UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014435 |
|---|---|
| Receipt number | 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 14:22:35 |
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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 | Obstetrics 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
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
k.kawakami@serenclinic.or.jp
Sponsor or person
Institute
Medical Corporation Isokai Seren Clinic Tokyo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016056
