UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase I/II study for peptide vaccine of vascular endothelial growth factor receptor-1/2 in patients with primary malignant glioma
Title of the study (Brief title)	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	Masahiro Toda
Organization	Keio University School of Medicine
Division name	Department of Neurosurgery
Address	35 Shinanomachi, Shinjyuku-ku, Tokyo
TEL	03-5363-3808
Email	todam@z2.keio.jp

Public contact
Name of contact person	Masahiro Toda
Organization	Keio University School of Medicine
Division name	Department of Neurosurgery
Address	35 Shinanomachi, Shinjyuku-ku, Tokyo
TEL	03-5363-3808
Homepage URL
Email	todam@z2.keio.jp

Sponsor
Institute	Department of Neurosurgery, Keio University School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 03 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015613