UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase I study of vaccination with NY-ESO-1 protein mixed with Hiltonol(Poly ICLC), Picibanil(OK-432) and Montanide(ISA-51) in patients with cancers expressing NY-ESO-1 antigen
Title of the study (Brief title)	NY-ESO-1 protein with Poly ICLC cancer vaccine
Region	Japan

Condition
Condition	Patients with NY-ESO-1-expressing advanced esophageal cancer, gastric cancer, lung cancer and malignant melanoma
Classification by specialty	Gastroenterology Pneumology Gastrointestinal surgery Chest surgery Dermatology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Primary endpoint is safety. Secondary endpoints are NY-ESO-1 specific immunity and clinical responses.
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	Humoral: NY-ESO-1 reactive antibodies measured by ELISA. Cellular: NY-ESO-1 specific CD4 and CD8 T-cells by cytokine secretion as determined by FACS analysis or ELISPOT assay. Tumor response will be assessed according to the Response Evaluation

Base
Study type	Interventional

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

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Vaccine
Interventions/Control_1	NY-ESO-1 protein 200 microgram Montanide ISA-51
Interventions/Control_2	NY-ESO-1 protein 200microgram OK432 Poly-ICLC
Interventions/Control_3	NY-ESO-1 protein 200 microgram Montanide ISA-51 Poly-ICLC
Interventions/Control_4	NY-ESO-1 protein 200 microgram Montanide ISA-51 OK432 Poly-ICLC
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. At least 4 weeks since radiotherapy, biological therapy, chemotherapy or surgery prior to first dosing of study agent. 3. Laboratory values within the following limits: Hemoglobin > 8.0 g/dL Lymphocyte count 2,000/mm3 Platelet count 75,000/mm3 Serum creatinine 2.5 mg/dL Serum bilirubin 2.0 mg/dl AST/ALT 150 IU/l 4. Patients must have a ECOG performance status of 0-2. 5. Life expectancy 4 months. 6. Age 20 years. 7. Able and willing to give witnessed, written informed consent for participation in the trial (see Section 12.2) 8. Without allergy against Penicillin
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	15

Research contact person
Name of lead principal investigator	Yuichiro Doki
Organization	Osaka University Graduate School of Medicine
Division name	Gastroenterological Surgery
Address	2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL	0668793251
Email	hwada@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person	Hisashi Wada
Organization	Osaka University Graduate School of Medicine
Division name	Gastroenterological Surgery
Address	2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL	0668793251
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	Gastroenterological Surgery Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Gastroenterological Surgery Osaka University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kawasaki Medical School Hospital
Name of secondary funｄer(s)	Ludwig Institute for Cancer Research

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	大阪大学医学部附属病院 川崎医大附属病院

Other administrative information
Date of disclosure of the study information	2012 Year 05 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 03 Month 01 Day
Anticipated trial start date	2012 Year 06 Month 01 Day
Last follow-up date	2014 Year 03 Month 01 Day
Date of closure to data entry	2015 Year 09 Month 01 Day
Date trial data considered complete	2015 Year 12 Month 01 Day
Date analysis concluded	2016 Year 12 Month 01 Day

Related information
URL releasing protocol	http://www.med.osaka-u.ac.jp/pub/gesurg/consultation/jyobu_shouka/vaccine/index.html
Publication of results	Published
URL releasing results	http://journals.lww.com/immunotherapy-journal/Abstract/2017/05000/NY_ESO_1_Protein_Cancer_Vaccine_Wi
Results
Other related information

Management information
Registered date	2012 Year 05 Month 15 Day
Last modified on	2017 Year 05 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009366