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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Esophageal Cancer, Lung Cancer, Stomach Cancer, Breast Cancer, Ovarian Cancer

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Trial Information

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


Inclusion Criteria:



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
methodology).

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.

Exclusion Criteria:

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.

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
contraception.

15. Mental impairment that may compromise the ability to give informed consent.

16. Lack of availability for immunological and clinical follow-up assessment.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

adverse events

Principal Investigator

Hiroshi Shiku, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mie University

Authority:

Japan: Ethics Committee in Mie University

Study ID:

LMT2004-011

NCT ID:

NCT00291473

Start Date:

July 2005

Completion Date:

August 2008

Related Keywords:

  • Esophageal Cancer
  • Lung Cancer
  • Stomach Cancer
  • Breast Cancer
  • Ovarian Cancer
  • Breast Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Lung Neoplasms
  • Stomach Neoplasms
  • Ovarian Neoplasms

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