UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029005
Receipt number R000033187
Scientific Title VEGFR1/2 Peptide Vaccine in Patients with Recurrent, Progressive and Refractory Brain Tumors
Date of disclosure of the study information 2017/10/01
Last modified on 2018/10/15 17:22:48

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Basic information

Public title

VEGFR1/2 Peptide Vaccine in Patients with Recurrent, Progressive and Refractory Brain Tumors

Acronym

VEGFR 1/2 Peptide Vaccine for Recurrent, Progressive and Refractory Brain Tumors

Scientific Title

VEGFR1/2 Peptide Vaccine in Patients with Recurrent, Progressive and Refractory Brain Tumors

Scientific Title:Acronym

VEGFR 1/2 Peptide Vaccine for Recurrent, Progressive and Refractory Brain Tumors

Region

Japan


Condition

Condition

Recurrent, Progressive and Refractory Brain Tumors(hemangiopericytoma, hemangioblastoma, WHO grade II or III meningioma, chordoma, ependymoma)

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, A*0201 in patients with recurrent, progressive and refractory brain tumors (hemangiopericytoma, hemangioblastoma, WHO grade IIor III meningioma, chordoma, ependymoma).

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 recurrent, progressive and refractory brain tumors

Key secondary outcomes

1 Progression free survival: PFS
2 QoL (Quality of Life):EORTC QLQ-C30,EORTC BN20,MDASI-BT
3 NCF (Neurocognitive Function):MMSE,HVLT-R,TMT,COWA
4 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

Central registration


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) recurrent, progressive and refractory brain tumors (hemangiopericytoma, hemangioblastoma, WHO grade II or III meningioma, chordoma, ependymoma) without surgical and radiorogical justification
2) announcement of a diagnosis
3) HLA-A*2402, A*0201, A*0206, 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

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, Shinano-machi, Shinjuku-ku, Tokyo

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, Shinano-machi, Shinjuku-ku, Tokyo

TEL

03-5363-3808

Homepage URL

http://www.neurosurgery.med.keio.ac.jp/medic/clinical_research.html

Email

todam@keio.jp


Sponsor or person

Institute

Keio university school of medicine

Institute

Department

Personal name



Funding Source

Organization

Keio university school of medicine

Organization

Division

Category of Funding Organization

Other

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

2017 Year 10 Month 01 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

2017 Year 09 Month 05 Day

Date of IRB


Anticipated trial start date

2017 Year 10 Month 01 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

2017 Year 09 Month 05 Day

Last modified on

2018 Year 10 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033187


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name