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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000007493
Receipt No. R000008843
Scientific Title Phase I Clinical trial of personalized peptide vaccine in combination with humanized anti-IL6 receptor monoclonal antibody for refractory colorectal cancer patients
Date of disclosure of the study information 2012/03/13
Last modified on 2017/04/06

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Basic information
Public title Phase I Clinical trial of personalized peptide vaccine in combination with humanized anti-IL6 receptor monoclonal antibody for refractory colorectal cancer patients
Acronym Clinical trial of peptide vaccine in combination with anti-IL6 receptor antibody for refractory colorectal cancer patients

Scientific Title Phase I Clinical trial of personalized peptide vaccine in combination with humanized anti-IL6 receptor monoclonal antibody for refractory colorectal cancer patients
Scientific Title:Acronym Clinical trial of peptide vaccine in combination with anti-IL6 receptor antibody for refractory colorectal cancer patients

Region
Japan

Condition
Condition colorectal cancer patients refractory to conventional treatments

Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aims of this trial are to evaluate safety of personalized peptide vaccine in combination with anti-IL6 receptor antibody and to examine the specific immunological responses to vaccine for determining an optimal dose of anti-IL6 receptor antibody in refractory colorectal cancer patients, who showed elevated plasma IL-6 more than 3 pg/ml.

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

Assessment
Primary outcomes Safety (adverse events) of personalized peptide vaccine in combination with anti-IL6 receptor antibody.

Key secondary outcomes Specific immunological responses after peptide vaccine (anti-peptide IgG titers in plasma and peptide-specific CTL responses in PBMC) .


Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Vaccine
Interventions/Control_1 Anti-IL6 receptor antibody [Actemra (tocilizumab), Chugai Pharmaceutical Co; 0.5mg/kg (n=6), 2mg/kg (n=6), or 8mg/kg (n=6)] is intravenously administrated. After three days, a maximum of 4 peptides (3 mg/each peptide), which are selected based on the results of HLA typing and peptide-specific IgG titers, are subcutaneously administrated with incomplete Freund's adjuvant (Montanide ISA51, Seppic)once a week for consecutive 6 weeks. During the treatment, safety is evaluated.The dose of anti-IL6 receptor antibody is escalated, if the safty is confirmed in 6 independent patients at the same dose.



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 pathologically diagnosed as colorectal cancer, and refractory to conventional treatments. Target lesions for response evaluation are not essential. The term for wash out of previous treatments should be basically more than 4 weeks, and patients must show no clinical effects or adverse events of previous treatments.
2) Patients must show an elevation of plasma IL-6 more than 3 pg/ml before treatment.
3) Patients must be an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4) Patients must be a positive status for HLA-A2, -A3, -A11, -A24, -A26, -A31, or -A33.
6) Patients must possess positive IgG responses to at least two of the different vaccine candidate peptides in pre-treatment plasma.
4) Patients must have a life expectancy of at least 12 weeks.
6) Patients must satisfy the followings:
WBC is between 3,000/mm3 and 9,000/mm3.
Lymphocyte is more than 1,000/mm3
Hb is more than 8.0g/dl
Platelet is more than 120,000/mm3
Serum Creatinine is less than 1.5 times upper limit of normal.
Total Bilirubin, AST, and ALT are less than 2 times upper limit of normal.
8) Patients must be over 20 years old.
9) Written informed consent must be obtained from patients.
Key exclusion criteria The following patients must be excluded:
1) Patients with severe underlying diseases (active and severe infectious diseases, activa tuberculosis, circulatory diseases, respiratory diseases, renal diseases, immunodeficiency, disturbance of coagulation, etc).
2) Patients with active interstitial pneumonia or its past history.
3) Patients with active double cancer [synchronic double cancer or asynchronous double cancer with no more than 5-year disease-free period, excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) judged to have been cured by local treatment].


4) Patients with the past history of severe allergic reactions.
5) Patients with Castleman's disease, rheumatoid arthritis, or juvenile idiopathic arthritis or with the past history of them.
6) Patients with the past history of previous tretamnet with anti-IL-6 receptor antibody.
7) Patients with the past history of previous tretament with personalized peptide vaccine developed by Kurume University.
8) Pregnant, nursing, or who wants pregnancy. Patients with no acceptance of effective contraception during and for at least 70 days after study participation.
9) Patients with other inappropriate conditions for enrollment judged by the clinicians.
Target sample size 18

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

Division name Department of Immunology
Zip code
Address Asahi-machi 67, Kurume, Fukuoka 830-0011
TEL 0942-31-7551
Email tsasada@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 Asahi-machi 67, Kurume, Fukuoka 830-0011, Japan
TEL 0942-31-7744
Homepage URL
Email akiymd@med.kurume-u.ac.jp

Sponsor
Institute Kurume University Cancer Vaccine Center
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)

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 03 Month 13 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 Suspended
Date of protocol fixation
2012 Year 02 Month 23 Day
Date of IRB
Anticipated trial start date
2012 Year 03 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
2012 Year 03 Month 13 Day
Last modified on
2017 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008843

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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