Unique ID issued by UMIN | UMIN000001081 |
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Receipt number | R000001314 |
Scientific 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 |
Date of disclosure of the study information | 2008/03/16 |
Last modified on | 2018/12/18 09:00:17 |
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
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
Safety and Immunogenicity of CHP-HER2 and CHP-NY-ESO-1 Protein With OK-432 in Antigen-Expressing Cancers
Japan |
Esophageal Cancer, Lung Cancer, Stomach Cancer, Breast Cancer, Ovarian Cancer
Gastroenterology | Hepato-biliary-pancreatic medicine | Pneumology |
Hematology and clinical oncology | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Chest surgery | Endocrine surgery | Breast surgery |
Obstetrics and Gynecology | Oto-rhino-laryngology | Urology |
Malignancy
NO
1)To assess safety of CHP-HER2 and CHP-NY-ESO-1 administered subcutaneously in combination with OK-432 to patients with cancers expressing HER2 and/or NY-ESO-1.
2)To measure immunity to HER2 and NY-ESO-1 (antibody, CD4+ and CD8+ T cells) induced by CHP-HER2 and CHP-NY-ESO-1 in combination with OK-432.
Others
To document tumor responses after immunization with CHP-HER2 and CHP-NY-ESO-1 in combination with OK-432.
Pragmatic
Phase I
1.Safety of CHP-HER2 and CHP-NY-ESO-1 administered subcutaneously in combination with OK-432 to patients with cancers expressing HER2 and/or NY-ESO-1.
2.Immunity to HER2 and NY-ESO-1 (antibody, CD4+ and CD8+ T cells)
Tumor responses
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
CHP-HER2 vaccine 300micrograms
CHP-NY-ESO-1 vaccine 100micrograms
OK-432 0.02mg
SQ injection, q2wks, 6 cycles
18 | years-old | <= |
Not applicable |
Male and Female
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 preferably, or immunohistochemistry
3.Patients must
a.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
b.have metastatic disease, and treatment has failed, or in the situation where effective therapy is not available, or has been refused.
3.Complete recovery from surgery (at least 4 weeks).
4.Laboratory values within the following limits:
Hemoglobin 9.0 g/dL or more(10.0 g/dL if <50 kg)
Neutrophil count 1.5x109/L or more
Lymphocyte count 0.5x109/L or more
Platelet count 100x109/L or more
Serum creatinine 1.8 mg/dL or less
Serum bilirubin 2mg/dL or less
5.Performance status > 70 (Karnofsky Scale) and life expectancy >3 months.
6. Age 20 years or more
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.
known HIV antibody positivity.
7.Anaphylactic reaction to previous vaccination.
8.Hypersensitivity to penicillin
Chemotherapy, any type of radiation therapy, or immunotherapy within 4 weeks before study entry (6 weeks for nitrosoureas).
9.Concomitant treatment with steroids. Topical or inhalational steroids are permitted.
10.Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment.
Pregnancy or nursing .
11.Refusal, by women of childbearing potential, to use medically acceptable means of contraception.
12.Mental impairment that may compromise the ability to give informed consent.
13.Lack of availability for immunological and clinical follow-up assessment.
9
1st name | |
Middle name | |
Last name | Hiroshi Shiku |
Mie University Graduate School of Medicine
Department of Cancer Vaccine, Immuno-Gene Therapy
2-174, Ebobashi, Tsu, Mie, 514-8507 Japan
059-231-5187
kageyama@clin.medic.mie-u.ac.jp
1st name | |
Middle name | |
Last name | Shinichi Kageyama |
Mie University Graduate School of Medicine
Department of Immuno-Gene Therapy
2-174, Ebobashi, Tsu, Mie, 514-8507 Japan
059-231-5187
kageyama@clin.medic.mie-u.ac.jp
Mie University Graduate School of Medicine, Kitano Hospital
Mie University Graduate School of Medicine
Self funding
Japan
Ludwig Institute for Cancer Research
YES
NCT00291473
ClinicalTrial.gov (NIH, USA)
2008 | Year | 03 | Month | 16 | Day |
Published
Completed
2006 | Year | 05 | Month | 11 | Day |
2006 | Year | 05 | Month | 01 | Day |
2009 | Year | 03 | Month | 01 | Day |
2009 | Year | 03 | Month | 01 | Day |
2009 | Year | 03 | Month | 01 | Day |
2009 | Year | 03 | Month | 01 | Day |
2008 | Year | 03 | Month | 16 | Day |
2018 | Year | 12 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001314
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