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
1. Histological confirmation of cancer.
2. 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
or NY-ESO-1 expression by reverse transcriptase and polymerase chain reaction
(RT-PCR) analysis (Appendix 2), preferably, or immunohistochemistry
3. Patients must
1. 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
2. have metastatic disease, and treatment has failed, or in the situation where
effective therapy is not available, or has been refused.
4. Complete recovery from surgery (at least 4 weeks).
5. 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
6. Performance status > 70 (Karnofsky Scale) and life expectancy >3 months.
7. Age 18 years or more.
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
5. Previous bone marrow or stem cell transplant.
6. Metastatic disease to the central nervous system, unless treated and stable.
7. known HIV antibody positivity.
8. Anaphylactic reaction to previous vaccination.
9. Hypersensitivity to penicillin
10. Chemotherapy, any type of radiation therapy, or immunotherapy within 4 weeks before
study entry (6 weeks for nitrosoureas).
11. Concomitant treatment with steroids. Topical or inhalational steroids are permitted.
12. Participation in any other clinical trial involving another investigational agent
within 4 weeks prior to enrollment.
13. Pregnancy or nursing .
14. Refusal, by women of childbearing potential, to use medically acceptable means of
15. Mental impairment that may compromise the ability to give informed consent.
16. Lack of availability for immunological and clinical follow-up assessment.