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 - NY-ESO-1 protein with Poly ICLC cancer vaccine

Gastroenterological Surgery Osaka University Graduate School of Medicine0 个研究点目标入组 15 人开始时间: 2012年5月21日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•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.

发起方

Gastroenterological Surgery Osaka University Graduate School of Medicine