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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000001243
Receipt No. R000001515
Scientific Title Phase II clinical trial of personalized peptide vaccination for standard therapy failure patients with malignant glioma (glioblastoma)
Date of disclosure of the study information 2008/07/11
Last modified on 2015/07/07

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Basic information
Public title Phase II clinical trial of personalized peptide vaccination for standard therapy failure patients with malignant glioma (glioblastoma)
Acronym Personalized peptide vaccination for patients with glioblastoma
Scientific Title Phase II clinical trial of personalized peptide vaccination for standard therapy failure patients with malignant glioma (glioblastoma)
Scientific Title:Acronym Personalized peptide vaccination for patients with glioblastoma
Region
Japan

Condition
Condition malignant glioma (glioblastoma)
Classification by specialty
Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate clinical effects and safety of the peptide vaccine, peptides (maximum 4) among 12 peptides, which were identified as vaccine candidates for HLA-A24+ cancer patients, are administered into standard therapy failure patients with malignant glioma (glioblastoma) after confirmation of peptide-specific IgG in the patients. Primary endpoint is overall survival of the patients, and the secondary endpoints are progression free survival, 6 month survival rate, anti-tumor effect (clinical responses), adverse effects (evaluation of safety), and immunological responses
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Overall survival of peptide vaccination with BSC will be compared with that of BSC patients who are not enrolled this study.
Key secondary outcomes 1. Progression free survival of peptide vaccination with BSC will be compared with that of BSC group.
2. Six month survival rate of the 2 groups will be compared.
3. Anti-tumor effect (clinical responses) will be evaluated by RECIST criteria.
4. Adverse effects/safety will be evaluated by CTCAE v.3.0.
5. Evaluation of immunological effects (cytotoxic T lymphocytes (CTL), anti-peptide IgG) before and after peptide vaccination.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Vaccine
Interventions/Control_1 <1st treatment: total 8 times, every week>
Day 1: Select peptide candidates (up to 4), to which peptide-specific IgGs are detected before vaccination, and administer peptides (maximum 4) that showed the highest reactivity. Emulsion of the peptides is subcutaneously injected (3.0 mg/1.5 mL). Simultaneous BSC treatments are accepted.
Day 8,15,22,29,36,43,50: Inject subcutaneously the same peptides as those of the 1st injection.
Day 50-64: Final evaluation.

<2nd treatment: total 8 times, every 2 weeks>
The 2nd treatment would be continued according to the patient's request. The peptides are bi-weekly injected. When adverse effects would be observed, the interval of vaccination and the doses of peptides could be modified.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The subjects must satisfy the following conditions.
1. Patients must be diagnosed as glioblastoma pathologically and failure to radiation and/or chemotherapy.
2. Patients must be at a score level
of 0-2 of performance status (PS) (ECOG). Patient with PS3 is acceptable if limited to neural symptoms.
3. Patients must be positive for HLA-A24.
4. Patients must have IgG reactive to at least two of peptide candidates.
5. Patients must be expected to survive more than 3 months.
6. Patients must satisfy the followings:
WBC >3,000/mm3
Lymphocyte >900/mm3
Hb >8.0g/dL
Platelet >75,000/mm3
Serum Creatinine >2.0 mg/dL
Total Bilirubin >1.5 mg/dL
7. Patients must be more 20 years old.
8. Written informed consent must be obtained from patients.
Key exclusion criteria The following patients must be excluded:
1) Patients with severe symptoms (active and severe infectious disease, circulatory disease, respiratory disease, kidney disease, immunodeficiency, disturbance of coagulation).
2) Patients with multiple cancers
3) Patients with the past history of severe allergic reactions.
4) Patients who are not accept contraception during the 1st vaccination to 70 days after the last vaccination.
5) Patients with positive for hepatitis B or C virus.
6) Patients who are judged inappropriate for the clinical trial by doctors.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mizuhiko Terasaki
Organization Kurume University School of Medicine
Division name Department of Neurosurgery
Zip code
Address Asahi-machi 67, Kurume,
TEL 0942-31-7570
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kurume University School of Medicine
Division name Department of Immunology
Zip code
Address Asahi-machi 67, Kurume,
TEL 0942-31-7551
Homepage URL
Email akiymd@med.kurume-u.ac.jp

Sponsor
Institute Department of Immunology, Kurume University School of medicine
Institute
Department

Funding Source
Organization The Ministry of Education, Culture, Sports, Science, and Technology, Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s) The Ministry of Health, Labor and Welfare, Japan

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
2008 Year 07 Month 11 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 Terminated
Date of protocol fixation
2008 Year 07 Month 08 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2014 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 07 Month 10 Day
Last modified on
2015 Year 07 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001515

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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