UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007954 |
|---|---|
| Receipt number | R000009366 |
| Scientific Title | A phase I study of vaccination with NY-ESO-1 protein mixed with Hiltonol(Poly ICLC), Picibanil(OK-432) and Montanide(ISA-51) in patients with cancers expressing NY-ESO-1 antigen |
| Date of disclosure of the study information | 2012/05/21 |
| Last modified on | 2017/05/19 09:09:39 |
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Basic information
Public title
A phase I study of vaccination with NY-ESO-1 protein mixed with Hiltonol(Poly ICLC), Picibanil(OK-432) and Montanide(ISA-51) in patients with cancers expressing NY-ESO-1 antigen
Acronym
NY-ESO-1 protein with Poly ICLC cancer vaccine
Scientific Title
A phase I study of vaccination with NY-ESO-1 protein mixed with Hiltonol(Poly ICLC), Picibanil(OK-432) and Montanide(ISA-51) in patients with cancers expressing NY-ESO-1 antigen
Scientific Title:Acronym
NY-ESO-1 protein with Poly ICLC cancer vaccine
Region
| Japan |
Condition
Condition
Patients with NY-ESO-1-expressing advanced esophageal cancer, gastric cancer, lung cancer and malignant melanoma
Classification by specialty
| Gastroenterology | Pneumology | Gastrointestinal surgery |
| Chest surgery | Dermatology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Primary endpoint is safety.
Secondary endpoints are NY-ESO-1 specific immunity and clinical responses.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Toxicities and adverse events defined by National Cancer Institute Common
Terminology Criteria for Adverse Events (CTCAE) Scale.
Key secondary outcomes
Humoral: NY-ESO-1 reactive antibodies measured by ELISA.
Cellular: NY-ESO-1 specific CD4 and CD8 T-cells by cytokine
secretion as determined by FACS analysis or ELISPOT assay.
Tumor response will be assessed according to the Response Evaluation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Vaccine |
Interventions/Control_1
NY-ESO-1 protein 200 microgram
Montanide ISA-51
Interventions/Control_2
NY-ESO-1 protein 200microgram
OK432
Poly-ICLC
Interventions/Control_3
NY-ESO-1 protein 200 microgram
Montanide ISA-51
Poly-ICLC
Interventions/Control_4
NY-ESO-1 protein 200 microgram
Montanide ISA-51
OK432
Poly-ICLC
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Histological diagnosis of any type of cancers expressing NY-ESO-1 antigen.
2. At least 4 weeks since radiotherapy, biological therapy, chemotherapy or
surgery prior to first dosing of study agent.
3. Laboratory values within the following limits:
Hemoglobin > 8.0 g/dL
Lymphocyte count 2,000/mm3
Platelet count 75,000/mm3
Serum creatinine 2.5 mg/dL
Serum bilirubin 2.0 mg/dl
AST/ALT 150 IU/l
4. Patients must have a ECOG performance status of 0-2.
5. Life expectancy 4 months.
6. Age 20 years.
7. Able and willing to give witnessed, written informed consent for participation in the
trial (see Section 12.2)
8. Without allergy against Penicillin
Key exclusion criteria
1. Clinically significant heart disease (i.e., NYHA class 3 congestive heart failure;
myocardial infarction within the past six months; unstable angina; coronary
angioplasty within the past 6 months; uncontrolled atrial or ventricular cardiac
arrhythmias).
2. Other serious illnesses, e.g., serious infections requiring antibiotics, bleeding
disorders.
3. Previous bone marrow or stem cell transplant.
4. History of immunodeficiency disease or autoimmune disease except vitiligo.
5. Metastatic disease to the central nervous system, unless treated and stable.
6. Other malignancy within 3 years prior to entry into the study, except for treated
early-stage melanoma or non-melanoma skin cancer, or cervical carcinoma in
situ.
7. Known HIV, positivity.
8. Concomitant treatment with steroids. Topical or inhalational steroids are
permitted. (See also Section 6.7 for restrictions/recommendations on 'Ancillary
Therapy'.)
9. Participation in any other clinical trial involving another investigational agent
within 4 weeks prior to first dose of study agent.
10. Pregnancy or lactation.
11. Women of childbearing potential not using a medically acceptable means of
contraception.
12. Psychiatric or addictive disorders that may compromise the ability to give
informed consent.
13. Lack of availability of the patient for immunological and clinical follow-up
assessment.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichiro Doki |
Organization
Osaka University Graduate School of Medicine
Division name
Gastroenterological Surgery
Zip code
Address
2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL
0668793251
hwada@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hisashi Wada |
Organization
Osaka University Graduate School of Medicine
Division name
Gastroenterological Surgery
Zip code
Address
2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL
0668793251
Homepage URL
http://www.med.osaka-u.ac.jp/pub/gesurg/consultation/jyobu_shouka/vaccine/index.html
hwada@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Gastroenterological Surgery
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Gastroenterological Surgery
Osaka University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kawasaki Medical School Hospital
Name of secondary funder(s)
Ludwig Institute for Cancer Research
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
大阪大学医学部附属病院
川崎医大附属病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 05 | Month | 21 | Day |
Related information
URL releasing protocol
http://www.med.osaka-u.ac.jp/pub/gesurg/consultation/jyobu_shouka/vaccine/index.html
Publication of results
Published
Result
URL related to results and publications
http://journals.lww.com/immunotherapy-journal/Abstract/2017/05000/NY_ESO_1_Protein_Cancer_Vaccine_Wi
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
| 2012 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 05 | Month | 15 | Day |
Last modified on
| 2017 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009366
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