UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001395 |
|---|---|
| Receipt number | R000001696 |
| Scientific Title | Phase I clinical study of Glypican-3 peptide vaccine in patients with advanced Hepatocellular carcinoma |
| Date of disclosure of the study information | 2008/09/26 |
| Last modified on | 2013/05/10 15:13:42 |
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Basic information
Public title
Phase I clinical study of Glypican-3 peptide vaccine in patients with advanced Hepatocellular carcinoma
Acronym
Phase I clinical study of Glypican-3 peptide vaccine in patients with Hepatocellular carcinoma
Scientific Title
Phase I clinical study of Glypican-3 peptide vaccine in patients with advanced Hepatocellular carcinoma
Scientific Title:Acronym
Phase I clinical study of Glypican-3 peptide vaccine in patients with Hepatocellular carcinoma
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will investigate the safety and GPC3-specific immune responses of GPC3-derived peptide vaccine, and determine the most effective dosage.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
1)Adverse effects of GPC3 vaccination.
2)GPC3-specific immune-responses to GPC3 vaccination.
Key secondary outcomes
1)Clinical response rate.
2)Monitoring the level of tumor markers.
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
Injection of HLA-A24- or -A2-restricted GPC3 peptide (EYILSLEEL or FVGEFFTDV) emulsified with Montanide ISA51 adjuvant.
Every 2 weeks, 3 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
Advanced HCC patient satisfying the following conditions,
1)Diagnosed as HCC
2)Age: 20-80 years old
3)ECOG performance status of 0-1
4)HLA-A24 or -A2 positive
5)Child-Pugh A or B
6)Meet the following criteria for organ functions.
1.WBC: more than 3,000/mm3
2.Hemoglobin: more than 8.0g/dL
3.Platelet: more than 50,000/mm3
4.Serum bilirubin: less than 3.0 mg/dL
5.Serum AST/ALT: less than 200U/L
6.Serum creatinine: less than 1.5 mg/dL
7)Survival period is expected to be more than 3 months.
8)Written informed consent has been obtained.
9)At least 4 weeks since last therapy for HCC.
Key exclusion criteria
1)Uncontrolled pleural effusion or ascites.
2)Metastatic disease to the brain.
3)There are other malignancies.
4)Active infection excluding HBV, HCV.
5)Positive for HIV.
6)Clinically significant heart disease. (myocardial infarction or unstable angina within the past six months, or uncontrolled cardiac arrhythmias)
7)There are severe complications including cardiac failure, renal failure, liver failure, active gastro-duodenal ulcer, ileus, and uncontrolled Diabetes Mellitus.
8)There is severe psychiatric disorder.
9)Pregnant or lactating woman, who are willing to be pregnant.
10)Past history of severe drug allergy.
11)Immunodeficiency, previous splenectomy, irradiation to the spleen.
12)Ongoing treatment with corticosteroid, or immunosuppressant drugs.
13)Previous allograft transplantation.
14)Responsible doctors judged the patient in appropriate for the trial.
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taira Kinoshita |
Organization
National Cancer Center Hospital East
Division name
Hepato-Biliary pancreatic Surgery division
Zip code
Address
6-5-1, Kashiwanoha, Kashiwa, Japan
TEL
04-7133-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuya Nakatsura |
Organization
Research Center for Innovative Oncology, National Cancer Center Hospital East
Division name
Section for Cancer Immunotherapy, Investigative Treatment Division
Zip code
Address
6-5-1, Kashiwanoha, Kashiwa, Japan
TEL
04-7131-5490
Homepage URL
tnakatsu@east.ncc.go.jp
Sponsor or person
Institute
Section for Cancer Immunotherapy,
Investigative Treatment Division, Research Center for Innovative Oncology, National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Health, Labor and Welfare, Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 09 | Month | 26 | 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 | 12 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 09 | Month | 26 | Day |
Last modified on
| 2013 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001696
