NIPH Clinical Trials Search

UMIN ID: UMIN000001260

Registered date:24/07/2008

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedadvanced esophageal cancer, stomach cancer, non-small cell lung cancer (NSCLC), malignant melanoma
Date of first enrollment2008/02/01
Target sample size30
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)NY-ESO-1f peptide (600 µg)+Montanide ISA-51 (1.0 mL)+ K-432 (Picibanil) (0.2 KE) Every 3 weeks x 6 times


Primary OutcomeToxicities and adverse events defined by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale.
Secondary OutcomeNY-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.

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum80years-old
GenderMale and Female
Include criteria
Exclude criteria1.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.

Related Information


public contact
Name Hisashi Wada
Address 2-2 Yamadaoka, Suita, Osaka 565-0871, Japan Japan
Telephone 06-6879-3251
Affiliation Osaka University Graduate School of Medicine Department of Surgery
scientific contact
Name Eiichi Nakayama
Address 2-5-1 Shikata-cho, Okayama 700-8558, Japan Japan
Telephone 086-235-7187
Affiliation Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Department of Immunology