UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003489 |
|---|---|
| Receipt number | R000004208 |
| Scientific Title | A phase I clinical study of cancer vaccine with MAGE-A4/Survivin helper peptide for patients with advanced cancers expressing MAGE-A4 or Survivin antigen |
| Date of disclosure of the study information | 2010/04/19 |
| Last modified on | 2011/11/18 11:28:02 |
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Basic information
Public title
A phase I clinical study of cancer vaccine with MAGE-A4/Survivin helper peptide for patients with advanced cancers expressing MAGE-A4 or Survivin antigen
Acronym
Cancer vaccine study with MAGE-A4/Survivin helper peptide
Scientific Title
A phase I clinical study of cancer vaccine with MAGE-A4/Survivin helper peptide for patients with advanced cancers expressing MAGE-A4 or Survivin antigen
Scientific Title:Acronym
Cancer vaccine study with MAGE-A4/Survivin helper peptide
Region
| Japan |
Condition
Condition
MAGE-A4- or Survivin-expressing refractory cancer patients (non origin-limited) or patients who refuse standard cancer therapy
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Pneumology |
| Hematology and clinical oncology | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Breast surgery | Obstetrics and Gynecology | Oto-rhino-laryngology |
| Urology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate adverse events after repeated doses of MAGE-A4- or Survivin-helper peptide vaccine for patients with advanced cancers expressing MAGE-A4 or Survivin antigen
Basic objectives2
Others
Basic objectives -Others
To evaluate MAGE-A4 or Survivin specific immune responses and tumor responses after MAGE-A4 or Survivin helper peptide vaccin
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Safety: maximum tolerated dose, dose-limiting toxicity, profiles of adverse events evaluated by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Scale.
Key secondary outcomes
Efficacy: MAGE-A4 or Survivin-specific immune responses (Antibody production, Induction of antigen specific CD4+T and CD8+T cells), evaluated by ELISA or ELISPOT, and tumor responses, assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Vaccine |
Interventions/Control_1
Subcutaneous or peritumoral injection of MAGE-A4- or Survivin-hepler pepitde (1 mg) vaccine, mixed with Montanide and OK432 (Picibanil; 0.2 KE), at every two weeks, repeated 4 times
Interventions/Control_2
Subcutaneous or peritumoral injection of MAGE-A4- or Survivin-hepler pepitde (10 mg) vaccine, mixed with Montanide and OK432 (Picibanil; 0.2 KE), at every two weeks, repeated 4 times
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
1) Patients with histologically-confirmed malignant tumor, therapy-resistant cancer including chemotherapy and radio therapy, with clinical stage 3 or 4, recurrent cancer, or advanced cancer patients who refuse the standard therapy
2) Performance status (ECOG) 0 to 2
3) Aged twenty or more
4) At least three-month life expectancy
5) Normal bone-marrow and kidney function, meeting the criteria below;
Neutrophil cells>1500/mL
Lymphocytes>500/mL
Platelets>100000/mL
Hemoglobin>8.0 g/dL
Serum bilirubin<2 mg/dL
Serum creatinine<2.0 mg/dL (<2.5 mg/dL in Kidney cancer)
6) PCR/ IHC-confirmed MAGA-A4 or Survivin expressing tumor cells
7) Positive for HLA-DPB1*0501, HLA-DRB1*1403, HLA-DRB1*1501, or HLA-DRB1*1502 in MAGE-A4 helper peptide vaccine.
Positive for HLA-DRB1*0101, HLA-DR53, HLA-DQB1*0601 in Survivin helper peptide vaccine.
8) Having written informed consent
Key exclusion criteria
1) Pregnant women or refuse anticonception during the study (both sexes)
2) Lactating women
3) Severe bleeding disorders, meeting the criteria below;
PT<50%
APTT>60sec
Fbg<100mg/dl
FDP>20mg/ml
4) Active infection (HIV, HBV or HCV etc.)
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) Patient with impaired mental status in the study.
9) Inappropriate for study entry judged by an attending physician
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Todo Satoru |
Organization
Hokkaido University Graduated School of Medicine
Division name
Department of General Surgery
Zip code
Address
Kita-15, Nishi-7, Kita-ku, Sapporo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Togashi Yuji |
Organization
Bioimmulance Co. Ltd.
Division name
Bureau of MAGE-A4/Survivin peptide vaccine clinical study
Zip code
Address
KitaBusiness Spring 108/109
TEL
050-3359-8320
Homepage URL
ytogashi@bioimmulance.com
Sponsor or person
Institute
Department of General Surgery, Hokkaido University Graduated School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of General Surgery, Hokkaido University Graduated School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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/Hokkaido University Hospital
札幌北楡病院/Sapporo HOKUYU Hospital
東京慈恵会医科大学附属柏病院消化器・肝臓内科/ Department of Internal Medicine, The Jikei University School of Medicine
東海大学医学部付属病院/Tokai University School of Medicine
近畿大学医学部附属病院外科/Department of Surgery, Kinki University School of Medicine
愛媛大学医学部附属病院第１内科/Department of Bioregulatory Medicine, Ehime University Graduate School of Medicine
産業医科大学病院皮膚科/ Department of Dermatology, University of Occupational and Environmental Health School of Medicine
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 19 | 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
Completed
Date of protocol fixation
| 2009 | Year | 10 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 04 | Month | 14 | Day |
Last modified on
| 2011 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004208
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