UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013381 |
|---|---|
| Receipt number | R000015613 |
| Scientific Title | A phase I/II study for peptide vaccine of vascular endothelial growth factor receptor-1/2 in patients with primary malignant glioma |
| Date of disclosure of the study information | 2014/03/10 |
| Last modified on | 2016/09/10 20:37:07 |
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Basic information
Public title
A phase I/II study for peptide vaccine of vascular endothelial growth factor receptor-1/2 in patients with primary malignant glioma
Acronym
VEGFR1/2 peptide vaccine for patients with primary malignant glioma
Scientific Title
A phase I/II study for peptide vaccine of vascular endothelial growth factor receptor-1/2 in patients with primary malignant glioma
Scientific Title:Acronym
VEGFR1/2 peptide vaccine for patients with primary malignant glioma
Region
| Japan |
Condition
Condition
Malignant glioma
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A phase I/II study to evaluate the safety and clinical efficacy of cancer vaccine using VEGFR-1/2 peptides restricted to HLA-A*2402 in patients with primary malignant glioma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
1) Safety
2) Clinical efficacy
Overall survival
Key secondary outcomes
1) Immunological responses
Induction of in vitro cytotoxic T
lymphocytes
T lymphocytes analyzed by HLA Tetramer
2) Clinical efficacy
Progression-free survival
Antitumor effects
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
Subcutaneous injection of VEGFR1 and VEGFR2 peptides (2mg, respectively) with IFA. Weekly administration, 8 times and then monthly administration, 6 times; total 14 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
| 16 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)malignant glioma
2) HLA-A*2402
3) Age between 16 to 79
4) Performance status (ECOG) of 0-2
5) After the postoperative treatment of irradiation with concurrent temozolomide.
6) Over 4 weeks after surgery, irradiation, or chemotherapy.
7) Sufficient function of important organs.
8) No uncontrollable pleural, peritoneal or cardiac effusion.
9) Expected survival time: more than 3 months.
10) Written informed consents are obtained.
Key exclusion criteria
1) Uncontrollable severe infectious diseases.
2) Serious concomitant diseases
3) Adverse event of NCI-CTC grade 3 or 4.
4) Unable to take anything orally over 24 hours.
5) Active multiple cancers.
6) Myeloproliferative diseases such as MDS and CML.
7) After allogeneic hematopoietic stem cell transplantation.
8) Active autoimmune diseases.
9) Severe drug allergy
10) Necessity for administration of steroid or immunosuppressive drugs.
11) Pregnancy or lactation. Patients hope pregnancy
12) Psychiatric disorders.
13) Unhealed injury.
14) Judged as inappropriate for this study by doctors.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Toda |
Organization
Keio University School of Medicine
Division name
Department of Neurosurgery
Zip code
Address
35 Shinanomachi, Shinjyuku-ku, Tokyo
TEL
03-5363-3808
todam@z2.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiro Toda |
Organization
Keio University School of Medicine
Division name
Department of Neurosurgery
Zip code
Address
35 Shinanomachi, Shinjyuku-ku, Tokyo
TEL
03-5363-3808
Homepage URL
todam@z2.keio.jp
Sponsor or person
Institute
Department of Neurosurgery, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
慶應義塾大学病院（東京都）/Keio University Hospital
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 03 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 10 | Day |
Last modified on
| 2016 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015613
