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 antige
- Conditions
- Patients with NY-ESO-1-expressing advanced esophageal cancer, gastric cancer, lung cancer and malignant melanoma
- Registration Number
- JPRN-UMIN000007954
- Lead Sponsor
- Gastroenterological Surgery Osaka University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 15
Not provided
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
- Primary Outcome Measures
Name Time Method Toxicities and adverse events defined by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale.
- Secondary Outcome Measures
Name Time Method Humoral: NY-ESO-1 reactive antibodies measured by ELISA. Cellular: NY-ESO-1 specific CD4 and CD8 T-cells by cytokine secretion as determined by FACS analysis or ELISPOT assay. Tumor response will be assessed according to the Response Evaluation