Safety and Immunogenicity of CHP-HER2 and CHP-NY-ESO-1 Protein With OK-432 in Antigen-Expressing Cancers
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ClinicalTrials.gov Identifier: NCT00291473 |
Recruitment Status :
Completed
First Posted : February 14, 2006
Last Update Posted : March 3, 2009
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Condition or disease | Intervention/treatment | Phase |
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Esophageal Cancer Lung Cancer Stomach Cancer Breast Cancer Ovarian Cancer | Drug: CHP-HER2, CHP-NY-ESO-1 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 9 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | July 2005 |
Actual Primary Completion Date : | August 2008 |
Actual Study Completion Date : | August 2008 |

- adverse events
- immune responses including HER2 and NY-ESO-1 specific IgG and T cells

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histological confirmation of cancer.
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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
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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).
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00291473
Japan | |
Mie University Hospital | |
Tsu, Mie, Japan, 514-8507 |
Principal Investigator: | Hiroshi Shiku, M.D. | Mie University |
ClinicalTrials.gov Identifier: | NCT00291473 |
Other Study ID Numbers: |
LMT2004-011 |
First Posted: | February 14, 2006 Key Record Dates |
Last Update Posted: | March 3, 2009 |
Last Verified: | March 2009 |
Stomach Neoplasms Neoplasms by Site Neoplasms Gastrointestinal Neoplasms |
Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases |