Safety and Immunogenicity of CHP-HER2 and CHP-NY-ESO-1 Protein With OK-432 in Antigen-Expressing Cancers

Inclusion criteria

• Histological confirmation of cancer.
• HER2 expression in tumor cells scored as 1+ or more which should be confirmed by IHC using at least two antibodies (archived issue; see Appendix 1 and Reference 1 for methodology).

or NY-ESO-1 expression by reverse transcriptase and polymerase chain reaction (RT-PCR) analysis (Appendix 2), preferably, or immunohistochemistry

• Patients must

• are at high risk of recurrence, more than 25% of probability, after complete resection or even after post-operative adjuvant treatment, and effective adjuvant therapy is not available or refused; or
• have metastatic disease, and treatment has failed, or in the situation where effective therapy is not available, or has been refused.
• Complete recovery from surgery (at least 4 weeks).
• Laboratory values within the following limits:

Hemoglobin 9.0 g/dL or more, or 10.0 g/dL or more if <50 kg Neutrophil count >1.5 x 109/L Lymphocyte count >0.5 x 109/L Platelet count >100 x 109/L Serum creatinine ≤ 1.8 mg/dL Serum bilirubin ≤ 2 mg/dL

• Performance status > 70 (Karnofsky Scale) and life expectancy >3 months.
• Age 18 years or more.

Exclusion criteria

• Clinically significant heart disease (NYHA Class III or IV).
• Cardiac dysfunction; less than 50% of ejection fraction by echocardiogram.
• Immunodeficiency disease.
• Other serious illnesses, eg, serious infections requiring antibiotics, bleeding disorders.
• Previous bone marrow or stem cell transplant.
• Metastatic disease to the central nervous system, unless treated and stable.
• known HIV antibody positivity.
• Anaphylactic reaction to previous vaccination.
• Hypersensitivity to penicillin
• Chemotherapy, any type of radiation therapy, or immunotherapy within 4 weeks before study entry (6 weeks for nitrosoureas).
• Concomitant treatment with steroids. Topical or inhalational steroids are permitted.
• Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment.
• Pregnancy or nursing .
• Refusal, by women of childbearing potential, to use medically acceptable means of contraception.
• Mental impairment that may compromise the ability to give informed consent.
• Lack of availability for immunological and clinical follow-up assessment.