UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016793 |
|---|---|
| Receipt number | R000018768 |
| Scientific Title | A Pilot Study of Adoptive Immunotherapy Comprising 2-Methyl-3-Butenyl-1-Pyrophosphate-Stimulated Gamma Delta T Cells in Patients With advanced Renal Cell Carcinoma |
| Date of disclosure of the study information | 2015/03/13 |
| Last modified on | 2022/03/28 10:46:38 |
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Basic information
Public title
A Pilot Study of Adoptive Immunotherapy Comprising 2-Methyl-3-Butenyl-1-Pyrophosphate-Stimulated Gamma Delta T Cells in Patients With advanced Renal Cell Carcinoma
Acronym
A Pilot Study of Adoptive Immunotherapy Comprising 2-Methyl-3-Butenyl-1-Pyrophosphate-Stimulated Gamma Delta T Cells in Patients With advanced Renal Cell Carcinoma
Scientific Title
A Pilot Study of Adoptive Immunotherapy Comprising 2-Methyl-3-Butenyl-1-Pyrophosphate-Stimulated Gamma Delta T Cells in Patients With advanced Renal Cell Carcinoma
Scientific Title:Acronym
A Pilot Study of Adoptive Immunotherapy Comprising 2-Methyl-3-Butenyl-1-Pyrophosphate-Stimulated Gamma Delta T Cells in Patients With advanced Renal Cell Carcinoma
Region
| Japan |
Condition
Condition
advanced Renal cell carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Determine the factors of effective cases of adoptive immunotherapy comprising 2-methyl-3-butenyl-1-pyrophosphate-stimulated gamma delta T cells with advanced renal cell carcinoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To determine the factors of effective cases
To analyze the factors of the patients who achieved CR, PR or SD by RECIST criteria
Key secondary outcomes
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
| Other |
Interventions/Control_1
Patients undergo leukapheresis for the harvest of peripheral blood mononuclear cells (PBMCs). PBMCs are stimulated with 2-methyl-3-butenyl-1-pyrophosphate and aldesleukin for 11 to 14 days. Patients then receive the expanded Gamma Delta T cells every 3 to 4 weeks.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients with Stage IV (any T, any N, M1) or local advanced or inoperative RCC
2)Patients who received standard therapy resulted in failure or were not acceptability to molecular target drugs
3)ECOG performance status 0-1
4)Age over 20-years old.
5)Leukocyte count; 2,000/uL;
ANC ; 1,200/uL;
Platelet count; 70,000/uL;
Serum bilirubin; 1.5 mg/dL
AST/ALT; 2.5 times normal
Serum creatinine; 1.7 mg/dL (exceptunder hemodialysis)
LDH; 1.5 times normal
PT/APTT/FDP;1.5 times the facilities standard value
8) Patients who voluntarily provided written consent to participate in this trial after having been thoroughly briefed and informed of its nature were eligible for enrollment.
Key exclusion criteria
No C-reactive protein with an infectious disease that requires medication, No active infection with hepatitis virus or HIV, No poorly controlled DM or heart failure or arrhythmia, No autoimmune disease and interstitial pneumonia, No other malignancy, No bone of organ transplant recipient, Not pregnant nor nursing, No mental disorder in spite of standard therapy
3) Other patients judged to be ineligible by the attending investigators were also excluded from the study
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kazunari |
| Middle name | |
| Last name | Tanabe |
Organization
Tokyo Women's Medical University
Division name
Department of Urology
Zip code
162-8666
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan
TEL
+81-3-3353-8111
k-tanabe@k3.dion.ne.jp
Public contact
Name of contact person
| 1st name | Hirohito |
| Middle name | |
| Last name | Kobayashi |
Organization
Tokyo Women's Medical University
Division name
Department of Urology
Zip code
162-8666
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japa
TEL
+81-3-3353-8111
Homepage URL
hirohitokobayashi-jua@umin.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Review Board of Tokyo Women's Medical University
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan
Tel
+81-3-3353-8111
krinri.bm@twmu.ac.jp
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
| 2015 | Year | 03 | Month | 13 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 10 | Month | 29 | Day |
Date of IRB
| 2014 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 13 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 13 | Day |
Last modified on
| 2022 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018768
