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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00291473
Recruitment Status : Completed
First Posted : February 14, 2006
Last Update Posted : March 3, 2009
Sponsor:
Collaborator:
Mie University
Information provided by:
Ludwig Institute for Cancer Research

Study Description
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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 be enrolled, who are refractory to standard therapies for cancer or at high risk to relapse. CHP-HER2 and CHP-NY-ESO-1 are subcutaneously given on bimonthly basis, together with OK-432(Picibanil) as an immunoadjuvant. Six doses will be given. Toxicity profiles will be monitored, and antigen specific humoral anad T cell responses will be described.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Lung Cancer Stomach Cancer Breast Cancer Ovarian Cancer Drug: CHP-HER2, CHP-NY-ESO-1 Phase 1

Study Design
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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

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. adverse events

Secondary Outcome Measures :
  1. immune responses including HER2 and NY-ESO-1 specific IgG and T cells

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Japan
Mie University Hospital
Tsu, Mie, Japan, 514-8507
Sponsors and Collaborators
Ludwig Institute for Cancer Research
Mie University
Investigators
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Principal Investigator: Hiroshi Shiku, M.D. Mie University
More Information
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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
Additional relevant MeSH terms:
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Stomach Neoplasms
Neoplasms by Site
Neoplasms
Gastrointestinal Neoplasms
 Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases