- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00291473
Safety and Immunogenicity of CHP-HER2 and CHP-NY-ESO-1 Protein With OK-432 in Antigen-Expressing Cancers
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 Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Mie
-
Tsu, Mie, Japan, 514-8507
- Mie University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
adverse events
|
Secondary Outcome Measures
Outcome Measure |
---|
immune responses including HER2 and NY-ESO-1 specific IgG and T cells
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Hiroshi Shiku, M.D., Mie University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LMT2004-011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stomach Cancer
-
Jeeyun LeeRecruitingStomach Cancer, AdenocarcinomaKorea, Republic of
-
Chinese University of Hong KongUnknown
-
Chinese University of Hong KongUnknown
-
Ohio State University Comprehensive Cancer CenterPharmacia and UpjohnCompletedStomach Cancer | Esophageal Cancer | Cancer of Stomach | Esophagus CancerUnited States
-
BayerCompletedPrevention of Oesophagus Cancer and Stomach CancerUnited Kingdom
-
Chinese University of Hong KongRecruiting
-
Dana-Farber Cancer InstituteMassachusetts General Hospital; Genentech, Inc.; SCRI Development Innovations... and other collaboratorsCompletedStomach Cancer | Gastric Cancer | Esophageal CancerUnited States
-
Xijing Hospital of Digestive DiseasesCompletedStomach Cancer | Esophageal Cancer | Esophageal Dysplasia | Stomach DysplasiaChina
-
MacroGenicsMerck Sharp & Dohme LLCCompletedStomach Cancer | Gastric Cancer | Esophageal CancerKorea, Republic of, United States, Taiwan, Singapore, Canada
-
Dana-Farber Cancer InstituteMassachusetts General Hospital; Genentech, Inc.; Brigham and Women's HospitalCompletedStomach Cancer | Esophageal CancerUnited States
Clinical Trials on CHP-HER2, CHP-NY-ESO-1
-
ImmunoFrontier, Inc.Completed
-
Shenzhen University General HospitalRecruiting
-
Ludwig Institute for Cancer ResearchRoswell Park Cancer InstituteCompletedOvarian Cancer | Fallopian Tube Cancer | Peritoneal Cavity CancerUnited States
-
Ludwig Institute for Cancer ResearchCompletedProstate CancerSwitzerland, Germany
-
Ludwig Institute for Cancer ResearchNational Cancer Institute (NCI)CompletedOvarian Cancer | Fallopian Tube Cancer | Primary Peritoneal Cavity CancerUnited States
-
Instituto de Investigação em ImunologiaButantan InstituteUnknownCancer. | Melanoma. | Ovarian Cancer. | Lung Cancer.Brazil
-
Ludwig Institute for Cancer ResearchMemorial Sloan Kettering Cancer CenterCompletedFallopian Tube Cancer | Epithelial Ovarian Cancer | Primary Peritoneal CancerUnited States
-
Ludwig Institute for Cancer ResearchNYU Langone HealthCompletedTumorsUnited States
-
Sun Yat-sen UniversityGuangdong Xiangxue Precision Medical Technology Co., Ltd.Recruiting
-
Ludwig Institute for Cancer ResearchInstitute of Cancer Research, United KingdomCompletedMelanomaUnited Kingdom, Australia, New Zealand