UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023565 |
|---|---|
| Receipt number | R000027131 |
| Scientific Title | A phase I/II study for peptide vaccine of vascular endothelial growth factor receptor-1/2 in patients with progressive schwannoma from Neurofibromatosis type 2 |
| Date of disclosure of the study information | 2016/08/09 |
| Last modified on | 2024/08/15 21:24:38 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A phase I/II study for peptide vaccine of vascular endothelial growth factor receptor-1/2 in patients with progressive schwannoma from Neurofibromatosis type 2
Acronym
VEGFR 1/2 peptide vaccine for Neurofibromatosis type 2
Scientific Title
A phase I/II study for peptide vaccine of vascular endothelial growth factor receptor-1/2 in patients with progressive schwannoma from Neurofibromatosis type 2
Scientific Title:Acronym
VEGFR 1/2 peptide vaccine for Neurofibromatosis type 2
Region
| Japan |
Condition
Condition
Neurofibromatosis type 2 with progressive schwannoma
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A phase I/II study to evaluate the safety and clinical efficacy of vaccine using VEGFR-1/2 peptides restricted to HLA-A*2402 or HLA-A*0201 in patients with progressive schwannoma from Neurofibromatosis type 2.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Safety and clinical efficacy of Vaccine therapy using VEGFR1 and VEGFR2 peptide for Neurofibromatosis type 2 with progressive schwannoma.
Key secondary outcomes
1) Progression free survival: PFS
2) Auditory activity: Word recognition scores (WRS), pure tone average (PTA), the American academy of otolaryngology- head and neck surgery (AAO-HNS) classifies hearing loss
3) QoL (Quality of Life): EORTC QLQ-C30, EORTC BN20, MDASI-BT
4) NCF (Neurocognitive Function): MMSE, HVLT-R, TMT, COWA
5) immune reaction (Cytotoxic T lymphocyte (CTL), TCR)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
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, 4 times and then monthly administration, 4 times; total 8 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
| 12 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Progressive schwannoma (Neurofibromatosis 2) without surgical and radiorogical justification
2) announcement of a diagnosis
3) HLA-A*2402,A*0201,A*0206 or A*0207
4) Age between 12 to 79
5) Performance status (ECOG) of 0-2
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) preventing conception
11) 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
10
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, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL
03-5363-3808
todam@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, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL
03-5363-3808
Homepage URL
http://www.neurosurgery.med.keio.ac.jp/medic/clinical_research.html
todam@keio.jp
Sponsor or person
Institute
Keio university school of medicine
Institute
Department
Personal name
Funding Source
Organization
no
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
| 2016 | Year | 08 | Month | 09 | 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
Completed
Date of protocol fixation
| 2016 | Year | 08 | Month | 09 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 09 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 09 | Day |
Last modified on
| 2024 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027131
