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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name