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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000012774
Receipt No. R000014397
Scientific Title A phase I/II study for peptides cocktail vaccine in patients with progressive or recurrent malignant glioma.
Date of disclosure of the study information 2014/01/08
Last modified on 2019/01/14

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Basic information
Public title A phase I/II study for peptides cocktail vaccine in patients with progressive or recurrent malignant glioma.
Acronym Peptides cocktail vaccine for patients with progressive or recurrent malignant glioma.
Scientific Title A phase I/II study for peptides cocktail vaccine in patients with progressive or recurrent malignant glioma.
Scientific Title:Acronym Peptides cocktail vaccine for patients with progressive or recurrent 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 URLC10 (up-regulated lung cancer 10), DEPDC1 (DEP domain containing 1), FOXM1 (forkhead box M1), KIF20A (kinesin family member 20A), VEGFR1 (Vascular Endothelial Growth Factor Receptor 1), and VEGFR2 (Vascular Endothelial Growth Factor Receptor 2) peptides restricted to HLA-A*2402 in patients with progressive or recurrent 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 Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Vaccine
Interventions/Control_1 Subcutaneous injections of URLC10, DEPDC1, FOXM1, KIF20A, VEGFR1 and VEGFR2 peptides (1mg, respectively) with IFA. Weekly administration, 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
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 with temozolomide and irradiation.
6) Over 4 weeks after chemotherapy and/or irradiation
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, Shinjuku-ku,
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,
TEL 03-5363-3808
Homepage URL
Email todam@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)

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(Tokyo)

Other administrative information
Date of disclosure of the study information
2014 Year 01 Month 08 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
2013 Year 11 Month 14 Day
Date of IRB
Anticipated trial start date
2013 Year 12 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
2014 Year 01 Month 07 Day
Last modified on
2019 Year 01 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014397

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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