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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007954
Receipt No. R000009366
Scientific Title 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
Date of disclosure of the study information 2012/05/21
Last modified on 2017/05/19

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Basic information
Public title 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
Acronym NY-ESO-1 protein with Poly ICLC cancer vaccine
Scientific Title 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Yuichiro Doki
Organization Osaka University Graduate School of Medicine
Division name Gastroenterological Surgery
Zip code
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
1st name
Middle name
Last name Hisashi Wada
Organization Osaka University Graduate School of Medicine
Division name Gastroenterological Surgery
Zip code
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

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol http://www.med.osaka-u.ac.jp/pub/gesurg/consultation/jyobu_shouka/vaccine/index.html
Publication of results Published

Result
URL related to results and publications http://journals.lww.com/immunotherapy-journal/Abstract/2017/05000/NY_ESO_1_Protein_Cancer_Vaccine_Wi
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

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 03 Month 01 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000009366

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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