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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000014435
Receipt No. R000016056
Scientific Title The feasibility of dendritic cell-based immunotherapy targeting synthesized long peptides containing helper epitopes for malignant tumor.
Date of disclosure of the study information 2014/06/30
Last modified on 2016/01/05

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Basic information
Public title The feasibility of dendritic cell-based immunotherapy targeting synthesized long peptides containing helper epitopes for malignant tumor.
Acronym The feasibility of dendritic cell-based immunotherapy targeting synthesized long peptides for malignant tumor.
Scientific Title The feasibility of dendritic cell-based immunotherapy targeting synthesized long peptides containing helper epitopes for malignant tumor.
Scientific Title:Acronym The feasibility of dendritic cell-based immunotherapy targeting synthesized long peptides for malignant tumor.
Region
Japan

Condition
Condition Malignant tumor
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Pneumology Endocrinology and Metabolism Hematology and clinical oncology
Nephrology Surgery in general Gastrointestinal surgery
Hepato-biliary-pancreatic surgery Vascular surgery Chest surgery
Endocrine surgery Breast surgery Obsterics and gynecology
Dermatology Orthopedics Urology
Oral surgery Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study aims to assess the feasibility and clinical effects of dendritic cell-based immunotherapy targeting synthesized long peptides containing helper epitopes for malignant tumor.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Safety:Adverse event
Key secondary outcomes Immunological responses
Overall survival
Response of tumor-related markers

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Vaccine Maneuver
Interventions/Control_1 All patients are intradermally injected 5-7 times with dendritic cells in close proximity to the axial and/or inguinal lymph nodes. Injections are repeated every 14-21 days.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria (1) Patient must suffice the following conditions:
1. Either in the post-curative operation status or post-complete remission status, but is predicted at a certain rate for recurrence, and desires to receive the dendritic cell-based immunotherapy as a recurrence prevention measure.
2. Standard therapies including surgery, chemotherapy, and radiation therapies are not effective, or for whom relapse is a strong concern during or after standard treatments. A patient with recurrent, unresectable, and metastatic disease is also included.
3. An expected prognosis of more than 4 months and likely to complete the 5 - 7 administrations.
(2) The expression of cancer antigen to be used in the therapy has been confirmed with tumor markers or through other methods, such as RT-PCR or immunostaining, or has a type of cancer already verified of its expression in literature.
(3) With a lesion on which assessment is available.
(4) Performance status is 0-1.
(5) Not under any other clinical studies or trials.
(6) No serious vital organ dysfunction, infections, hematological disorder, or bleeding tendency.
(7) Has a sufficiently functioning cardiovascular system to undergo apheresis to extract peripheral blood mononuclear cells.
(8) Fully understands the given explanations concerning this therapy and consents to it.
(9) Other inclusion criteria are as follows:
White blood cell count of 2,000 cells/uL or higher
Hemoglobin level of 9.0 g/dL or higher
Platelet count of 80,000 counts/uL or higher
Systolic blood pressure: 90 mm Hg or higher, and lower 180 mm Hg
Temperature: 38.0 degree or less
(10) HTLV-1-negative or HIV-negative.
Key exclusion criteria The patients have been
(1) Diagnosed or suspected of myelodysplastic syndrome (MDS).
(2) Suspected of other severe clinical conditions or abnormal laboratory values.
(3) Diagnosed or suspected of a mental disorder or mental symptoms.
(4) Suspected of immunodeficiency and/or infection.
Other exclusion criteria are as follows:
(5) Pregnant, lactating or suspected of pregnancy.
(6) Female patient rejecting to give consent to contraception during the therapy and for 70 days after the completion of the final administration.
(7) Taking in adrenocortical steroid (at the equivalent of 10mg predonine or prednisolone per day).
(8) Unsuitable for the therapy.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuji Morita
Organization Medical Corporation Isokai Seren Clinic Tokyo
Division name Oncology
Zip code
Address Shirokanedai bldg 2-10-2 Shirokanedai Minatoku Tokyo Japan
TEL 03-3449-6095
Email y.morita@serenclinic.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kentaro Kawakami
Organization Medical Corporation Isokai Seren Clinic Tokyo
Division name Purser department
Zip code
Address Shirokanedai bldg 2-10-2 Shirokanedai Minatoku Tokyo Japan
TEL 03-3449-6131
Homepage URL
Email k.kawakami@serenclinic.or.jp

Sponsor
Institute Medical Corporation Isokai Seren Clinic Tokyo
Institute
Department

Funding Source
Organization tella, Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2014 Year 06 Month 30 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 Terminated
Date of protocol fixation
2014 Year 06 Month 29 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 30 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
2014 Year 06 Month 30 Day
Last modified on
2016 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016056

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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