UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001857 |
|---|---|
| Receipt number | R000002236 |
| Scientific Title | A phase I study of cancer vaccine with NY-ESO-1 overlapping peptides in patients with advanced cancers expressing NY-ESO-1 antigen |
| Date of disclosure of the study information | 2009/04/10 |
| Last modified on | 2016/10/12 10:43:34 |
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Basic information
Public title
A phase I study of cancer vaccine with NY-ESO-1 overlapping peptides in patients with advanced cancers expressing NY-ESO-1 antigen
Acronym
Cancer vaccine with NY-ESO-1 overlapping peptides
Scientific Title
A phase I study of cancer vaccine with NY-ESO-1 overlapping peptides in patients with advanced cancers expressing NY-ESO-1 antigen
Scientific Title:Acronym
Cancer vaccine with NY-ESO-1 overlapping peptides
Region
| Japan |
Condition
Condition
advanced esophageal cancer, stomach cancer, non-small cell lung cancer (NSCLC), malignant melanoma, bladder cancer.
Classification by specialty
| Gastroenterology | Pneumology | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery | Chest surgery | Dermatology |
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We identified the highly antigenic region in NY-ESO-1 molecule recognized by CD4 and CD8 T cells using an IFN-gamma secretion assay and individual overlapping peptides spanning the entire NY-ESO-1 protein for stimulation. Regions II(73-114) and III(121-144) were frequently recognized by either CD4 or CD8 T cells irrespective of patients' HLA type. Moreover, the most dominant peptide region (91-108) eliciting antibody response was also included in the region II. Based on these findings, we will investigate the safety and immunogenicity of four overlapping long peptides (NY-ESO-1 peptide #1(79-108); peptide #2(100-129); peptide #3(121-150); peptide #4(142-173))for cancer vaccine.
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
NY-ESO-1 specific immunity will be assessed using blood. NY-ESO-1 reactive antibodies measured by ELISA and cellular immunity by NY-ESO-1 specific CD4 and CD8 T cells by cytokine secretion as determined by FACS analysis will be assayed. Tumor response will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST). Disease status will be assessed at baseline and 2 weeks after the sixth vaccination in patients with evaluable (measurable and non-measurable) disease.
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 | Vaccine |
Interventions/Control_1
NY-ESO-1 OLP (4 peptides total 1 mg)+Montanide ISA-51 (1.0 mL)+ K-432 (Picibanil) (0.2 KE)
Every 2 weeks x 6 times
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
| 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.Advanced cancer patient.
3.Performance status of 0-2.
4.Age 20-80 years.
5.At least 4 weeks since radiotherapy, biological therapy, chemotherapy or surgery prior to first dosing of study agent.
6.Life expectancy > 3 months.
7.Laboratory values within the following limits:
WBC > 3000/mm3
Neutrophil count > 1500/mm3
Hemoglobin> 8.0 g/dL
Platelet count > 80,000/mm3
Serum bilirubin < 2.0 mg/dl
AST,ALT < 150 IU/l
Serum creatmine < 2.0 mg/dL
8.Tumor with NY-ESO-1 expression
9.Able and willing to give witnessed, written informed consent for participation in the trial
10.Evaluable tumor
9.no penicillin allergy
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
9
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiichi Nakayama |
Organization
Okayama University Graduate School of
Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Immunology
Zip code
Address
2-5-1 Shikata-cho, Okayama 700-8558, Japan
TEL
086-235-7187
nakayama@mw.kawasaki-m.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
Department of Surgery
Zip code
Address
2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL
06-6879-3251
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
Department of Immunology
Okayama University Graduate School of
Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
Ludwig Institute for Cancer Research, NY, USA
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
USA
Other related organizations
Co-sponsor
Department of Surgery and Clinical Oncology, Osaka University Graduate School of Medicine
Department of Immunotherapeutics
Graduate School of Medicine
The University of Tokyo
Name of secondary funder(s)
The Ministry of Education, Culture, Sports, Science and Technology of Japan.
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
川崎医大・呼吸器内科
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 04 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://ovidsp.tx.ovid.com/sp-3.22.1b/ovidweb.cgi?QS2=434f4e1a73d37e8c504983e01e46c99ab7186537abb996a
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
| 2009 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 04 | Month | 07 | Day |
Last modified on
| 2016 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002236
