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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000619
Receipt No. R000000751
Scientific Title Phase I clinical trial of pan-HLA type personalized peptide vaccine for advanced cancer patients
Date of disclosure of the study information 2007/03/01
Last modified on 2011/09/07

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Basic information
Public title Phase I clinical trial of pan-HLA type personalized peptide vaccine for advanced cancer patients
Acronym Pan-HLA type personalized peptide vaccine trial for cancer patients
Scientific Title Phase I clinical trial of pan-HLA type personalized peptide vaccine for advanced cancer patients
Scientific Title:Acronym Pan-HLA type personalized peptide vaccine trial for cancer patients
Region
Japan

Condition
Condition Advanced cancer patients who are refractory to standard therapies for cancer
Classification by specialty
Hepato-biliary-pancreatic medicine Pneumology Gastrointestinal surgery
Hepato-biliary-pancreatic surgery Obsterics and gynecology Dermatology
Urology Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of the study is to investigate adverse events (evaluation of safety) of pan-HLA type personalized peptide vaccine which applicable for almost all of cancer patients in Japanese and majority in the world. Patients, who are refractory to standard therapies for cancer, will be enrolled. Peptides (maximum 4) among 24 (each 8 for HLA-A2, -A24, and -A3 super type) peptides, which were identified as vaccine candidates for cancer patients, are administered subcutaneously. Vaccine peptide selection for each patient will be performed according to the reactivity of pre-vaccination plasma IgG to the candidate peptides.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Adverse events of peptide vaccine are evaluated based on the CTCAE v3.0 (JCOG version).
Key secondary outcomes Evaluation of immunological responses (cytotoxic T-lymphocytes , anti-peptide IgG) before and after vaccination.

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 Peptides (maximum 4) among 24 (each 8 for HLA-A2, -A24, and -A3 super type) peptides, which were identified as vaccine candidates for cancer patients, are administered with Freund incomplete adjuvant. Vaccine peptide selection for each patient will be performed according to the reactivity of pre-vaccination plasma IgG to the candidate peptides.
Each emulsified peptide (3 mg/peptide) are separately injected into subcutaneous once a week for 6-weeks (total 6 times). Chest X-ray and/or CT/MRI, and blood samples for hematology and biochemistry are taken at beginning and 1-week after the 6th vaccination.
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
80 years-old >
Gender Male and Female
Key inclusion criteria The subjects must satisfy the following conditions.
1) Patients must be pathologically diagnosed as cancer, and are refractory to standard therapies for cancer.
2) Patients must possess target lesions for response evaluation.
3) Patients must be positive for HLA-A2, -A3, -A11, -A24, -A31, or -A33.
4) Patients must have significant level of plasma IgG reactive to at least one of the vaccine candidate peptides.
5) When patients had received pre- therapies, including chemotherapy, immunotherapy, and radiation therapy, the vaccine therapy must be started more than 4 weeks after the last treatment. In case of 5FU and -related compounds, the vaccine therapy can be started more than 2 weeks of washout period. Patients must be not carried out anti-tumor effects or adverse effects of pre-therapy.
6) Patients must be at a score level of 0-2 of performance status (PS) (ECOG).
7) Patients must be expected to survive more than 3 months.
8) Patients must satisfy the followings:
WBC more than 3,000/mm3
Lymphocytes more than 1,000/mm3
Hb more than 9.0g/dl
Platelet more than 100,000/mm3
Serum Creatinine less than 1.4 mg/dl
Total Bilirubin less than 1.5 mg/dl
9) Patients must be negative for Hepatitis virus B/C.
10) Patients must be more 20 year-old and less 80 year-old.
11) Written informed consent must be obtained from patients.
Key exclusion criteria The following patients must be excluded:
1) Patients are negative for HLA-A2, -A3, -A11, -A24, -A31, and -A33.
2) Patients with severe symptoms (active and severe infectious disease, circulatory disease, respiratory disease, kidney disease, immunodeficiency, disturbance of coagulation etc).
3) Patients with the past history of severe allergic reactions.
4) Pregnant, nursing, or who wants pregnancy. Patients with no acceptance of use effective contraception during and for at least 70 days after study participation.
5) 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 Masanori Noguchi
Organization Kurume University School of Medicine
Division name Department of Urology
Zip code
Address Asahi-machi 67, Kurume,Fukuoka 830-0011, Japan
TEL 0942-31-7572
Email

Public contact
Name of contact person
1st name
Middle name
Last name Akira Yamada
Organization Kurume University
Division name Research Center for Innovative Cancer Therapy, Cancer Vaccine Department Division
Zip code
Address Asahi-machi 67, Kurume,Fukuoka 830-0011, Japan
TEL 0942-31-7744
Homepage URL http://www.med.kurume-u.ac.jp/med/sentanca/examine.html
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
2007 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2007 Year 02 Month 22 Day
Date of IRB
Anticipated trial start date
2007 Year 03 Month 01 Day
Last follow-up date
2011 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
2007 Year 02 Month 27 Day
Last modified on
2011 Year 09 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000751

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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