Status:
COMPLETED
Safety and Immunogenicity of CHP-HER2 and CHP-NY-ESO-1 Protein With OK-432 in Antigen-Expressing Cancers
Lead Sponsor:
Ludwig Institute for Cancer Research
Collaborating Sponsors:
Mie University
Conditions:
Esophageal Cancer
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Mixed cancer vaccines, CHP-HER2 protein and CHP-NY-ESO-1 protein, are to be studied to evaluate the safety and immune responses in patients who are positive either or both antigens. Nine patients will...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2008
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00291473
Start Date
July 1 2005
End Date
August 1 2008
Last Update
March 3 2009
Active Locations (1)
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1
Mie University Hospital
Tsu, Mie-ken, Japan, 514-8507