UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004828
Receipt No. R000005747
Scientific Title A phase I clinical study of immune cell therapy with MAGE-A4- or Survivin-specific Th1 cells for patients with refractory virulent tumors
Date of disclosure of the study information 2011/01/07
Last modified on 2013/10/09

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A phase I clinical study of immune cell therapy with MAGE-A4- or Survivin-specific Th1 cells for patients with refractory virulent tumors
Acronym MAGE-A4/Survivin-specific Th1 cell therapy for cancer patients
Scientific Title A phase I clinical study of immune cell therapy with MAGE-A4- or Survivin-specific Th1 cells for patients with refractory virulent tumors
Scientific Title:Acronym MAGE-A4/Survivin-specific Th1 cell therapy for cancer patients
Region
Japan

Condition
Condition Refractory cancer patients (MAGE-A4- or Survivin-expressing, non origin-limited) or the patients who refuse standard cancer therapy
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Pneumology
Nephrology Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Chest surgery Breast surgery Obsterics and gynecology
Oto-rhino-laryngology Urology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate adverse events after repeated transfer of MAGE-A4- or Survivin-specific Th1 cells 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 transfer of MAGE-A4- or Survivin-specific Th1 cells
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes Safety: Dose limiting toxicity (DLT) and Type, frequency, and degree of adverse events (AE)
Key secondary outcomes Efficacy: MAGE-A4 or Survivin-antigen specific immune responses (antibody production, CD4+T and CD8+T cell responses) and antitumor action

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 3
Purpose of intervention Treatment
Type of intervention
Medicine Vaccine
Interventions/Control_1 Subcutaneous or peritumoral injection of MAGE-A4- or Survivin-specific Th1 cells (3x10^7cells), mixed with MAGE-A4- or Survivin-hepler pepitde (0.1 mg), at every two weeks, repeated 4 times
Interventions/Control_2 Subcutaneous or peritumoral injection of MAGE-A4- or Survivin-specific Th1 cells (10x10^7cells), mixed with MAGE-A4- or Survivin-hepler pepitde (0.1 mg), at every two weeks, repeated 4 times
Interventions/Control_3 Subcutaneous or peritumoral injection of MAGE-A4- or Survivin-specific Th1 cells (30x10^7cells), mixed with MAGE-A4- or Survivin-hepler pepitde (0.1 mg), at every two weeks, repeated 4 times
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) Aged twenty or more at the time of informed consent
2) Patients with histologically-confirmed malignant neoplasm
3) Therapy-resistant cancer including chemotherapy and radio therapy, with clinical stage III or IV, recurrent cancer or patients who refuse the standard therapy
4) Patients with histologically-confirmed carcinoma. Therapy-resistant cancer including chemotherapy and radio therapy, with clinical stage III or IV, recurrent cancer, or advanced cancer patients who refuse the standard therapy
5) Performance status (ECOG) 0 to 2
6) At least four-month life expectancy
7) Normal bone-marrow and kidney function, meeting the criteria below;
Neutrophil cells>1500/microL
Lymphocytes>500/microL
Platelets>100000/microL
Hemoglobin>8.0 g/dL
Serum bilirubin<2 mg/dL
Serum creatinine<2.0 mg/dL (<2.5 mg/dL in Kidney cancer)
8) PCR/ IHC-confirmed MAGA-A4 or Survivin expressing tumor cells
9) Positive for HLA-DPB1*0501, HLA-DRB1*1403, HLA-DRB1*1501, HLA-DRB1*1502, or HLA-DRB1*0101 in MAGE-A4-specific Th1 cell therapy.
Positive for HLA-DRB1*0101, HLA-DR53, HLA-DQB1*0601, or HLA-DPB1*0501 in Survivin-specific Th1 cell therapy
10) Patients having written informed consent by their free will after explanation of the present study
Key exclusion criteria 1) Patients with the previous enrollment to clinical trials of cancer immune therapy for MAGE-A4 in MAGE-A4-specific Th1 cell therapy.
2) Patients with the previous enrollment to clinical trials of cancer immune therapy for Survivin in Survivin-specific Th1 cell therapy.
3) Pregnant women or women refused anticonception during the study
4) Men refused anticonception during the study
5) Lactating women or women refused lactating during the study
6) Severe bleeding disorders, meeting the criteria below;
PT<50%
APTT>60sec
Fbg<100mg/dl
FDP>20mg/ml
Severe bleeding case judged by an attending physician at the diagnosis
7) Active infection (HIV, HBV or HCV etc.)
8) Severe heart disease (NYHA class 3 or 4)
9) Autoimmune disease (scleroderma, Sjogren's syndrome, idiopathic thrombocytopenic purpura, multiple sclerosis, rheumatoid arthritis etc.)
10) Systemic administration of corticosteroid or immunosuppresive drugs during the study (Except local administration, inhaled drugs, and antiphlogistic analgetics).
11) Patient with impaired mental status in the study.
12) Inappropriate for study entry judged by an attending physician
Target sample size 18

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
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 MAGE-A4/Survivin Th1 cell therapy clinical study
Zip code
Address Kita-15, Nishi-7, Kita-ku, Sapporo
TEL 011-706-9074
Homepage URL
Email

Sponsor
Institute Department of General Surgery, Hokkaido University Graduated School of Medicine
Institute
Department

Funding Source
Organization NEDO (New Energy and Industrial Technology Development Organization), etc
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor 1) Division of Immunoregulation, Institute for Genetic Medicine, Hokkaido University
2) Bioimmulance Co. Ltd
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/Hokkaido University Hospital

Other administrative information
Date of disclosure of the study information
2011 Year 01 Month 07 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
2010 Year 11 Month 11 Day
Date of IRB
Anticipated trial start date
2010 Year 12 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
2011 Year 01 Month 06 Day
Last modified on
2013 Year 10 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005747

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.