UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase I study of cancer vaccine with NY-ESO-1 overlapping peptides in patients with advanced cancers expressing NY-ESO-1 antigen
Title of the study (Brief title)	Cancer vaccine with NY-ESO-1 overlapping peptides
Region	Japan

Condition
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

Objectives
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

Assessment
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.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
Name of lead principal investigator	Eiichi Nakayama
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Immunology
Address	2-5-1 Shikata-cho, Okayama 700-8558, Japan
TEL	086-235-7187
Email	nakayama@mw.kawasaki-m.ac.jp

Public contact
Name of contact person	Hisashi Wada
Organization	Osaka University Graduate School of Medicine
Division name	Department of Surgery
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

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

Funding Source
Organization	Ludwig Institute for Cancer Research, NY, USA
Organization
Division
Category of Funding Organization	Outside Japan
Nationality of Funding Organization	USA

Other related organizations
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.

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	川崎医大・呼吸器内科

Other administrative information
Date of disclosure of the study information	2009 Year 04 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 01 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://ovidsp.tx.ovid.com/sp-3.22.1b/ovidweb.cgi?QS2=434f4e1a73d37e8c504983e01e46c99ab7186537abb996a
Results
Other related information

Management information
Registered date	2009 Year 04 Month 07 Day
Last modified on	2016 Year 10 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000002236