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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023565
Receipt No. 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 2017/09/11

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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 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
Email 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
Email todam@keio.jp

Sponsor
Institute Keio university school of medicine
Institute
Department

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
Email

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 Open public recruiting
Date of protocol fixation
2016 Year 08 Month 09 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 09 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
2016 Year 08 Month 09 Day
Last modified on
2017 Year 09 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027131

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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