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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008611
Receipt No. R000010124
Scientific Title A single-center open-label parallel-group study on the efficacy and the safety of survivin-2B peptide vaccine therapy for patients with advanced or recurrent digestive organ cancer, for which there is no effective treatment.
Date of disclosure of the study information 2012/08/03
Last modified on 2014/04/14

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Basic information
Public title A single-center open-label parallel-group study on the efficacy and the safety of survivin-2B peptide vaccine therapy for patients with advanced or recurrent digestive organ cancer, for which there is no effective treatment.
Acronym Phase I clinical study of survivin-2B peptide vaccine therapy for patients with advanced or recurrent digestive organ cancer, for which there is no effective treatment.(SUCCESS)
Scientific Title A single-center open-label parallel-group study on the efficacy and the safety of survivin-2B peptide vaccine therapy for patients with advanced or recurrent digestive organ cancer, for which there is no effective treatment.
Scientific Title:Acronym Phase I clinical study of survivin-2B peptide vaccine therapy for patients with advanced or recurrent digestive organ cancer, for which there is no effective treatment.(SUCCESS)
Region
Japan

Condition
Condition advanced or recurrent digestive organ cancer
Classification by specialty
Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We investigate the safety of survivin-2B peptide vaccine therapy for patients with advanced or recurrent digestive organ cancer in this study. In addition, we investigate the efficacy of this vaccine therapy, immunology assessment and contracting effect on cancer.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes The primary endpoint is safety: Then first we observe for adverse effects. Second, laboratory data, vital signs and weight are measured, and finally a 12-lead electrocardiogram is conducted.
Key secondary outcomes Secondary endpoints are immunological effects and shrinkage of cancer. Immunological effects are investigated as described below. SVN-2B peptide-specific CTL frequency is evaluated by tetramer analysis. SVN-2B peptide-specific CTL response is evaluated by enzyme linked immuno-sorbent spot (ELISPOT) assay. In addition, shrinkage of cancer is evaluated by CT or MRI imaging tests before vaccination and after the fourth treatment.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration Institution is considered as a block.
Blocking
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Vaccine
Interventions/Control_1 SVN-2B vaccine is injected under the skin at a dose of 0.3 mg/body combined with montanide ISA 51VG 1ml, once every two weeks. The treatment regimen is 4 doses.
Interventions/Control_2 SVN-2B vaccine is injected under the skin at a dose of 1.0 mg/body combined with montanide ISA 51VG 1ml, once every two weeks. The treatment regimen is 4 doses.
Interventions/Control_3 SVN-2B vaccine is injected under the skin at a dose of 3.0 mg/body combined with montanide ISA 51VG 1ml, once every two weeks. The treatment regimen is 4 doses.
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
85 years-old >
Gender Male and Female
Key inclusion criteria (1) Patients must have been given a definitive diagnosis of gastrointestinal carcinoma.
(2) In each patient it must be confirmed that survivin protein was expressed in cancer cells.
(3) Patients must meet 1 and 2 or 1 and 3 of the following criteria.
1) Inoperable status, with distant metastasis or recurrence.
2) Patients who will be administrate their first treatment because no standard chemotherapy was either advisable or available.
3) Did not respond sufficiently to the standard chemotherapy or could not tolerate the treatment.
(4) Have measurable lesion as determined by CT or MRI during the previous observation period.
(5) Patients must be HLA-A*2402 positive.
(6) Patients who have 1.6 or less log10 (1+CTLpre): CTLpre, the number of SVN-2B peputide-specific CTL in the previous observation period (the number of SVN-2B tetramer-positive CTL over 10,000 CD8-positive T cells by the tetramer analysis).
(7) Patients must have Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
(8) Patients who have been confirmed as having no serious organ failure within 30 days precious to registration (neutrophil >=1,500/uL, hemoglobin level >=8.0 g/dL, platelet count >=75*103/uL, 1.5 times serum creatinine level <= normal upper limit level, a total serum bilirubin level <= normal upper limit level, AST and ALT <=2 times normal upper limit level).
(9) Patients must be 20-85 years of age at the time of agreement.
(10) Patients must receive substantial and sufficient explanation of the content of this trial in all its aspects and provide.
Key exclusion criteria (1) Patients with an infection and who need systemic therapy such as antibiotics or antiviral medication.
(2) Patients who are positive in any test for HBV, HCV and HIV within 90 days before registration.
(3) Patients with any disorder that might preclude participation in the protocol, such as a history of severe heart failure, myocadinal infarction within 180 days before registration, arrhythmia requiring medical treatment, and those with severe obstructive lung disease.
(4) Patients with diabetes that cannot be controlled or those with hypertension.
(5) Patients with pleural effusion requiring drainage, pericardial fluid or ascites. (Patients who have had their drainage removed at least 14 days and who might be expected to participate safely, in this study, can be eligible.)
(6) Patients with brain metastatic disease and who have displayed any cranial nerve symptoms.
(7) Patients with any other life-threatening disease.
(8) Patients who cannot be evaluated adequately during the clinical course.
(9) Patients who have received SVN-2B in the past.
(10) Patients who are under treatment as described below itmes.
1) Surgery or radiotherapy.
2) Chemotherapy (including molecular targeted medicine).
3) Nitrosourea or MMC.
4) Endocrine therapy or immunotherapy (including the BRM therapy).
5) Blood transfusion,or hemopoietic factor.
6) Administration of immunosuppressive drug.
7) Other investigational new drugs or unlicensed drugs.
(11) Patients who are required to be administered steroids.
(12) Patients who have suffered from any side effect of a severity greater than Grade 2, as prescribed in CTCAE ver.4.03.
(13) Patients with a history of a serious drug allergy in the past.
(14) Pregnant women or those who are lactating.
(15) Patients who are determined as being an inappropriate study case by the trial responsibility physicians or trial allotment physicians.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toru Mizuguchi
Organization Sapporo medical university hospital
Division name Department of surgery (I)
Zip code
Address nishi 16 choume minami 1 jyo chuo-ku sapporo
TEL 011-611-2111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Toshihiko Torigoe
Organization Sapporo medical university
Division name Department of pathology (I)
Zip code
Address nishi 17 choume minami 1 jyo chuo-ku sapporo
TEL 011-611-2111
Homepage URL
Email

Sponsor
Institute Sapporo medical university hospital
Institute
Department

Funding Source
Organization Health, Labour and Welfare Ministry
Organization
Division
Category of Funding Organization
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 札幌医科大学附属病院

Other administrative information
Date of disclosure of the study information
2012 Year 08 Month 03 Day

Related information
URL releasing protocol
Publication of results Partially 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
2012 Year 07 Month 30 Day
Date of IRB
Anticipated trial start date
2012 Year 08 Month 30 Day
Last follow-up date
2013 Year 05 Month 30 Day
Date of closure to data entry
2013 Year 06 Month 06 Day
Date trial data considered complete
2014 Year 01 Month 20 Day
Date analysis concluded
2014 Year 01 Month 22 Day

Other
Other related information

Management information
Registered date
2012 Year 08 Month 03 Day
Last modified on
2014 Year 04 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010124

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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