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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008826
Receipt No. R000010350
Scientific Title Phase II clinical trial of personalized peptide vaccination for patient with advanced endocrine malignant tumors resistant to standard therapies .
Date of disclosure of the study information 2012/08/31
Last modified on 2019/10/30

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Basic information
Public title Phase II clinical trial of personalized peptide vaccination for patient with advanced endocrine malignant tumors resistant to standard therapies .
Acronym Phase II clinical trial of personalized peptide vaccination for patient with advanced endocrine malignant tumors resistant to standard therapies .
Scientific Title Phase II clinical trial of personalized peptide vaccination for patient with advanced endocrine malignant tumors resistant to standard therapies .
Scientific Title:Acronym Phase II clinical trial of personalized peptide vaccination for patient with advanced endocrine malignant tumors resistant to standard therapies .
Region
Japan

Condition
Condition endocrine malignant tumors
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of study is to investigate the immunity-enhancing effects of personalized peptide vaccination for patient with malignancy resistant to standard therapies.

Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Immune-enhancing effects (changes in anti-peptide IgG titers in plasma)

Key secondary outcomes 1.Analyze the correlation between enhancement of peptide specific antibody and all over survival.
2. Adverse events of peptide vaccination. Adverse events are evaluated by the NCI-CTCAE.


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
Medicine Vaccine
Interventions/Control_1 The right peptides (up to 4 peptides) for vaccination to individual patients will be selected in consideration of the pre-existing host immunity assessed by the titers of anti-peptide IgG before vaccination, and subcutaneously injected with incomplete Freund's adjuvant every week (3.0 mg/each peptide; 6 times/cycle).
If the patients want to continue the vaccination after completion of the first cycle of 6 vaccinations, the peptide vaccination will be allowed to continue .
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
18 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 endocrine malignant tumors resistant to standard therapies. Measurable lesions are not required.
2) Patients must be at a score level 0-1 of ECOG performance status.

3) Patients must have IgGs reactive to at least two of the candidate peptides restricted to the patient's HLA types.
4)Patients must be expected to survive more than 3 months.
5) Patient's laboratory data must satisfy the followings:

WBC is more than 2,500/mm3
Lymphocyte is more than 900/mm3
Hb is more than 8.0g/dl
Platelet is more than 80,000/mm3
Serum Creatinine is less than 2 times the ULN
Total bilirubin are less than 2 times the ULN.(However, 2.5 or less times in the case of the patient of constitutional jaundice.)
6) Patients must be more 18 year-old.
7) Written informed consent must be obtained from patients.
8) Patients must be positive for HLA-A2, A24, A26, A3, A11, A31 or A33.
Key exclusion criteria The following patients must be excluded:
1) Patients with severe underlying diseases/conditions (active and severe infectious diseases, circulatory diseases, respiratory diseases, ranal diseases, immunodeficiencies, disturbance of coagulation, et al).
2) Patients with the past history of severe allergic reactions.
3) (Females) Pregnant or nursing patients. Patients desiring future fertility.
(Males) Patients who do not accept contraception from the 1st vaccination until 70 days after the last vaccination.
4) Patients who are judged inappropriate for entry to this clinical trial by doctors.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeru Yutani
Organization Kurume University

Division name Cancer Vaccine Center
Zip code
Address Kokubu-machi 155-1, Kurume, Fukuoka 839-0863
TEL 0942-27-5210
Email yutani@med.kurume-u.ac.jp

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 Development Division
Zip code
Address 67 Asahi-machi, Kurume, Fukuoka 830-0011, Japan
TEL 0942-31-7572
Homepage URL
Email akiymd@med.kurume-u.ac.jp

Sponsor
Institute Kurume University Cancer Vaccine Center
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2012 Year 08 Month 31 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 Completed
Date of protocol fixation
2012 Year 08 Month 23 Day
Date of IRB
2012 Year 08 Month 23 Day
Anticipated trial start date
2012 Year 09 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 08 Month 31 Day
Last modified on
2019 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010350

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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