmaceutical Sciences

Institute

Department

Personal name

Organization

Ludwig Institute for Cancer Research, NY, USA

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization

USA

Co-sponsor

Department of Surgery and Clinical Oncology, Osaka University Graduate School of Medicine

Department of Immunotherapeutics
Graduate School of Medicine
The University of Tokyo

Name of secondary funder(s)

The Ministry of Education, Culture, Sports, Science and Technology of Japan.

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

川崎医大・呼吸器内科

Date of disclosure of the study information

2009

Year

04

Month

10

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://ovidsp.tx.ovid.com/sp-3.22.1b/ovidweb.cgi?QS2=434f4e1a73d37e8c504983e01e46c99ab7186537abb996a

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

01

Month

01

Day

Date of IRB

Anticipated trial start date

2009

Year

03

Month

01

Day

Last follow-up date

2014

Year

03

Month

01

Day

Date of closure to data entry

2014

Year

09

Month

01

Day

Date trial data considered complete

2014

Year

09

Month

01

Day

Date analysis concluded

2014

Year

12

Month

01

Day

Other related information

Registered date

2009

Year

04

Month

07

Day

Last modified on

2016

Year

10

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002236