UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006617 |
|---|---|
| Receipt number | R000007824 |
| Scientific Title | Phase I/IIa Study of Adoptive Immunotherapy Comprising 2-Methyl-3-Butenyl-1-Pyrophosphate-Stimulated Gamma Delta T Cells in Patients With PSA biochemical failure after radical prostatectomy. |
| Date of disclosure of the study information | 2011/10/28 |
| Last modified on | 2014/06/23 10:32:18 |
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Basic information
Public title
Phase I/IIa Study of Adoptive Immunotherapy Comprising 2-Methyl-3-Butenyl-1-Pyrophosphate-Stimulated Gamma Delta T Cells in Patients With PSA biochemical failure after radical prostatectomy.
Acronym
Phase I/IIa Study of Adoptive Immunotherapy Comprising 2-Methyl-3-Butenyl-1-Pyrophosphate-Stimulated Gamma Delta T Cells in Patients With PSA biochemical failure after radical prostatectomy.
Scientific Title
Phase I/IIa Study of Adoptive Immunotherapy Comprising 2-Methyl-3-Butenyl-1-Pyrophosphate-Stimulated Gamma Delta T Cells in Patients With PSA biochemical failure after radical prostatectomy.
Scientific Title:Acronym
Phase I/IIa Study of Adoptive Immunotherapy Comprising 2-Methyl-3-Butenyl-1-Pyrophosphate-Stimulated Gamma Delta T Cells in Patients With PSA biochemical failure after radical prostatectomy.
Region
| Japan |
Condition
Condition
PSA biochemical failure after radical prostatectomy
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Determine the safety and efficacy of adoptive immunotherapy comprising 2-methyl-3-butenyl-1-pyrophosphate-stimulated gamma delta T cells in patients with PSA biochemical failure after radical prostatectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety and efficacy:
Adverts events are accessed by CTCAE ver.4.0. Efficacy is accessed by prolongation of PSA doubling time.
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
Historical
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 14 days. Patients then receive the expanded Gamma Delta T cells every 3 weeks for 4 times.
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
Key inclusion criteria
1) Patients with histologically confirmed prostate carcinoma who had undergone radical prostatectomy
2) Patients with PSA biochemical failure and PSA<0.4ng/ml within 4 weeks before enrollment.
3) PSA doubling time is calculated and positive value before enrollment.
4) Patients who had no clinical recurrence and metastasis defined by CT and bone scintigraphy.
5) ECOG performance status 0-1 and age > 20-years old.
6) Leukocyte count ≥ 3,000/mm³
ANC ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Serum bilirubin ≤ 1.5 mg/dL
AST/ALT ≤ 2.5 times normal
Serum creatinine ≤ 1.5 mg/dL
LDH ≤ 1.5 times normal
Teststeron>150ng/dL
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
1) No current treatment with any anti-cancer drugs and androgen depletion therapy.
2) No hypercalcemia that require medication, No C-reactive protein with an infectious disease that requires medication, No active infection with hepatitis virus or HIV, No current treatment with steroids, 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.
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 | |
| Middle name | |
| Last name | Kazunari Tanabe |
Organization
Tokyo Women's Medical University
Division name
Department of Urology
Zip code
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tokyo Women's Medical University
Division name
Department of Urology
Zip code
Address
Hirohitokobayashi-jua@umin.ac.jp
TEL
Homepage URL
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding 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
| 2011 | Year | 10 | Month | 28 | 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
| 2011 | Year | 06 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 06 | Month | 23 | Day |
Date of closure to data entry
| 2014 | Year | 06 | Month | 23 | Day |
Date trial data considered complete
| 2014 | Year | 06 | Month | 23 | Day |
Date analysis concluded
| 2014 | Year | 06 | Month | 23 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 27 | Day |
Last modified on
| 2014 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007824
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