UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007507 |
|---|---|
| Receipt number | R000008860 |
| Scientific Title | A phase II clinical study of cancer vaccine with Survivin helper peptide for patients with advanced/recurrent breast cancers |
| Date of disclosure of the study information | 2012/03/15 |
| Last modified on | 2015/09/14 09:46:28 |
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Basic information
Public title
A phase II clinical study of cancer vaccine with Survivin helper peptide for patients with advanced/recurrent breast cancers
Acronym
Cancer vaccine study with Survivin helper peptide for patients with breast cancers
Scientific Title
A phase II clinical study of cancer vaccine with Survivin helper peptide for patients with advanced/recurrent breast cancers
Scientific Title:Acronym
Cancer vaccine study with Survivin helper peptide for patients with breast cancers
Region
| Japan |
Condition
Condition
A phase II clinical study of cancer vaccine with Survivin helper peptide for patients with advanced/recurrent breast cancers
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate anti-tumor effects after repeated doses of Survivin-helper peptide vaccine for patients with advanced/recurrent breast cancers expressing Survivin antigen
Basic objectives2
Others
Basic objectives -Others
To re-evaluate adverse events and Survivin specific immune responses after Survivin helper peptide vaccine
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Tumor response: Clinical benefit rate (CBR), best over- all response assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) after Survivin helper peptide vaccine
Key secondary outcomes
Safety: profiles of adverse events,
Immune responses : Survivin-specific antibodies and T cell responses,
Tumor responses: Response rate, Disease control rate, Overall survival, Disease Free survival, Time to progression, Progression free survival, Median Survival time, Tumor markers: CEA, CA15-3, Diagnostic imaging: CT, MRI, US Echo, Bio-markers.
Evaluation of correlation between tumor responses and immune responses
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
| Medicine | Vaccine |
Interventions/Control_1
1st and 2nd duration of therapy: Subcutaneous injection of Survivin-hepler pepitde (1 mg) vaccine, mixed with Montanide and OK432 (Picibanil; 0.02 KE), at every two weeks, repeated 4 times
3rdduration of therapy:
Subcutaneous injection of Survivin-hepler pepitde (1 mg) vaccine, mixed with Montanide and OK432 (Picibanil; 0.02 KE), at every four weeks, repeated 4 times
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Aged 20 to 75 years
2) Histologically-confirmed malignant
breast cancer
3) Patients with therapy-resistant recurrent cancer treated at least one chemotherapy or radio therapy, or the patients who refuse the subsequent standard therapy
4) Performance status (ECOG) 0 to 2
5) At least six-month life expectancy
6) Normal bone-marrow, kidney and liver function, meeting the criteria below;
Neutrophils>1500/microL
Lymphocytes>500/microL
Platelets>100000/microL
Hemoglobin>8.0 g/dL
Serum serum bilirubin<2.0 mg/dL
Serum creatinine<2.0 mg/dL
7) Available for pathological specimen, more than 10 slides to perform immunostaining
8) Patients with PCR/ IHC-confirmed Survivin expressing tumor cells
9) Positive for HLA-DRB1*01:01, HLA-DRB1*08:03, HLA-DR53 (DR4/DR7/DR9), HLA-DQB1*06:01, HLA-DPB1*05:01.
10) Having written informed consent
Key exclusion criteria
1) Patients treated with other cancer therapy within 4 weeks before the first vaccine
2) Patients treated with cancer immunotherapy for Survivin
3) Severe bleeding disorders, meeting the criteria below;
PT<50%
APTT>60sec
4) Active infection (HIV, HBV or HCV HTLV-1)
5) Severe heart disease (NYHA class 3 or 4)
6) Autoimmune disease (scleroderma, Sjogren's syndrome, idiopathic thrombocytopenic purpura, multiple sclerosis, rheumatoid arthritis etc.)
7) Systemic administration of corticosteroid or immunosuppresive drugs during the study (Except local administration, inhaled drugs, and antiphlogistic analgetics).
8) Brain metastasis
9) Multiple primary cancer
10)Patients with adverse events more than Grade 3 (non-hematological toxicity ) or Grade 4 (hematological toxicity) based on CTCAEv4.0
11)Pregnant women or refuse anticonception during the study (both sexes)
Patient with impaired mental status in the study.
12) Lactating women or cannot stop lactation during the study.
13) Men refused anticonception during the study
14) Inappropriate for study entry judged by an attending physician.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yamashita Hiroko |
Organization
Hokkaido University Hospital
Division name
Department of Breast and Endocrine Surgery
Zip code
Address
Kita-14, Nishi-5, Kita-ku, Sapporo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kitamura Hidemitsu |
Organization
Division of Immunoregulation, Institute for Genetic Medicine, Hokkaido University
Division name
Bureau of Survivin peptide vaccine clinical study
Zip code
Address
Kita-15, Nishi-7, Kita-ku, Sapporo
TEL
011-706-9074
Homepage URL
Sponsor or person
Institute
Department of Breast and Endocrine Surgery, Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Health Labour Sciences Research Grant, etc.
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
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
北海道大学病院（北海道）/Hokkaido University Hospital(Hokkaido)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 03 | Month | 15 | 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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 01 | Month | 11 | 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 | 14 | Day |
Last modified on
| 2015 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008860
