A phase I study of cancer vaccine with NY-ESO-1 overlapping peptides in patients with advanced cancers expressing NY-ESO-1 antige

Phase 1

• Conditions: advanced esophageal cancer, stomach cancer, non-small cell lung cancer (NSCLC), malignant melanoma, bladder cancer.

• Registration Number: JPRN-UMIN000001857
• Lead Sponsor: Department of Immunology Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-04-10
• Study Completion: 2014-03-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified