Safety and Immunogenicity of Cholesterol-Bearing Hydrophobized Pullulan HER2 Protein 146 (CHP-HER2) and NY-ESO-1 Protein (CHP-NY-ESO-1) in Combination With OK-432 in HER2- and/or NY-ESO-1-Expressing Cancers
- Conditions
- Esophageal Cancer, Lung Cancer, Stomach Cancer, Breast Cancer, Ovarian Cancer
- Registration Number
- JPRN-UMIN000001081
- Lead Sponsor
- Mie University Graduate School of Medicine, Kitano Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 9
Not provided
1.Clinically significant heart disease (NYHA Class III or IV). 2.Cardiac dysfunction; less than 50% of ejection fraction by echocardiogram. 3.Immunodeficiency disease. 4.Other serious illnesses, eg, serious infections requiring antibiotics, bleeding disorders. 5.Previous bone marrow or stem cell transplant. 6.Metastatic disease to the central nervous system, unless treated and stable. known HIV antibody positivity. 7.Anaphylactic reaction to previous vaccination. 8.Hypersensitivity to penicillin Chemotherapy, any type of radiation therapy, or immunotherapy within 4 weeks before study entry (6 weeks for nitrosoureas). 9.Concomitant treatment with steroids. Topical or inhalational steroids are permitted. 10.Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment. Pregnancy or nursing . 11.Refusal, by women of childbearing potential, to use medically acceptable means of contraception. 12.Mental impairment that may compromise the ability to give informed consent. 13.Lack of availability for immunological and clinical follow-up assessment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Safety of CHP-HER2 and CHP-NY-ESO-1 administered subcutaneously in combination with OK-432 to patients with cancers expressing HER2 and/or NY-ESO-1. 2.Immunity to HER2 and NY-ESO-1 (antibody, CD4+ and CD8+ T cells)
- Secondary Outcome Measures
Name Time Method Tumor responses