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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007507
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Department of Breast and Endocrine Surgery, Hokkaido University Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008860

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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