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

UMIN ID: UMIN000001260

Registered date:24/07/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: advanced esophageal cancer, stomach cancer, non-small cell lung cancer (NSCLC), malignant melanoma
• Date of first enrollment: 2008/02/01
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional
• 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

Outcome(s)

• Primary Outcome: Toxicities and adverse events defined by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale.
• Secondary Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Department of Immunology Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
• Secondary 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
• Source(s) of Monetary Support: Ludwig Institute for Cancer Research, NY, USA,Ministry of Education, Culture, Sports, Science and Technology of Japan