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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001081
Receipt No. 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

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Basic information
Public 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
Acronym Safety and Immunogenicity of CHP-HER2 and CHP-NY-ESO-1 Protein With OK-432 in Antigen-Expressing Cancers
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
Scientific Title:Acronym Safety and Immunogenicity of CHP-HER2 and CHP-NY-ESO-1 Protein With OK-432 in Antigen-Expressing Cancers
Region
Japan

Condition
Condition Esophageal Cancer, Lung Cancer, Stomach Cancer, Breast Cancer, Ovarian Cancer
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Pneumology
Hematology and clinical oncology Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Chest surgery Endocrine surgery Breast surgery
Obsterics and gynecology Oto-rhino-laryngology Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 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.


Basic objectives2 Others
Basic objectives -Others To document tumor responses after immunization with CHP-HER2 and CHP-NY-ESO-1 in combination with OK-432.
Trial characteristics_1
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes 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)
Key secondary outcomes Tumor responses

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 CHP-HER2 vaccine 300micrograms
CHP-NY-ESO-1 vaccine 100micrograms
OK-432 0.02mg
SQ injection, q2wks, 6 cycles
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key 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 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
Key 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.
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.
Target sample size 9

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Shiku
Organization Mie University Graduate School of Medicine
Division name Department of Cancer Vaccine, Immuno-Gene Therapy
Zip code
Address 2-174, Ebobashi, Tsu, Mie, 514-8507 Japan
TEL 059-231-5187
Email kageyama@clin.medic.mie-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinichi Kageyama
Organization Mie University Graduate School of Medicine
Division name Department of Immuno-Gene Therapy
Zip code
Address 2-174, Ebobashi, Tsu, Mie, 514-8507 Japan
TEL 059-231-5187
Homepage URL
Email kageyama@clin.medic.mie-u.ac.jp

Sponsor
Institute Mie University Graduate School of Medicine, Kitano Hospital
Institute
Department

Funding Source
Organization Mie University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Ludwig Institute for Cancer Research
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT00291473
Org. issuing International ID_1 ClinicalTrial.gov (NIH, USA)
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2008 Year 03 Month 16 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2006 Year 05 Month 11 Day
Date of IRB
Anticipated trial start date
2006 Year 05 Month 01 Day
Last follow-up date
2009 Year 03 Month 01 Day
Date of closure to data entry
2009 Year 03 Month 01 Day
Date trial data considered complete
2009 Year 03 Month 01 Day
Date analysis concluded
2009 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 03 Month 16 Day
Last modified on
2018 Year 12 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001314

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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