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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001260
Receipt No. R000001534
Scientific Title A phase I study of vaccination with NY-ESO-1f peptide mixed with Picibanil; OK-432 and Montanide; ISA-51 in patients with cancers expressing NY-ESO-1 antigen
Date of disclosure of the study information 2008/07/24
Last modified on 2014/07/22

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Basic information
Public title A phase I study of vaccination with NY-ESO-1f peptide mixed with Picibanil; OK-432 and Montanide; ISA-51 in patients with cancers expressing NY-ESO-1 antigen
Acronym A phase I study of cancer vaccine with NY-ESO-1f peptide
Scientific Title A phase I study of vaccination with NY-ESO-1f peptide mixed with Picibanil; OK-432 and Montanide; ISA-51 in patients with cancers expressing NY-ESO-1 antigen
Scientific Title:Acronym A phase I study of cancer vaccine with NY-ESO-1f peptide
Region
Japan

Condition
Condition advanced esophageal cancer, stomach cancer, non-small cell lung cancer (NSCLC), malignant melanoma
Classification by specialty
Gastroenterology Pneumology Gastrointestinal surgery
Hepato-biliary-pancreatic surgery Dermatology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We identified the NY-ESO-1 peptide regions 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 a long peptide spanning a peptide region 91-110 in NY-ESO-1 for 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 immunitywill be assessed using blood obtained at baseline, every visit for vaccination and 4 weeks after the sixth vaccination. 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, week 13, and 4-6 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-1f peptide (600 µg)+Montanide ISA-51 (1.0 mL)+ K-432 (Picibanil) (0.2 KE)
Every 3 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 > 5 months.
7.Laboratory values within the following limits:
WBC > 3000/mm3
Neutrophil count > 1500/mm3
Hemoglobin> 8.0 g/dL
Platelet count > 100,000/mm3
Serum bilirubin < 2.0 mg/dl
AST,ALT < 150 IU/l
Serum creatmine < 2.0 mg/dL
8.Able and willing to give witnessed, written informed consent for participation in the trial
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 30

Research contact person
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

Public contact
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/surg2/www/cancer/shokudo/shugakuchiryo/ny-eso.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 (Medinet) Graduate School of Medicine
The University of Tokyo
Name of secondary funder(s) Ministry of Education, Culture, Sports, Science and Technology of Japan

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 川崎医科大学附属病院(岡山県)、大阪大学医学部附属病院(大阪府)、東京大学医学部附属病院(東京都)

Other administrative information
Date of disclosure of the study information
2008 Year 07 Month 24 Day

Related information
URL releasing protocol http://onlinelibrary.wiley.com/doi/10.1002/ijc.25955/pdf
Publication of results Published

Result
URL related to results and publications http://onlinelibrary.wiley.com/doi/10.1002/ijc.25955/pdf
Number of participants that the trial has enrolled
Results
We conducted a phase I clinical trial of a cancer vaccine using a 20-mer NY-ESO-1f peptide (NY-ESO-1 91-110) that includes multiple epitopes recognized by antibodies, and CD4 and CD8 T cells. Ten patients were immunized with 600 mcg of NY-ESO-1f peptide mixed with 0.2 KE Picibanil OK-432 and 1.25 ml Montanide ISA-51. Primary end points of the study were safety and immune response. Subcutaneous injection of the NY-ESO-1f peptide vaccine was well tolerated. Vaccine-related adverse events observed were fever (Grade 1), injection-site reaction (Grade 1 or 2) and induration (Grade 2). Vaccination with the NY-ESO-1f peptide resulted in an increase or induction of NY-ESO-1 antibody responses in nine of ten patients. The sera reacted with recombinant NY-ESO-1 whole protein as well as the NY-ESO-1f peptide. An increase in CD4 and CD8 T cell responses was observed in nine of ten patients. Vaccine-induced CD4 and CD8 T cells responded to NY-ESO-1 91-108 in all patients with various HLA types with a less frequent response to neighboring peptides. The findings indicate that the 20-mer NY-ESO-1f peptide includes multiple epitopes recognized by CD4 and CD8 T cells with distinct specificity. Of ten patients, two with lung cancer and one with esophageal cancer showed stable disease. Our study shows that the NY-ESO-1f peptide vaccine was well tolerated and elicited humoral, CD4 and CD8 T cell responses in immunized patients.
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
2007 Year 12 Month 18 Day
Date of IRB
Anticipated trial start date
2008 Year 02 Month 01 Day
Last follow-up date
2013 Year 12 Month 01 Day
Date of closure to data entry
2013 Year 12 Month 01 Day
Date trial data considered complete
2014 Year 06 Month 30 Day
Date analysis concluded
2014 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2008 Year 07 Month 22 Day
Last modified on
2014 Year 07 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001534

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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