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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000006617
Receipt No. 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

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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 &#8805; 3,000/mm&#179;
ANC &#8805; 1,500/mm&#179;
Platelet count &#8805; 100,000/mm&#179;
Serum bilirubin &#8804; 1.5 mg/dL
AST/ALT &#8804; 2.5 times normal
Serum creatinine &#8804; 1.5 mg/dL
LDH &#8804; 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
Email

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
Email

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007824

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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