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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004482
Receipt No. R000005362
Scientific Title Phase II Study of Adoptive Immunotherapy Comprising 2-Methyl-3-Butenyl-1-Pyrophosphate-Stimulated Gamma Delta T Cells, Teceleukin, and Zoledronic acid in Patients With Stage IV Renal Cell Carcinoma
Date of disclosure of the study information 2011/01/15
Last modified on 2014/06/23

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Basic information
Public title Phase II Study of Adoptive Immunotherapy Comprising 2-Methyl-3-Butenyl-1-Pyrophosphate-Stimulated Gamma Delta T Cells, Teceleukin, and Zoledronic acid in Patients With Stage IV Renal Cell Carcinoma
Acronym Phase II Study of Adoptive Immunotherapy Comprising 2-Methyl-3-Butenyl-1-Pyrophosphate-Stimulated Gamma Delta T Cells, Teceleukin, and Zoledronic acid in Patients With Stage IV Renal Cell Carcinoma
Scientific Title Phase II Study of Adoptive Immunotherapy Comprising 2-Methyl-3-Butenyl-1-Pyrophosphate-Stimulated Gamma Delta T Cells, Teceleukin, and Zoledronic acid in Patients With Stage IV Renal Cell Carcinoma
Scientific Title:Acronym Phase II Study of Adoptive Immunotherapy Comprising 2-Methyl-3-Butenyl-1-Pyrophosphate-Stimulated Gamma Delta T Cells, Teceleukin, and Zoledronic acid in Patients With Stage IV Renal Cell Carcinoma
Region
Japan

Condition
Condition Cytokine refractory Renal cell carcinoma
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Determine the efficacy and safety of adoptive immunotherapy comprising 2-methyl-3-butenyl-1-pyrophosphate-stimulated gamma delta T cells, zoledronic acid, and Teceleukin after nephrectomy in patients with cytokine refractory stage IV renal cell carcinoma.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Disease control rate:
The best overall responses is defined by the RECIST criteria. The target lesions were scanned using helical CT at lease 6 weeks interval during the clinical trial. The disease control rate was determined the proportion of CR+PR+SD.
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
Medicine
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 days. Patients then receive the expanded Gamma Delta T cells, teceleukin, and zoledronic acid every 3 weeks for up to 1 year.
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) Patients with histologically confirmed renal cell carcinoma who had undergone nephrectomy
2) Patients with Stage IV (any T, any N, M1)
3) Patients who received cytokine therapy resulted in failure and without molecular target drugs
4) Patients who had evaluable metastasis on CT three months before the start of treatment, whose tumor doubling time before treatment was evaluable and no indication of resection.
5) ECOG performance status 0-1 and age between 20 to 80-years old.
6) Life expectancy >= 6 months
7) Leukocyte count >=3,000/mm*3
ANC >= 1,500/mm*3
Platelet count >=100,000/mm*3
Serum bilirubin >= 1.5 mg/dL
AST/ALT >= 2.5 times normal
Serum creatinine >= 1.7 mg/dL
LDH>= 1.5 times normal
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
2) No brain metastasis, 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 35

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 03-3353-8111
Email annaka@kc.twmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirohito Kobayashi
Organization Tokyo Women's Medical University
Division name Department of Urology
Zip code
Address 8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL +81-3-3353-8111
Homepage URL
Email hirohitokobayashi-jua@umin.ac.jp

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 01 Month 15 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
2010 Year 10 Month 25 Day
Date of IRB
Anticipated trial start date
2010 Year 12 Month 01 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
2010 Year 10 Month 30 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=R000005362

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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