UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002409 |
|---|---|
| Receipt number | R000002947 |
| Scientific Title | Phase I / II clinical trial of peptide vaccination therapy for unresectable / recurrent gastric cancer to be refractory to chemotherapy by using new tumor antigen URLC10 and A2402 restrictive epitope peptide of the VEGFR1 origin related gene of tumor vascularization |
| Date of disclosure of the study information | 2009/08/31 |
| Last modified on | 2009/08/31 16:28:55 |
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Basic information
Public title
Phase I / II clinical trial of peptide vaccination therapy for unresectable / recurrent gastric cancer to be refractory to chemotherapy by using new tumor antigen URLC10 and A2402 restrictive epitope peptide of the VEGFR1 origin related gene of tumor vascularization
Acronym
Phase I / II clinical trial of peptide vaccination therapy for gastric cancer
Scientific Title
Phase I / II clinical trial of peptide vaccination therapy for unresectable / recurrent gastric cancer to be refractory to chemotherapy by using new tumor antigen URLC10 and A2402 restrictive epitope peptide of the VEGFR1 origin related gene of tumor vascularization
Scientific Title:Acronym
Phase I / II clinical trial of peptide vaccination therapy for gastric cancer
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The aim of the study is to investigate safety and overall survival time about cancer vaccination therapy by using new tumor antigen URLC10 and A2402 restrictive epitope peptide of the VEGFR1 origin related gene of tumor vascularization against patients who have unresectable / recurrent gastric cancer to be refractory to chemotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
safety
Key secondary outcomes
immunological response and clinocal efficacy
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
| Vaccine |
Interventions/Control_1
Cancer vaccination therapy by using new tumor antigen URLC10 and A2402 restrictive epitope peptide of the VEGFR1 origin related gene of tumor vascularization against patients who have unresectable / recurrent gastric cancer to be refractory to chemotherapy.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients who have unresectable / recurrent gastric cancer to be refractory to chemotherapy
2. Performance status (ECOG) of the patients are 0-2.
3. more than 20, less than 85 years of age.
4. The presence or absence of measurable or evaluable lesions by RECIST was not taken into account.
5. Patients who have undergone operation, and recovered the influence by surgery. Or two weeks or more have passed since pre-medical treatment.
6. Patients who can expect the survival of three months or more.
7. WBC count more than 3000/mm3, less than 15000/mm3. Plt count more than 75000/mm3. AST and ALT less than 150IU/L. T-Bil less than 3.0mg/dl. Creatinine less than 2.0mg/dl.
8. All patients gave written informed consent.
Key exclusion criteria
1. Pregnancy or lactation.
2. Patients have uncontrollable severe infectious diseases.
3. Patients have severe trauma.
4. Patients who are treated with steroid or immunosuppression agent during clinical trial.
5. Patients have uncontrollable double cancer.
6. Patients who have non-recovered injury.
7. Patients judged inappropriated by doctors.
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sumio Watanabe |
Organization
Juntendo University School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
2-1-1 Hongo Bunkyo-ku Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Juntendo University School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
TEL
0338133111
Homepage URL
Sponsor or person
Institute
Department of Gastroenterology, Juntendo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Juntendo University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
| 2009 | Year | 08 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
No longer recruiting
Date of protocol fixation
| 2009 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 08 | Month | 31 | Day |
Last modified on
| 2009 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002947
