UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012146 |
|---|---|
| Receipt number | R000014189 |
| Scientific Title | A multi-center double-blind parallel-group placebo-control Phase II study on the efficacy of survivin-2B peptide vaccine therapy for patients with advanced or recurrent pancreatic cancer, and for which there is no effective treatment. |
| Date of disclosure of the study information | 2013/11/01 |
| Last modified on | 2018/11/26 11:00:22 |
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Basic information
Public title
A multi-center double-blind parallel-group placebo-control Phase II study on the efficacy of survivin-2B peptide vaccine therapy for patients with advanced or recurrent pancreatic cancer, and for which there is no effective treatment.
Acronym
Phase II clinical study of vaccine therapy using survivin-2B peptide/STI01 for patients with advanced or recurrent pancreatic cancer.
(SUCCESS-II)
Scientific Title
A multi-center double-blind parallel-group placebo-control Phase II study on the efficacy of survivin-2B peptide vaccine therapy for patients with advanced or recurrent pancreatic cancer, and for which there is no effective treatment.
Scientific Title:Acronym
Phase II clinical study of vaccine therapy using survivin-2B peptide/STI01 for patients with advanced or recurrent pancreatic cancer.
(SUCCESS-II)
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will investigate the efficacy of survivin-2B peptide vaccine therapy for patients with advanced or recurrent pancreatic cancer for which there is no effective treatment. Participants will be randomly assigned to one of the following three groups; SVN-2B/STI-01, SVN-2B/ STI-01placebo and SVN-2B placebo/ STI-01placebo. Primary endpoint is the comparison of time to progression among these three groups. Secondary endpoints are examination of immunological response, anti-tumor effect (RECIST ver1.1), and safety (examination of adverse effect CTCAE ver4.03).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Time to progression
Key secondary outcomes
1)Immunological response
a)SVN-2B peptide specific CTL number (Tetramer analysis)
b)SVN-2B peptide specific CTL activation(ELISPOT analysis)
2)Anti-tumor effect based on RECIST guideline
3)Safety
a)Adverse Effect
b)Laboratory Data
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Vaccine |
Interventions/Control_1
SVN-2B(Placebo),STI-01(Placebo)
Interventions/Control_2
SVN-2B,STI-01(Placebo)
Interventions/Control_3
SVN-2B,STI-01
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 with a definitive diagnosis of pancreatic adenocarcinoma or invasive ductal carcinoma of pancreas.
(2)Patients with expression of survivin protein in cancer cells.
(3)Patients must meet all of the following criteria.
a)Patients with inoperable status like distant metastasis, local recurrence or locally advanced cancer.
b)Patients with cancer which did not respond or intolerable to gemcitabine or TS-1.
c)Patients who could not receive or refused to receive either gemcitabine or TS-1.
(4)Patients with measurable lesion based on RECIST as determined by CT or MRI at screening period.
(5)Patients with HLA-A*2402 positive.
(6)Patients with ECOG Performance Status 0 or 1.
(7)Patients without serious organ failure within 30 days prior 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, 3 times total serum bilirubin level <= normal upper limit level, AST and ALT <=3 times normal upper limit level).
(8)Patients aged 20-85 years when providing informed consent.
(9)Patients who have received sufficient explanation of this trial.
Key exclusion criteria
(1)HIV positive.
(2)Heart disease under NYHA III or IV classification.
(3)Uncontrollablediabetes/hypertension.
(4)Pleural effusion/pericardial fluid/ascites).
(5)Brain metastatic.
(6)Multiple malignancies.
(7)Autoimmune disease.
(8)Under suspicion of severe inflammatory disease.
(9)History of interstitial pneumonia.
(10)Life-threatening diseases.
(11)History of immune cell therapy for cancer.
(12)Received followingtreatmentdesignated period prior to registration.
a)Surgery/radiotherapy.
b)Chemotherapy.
c)Endocrine therapy/immunotherapy.
d)Blood transfusion/hematopoietic factor.
e)Application of immunosuppressive drug.
f)Investigational/unlicensed drugs.
(13)Use of Sho-sai-koto/warfarin/ theophylline.
(14)Steroids use required.
(15)History of severe drug allergy.
(16)Sensitive to cow materials.
(17)Sensitive to biological preparation.(18)Severe psychosis/neurologic manifestation.
(19)Pregnant/lactating. Hope to conceive during trial/unable to use contraception.(20)Disqualified for trial by principal investigator.
Target sample size
71
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,Surgical Oncology and Science
Zip code
Address
nishi 16 choume minami 1 jyo Chuo-ku Sapporo
TEL
011-611-2111
tmizu@sapmed.ac.jp
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
torigoe@sapmed.ac.jp
Sponsor or person
Institute
Sapporo medical university hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and
Development
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
The University of Tokyo, The Institute of Medical Science
Kanagawa Cancer Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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（北海道）
東京大学医科学研究所附属病院（東京）
神奈川県立がんセンター（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | 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
| 2013 | Year | 10 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2016 | Year | 10 | Month | 27 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 15 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 21 | Day |
Date analysis concluded
| 2018 | Year | 01 | Month | 29 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 28 | Day |
Last modified on
| 2018 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014189
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