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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000030321
Receipt No. R000018732
Scientific Title Analysis of Cyclophosphamide and interleukin-2 therapy for advanced renal cell carcinoma
Date of disclosure of the study information 2017/12/08
Last modified on 2017/12/08

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Basic information
Public title Analysis of Cyclophosphamide and interleukin-2 therapy for advanced renal cell carcinoma
Acronym Cyclophosphamide and interleukin-2 therapy
Scientific Title Analysis of Cyclophosphamide and interleukin-2 therapy for advanced renal cell carcinoma
Scientific Title:Acronym Cyclophosphamide and interleukin-2 therapy
Region
Japan

Condition
Condition renal cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Investigation of tumor effect of salvage therapy by cytokine therapy (therapy of Interleukin 2 (IL - 2) after Cyclophosphamide precedent) considering regulatory T cells for progressive renal cell carcinoma cases after molecular targeted drug treatment and peripheral blood lymphocyte - In particular, we analyze the relationship between Natural Killer cell (NK cell) acting on tumor suppression, CD8 positive T cell and regulatory T cell suppressing activity against CD8 positive T cell.
Basic objectives2 Others
Basic objectives -Others Investigation of antitumor effect of rescue therapy by cytokine therapy (therapy of Interleukin 2 (IL-2) after Cyclophosphamide precedent) considering regulatory T cells for progressive renal cell carcinoma cases after molecular targeted drug treatment and peripheral blood lymphocytes In particular, we analyze the relationship between Natural Killer cell (NK cell) which acts on tumor suppression, CD8 positive T cell and regulatory T cell which suppresses activity against CD8 positive T cell.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Response efficiency in the therapy of IL-2 after preceding Cyclophosphamide
Key secondary outcomes 1) progression-free survival in the therapy of IL-2 after preceding Cyclophosphamide
(Progression-free Survival, PFS)
2) Safety in the therapy of IL-2 after preceding Cyclophosphamide
3) On the change of various lymphocytes of peripheral blood

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
Interventions/Control_1 In the first week at hospitalization I intravenously inject Cyclophosphamide 300 mg / m 2 on day 1.
On day 2-5, infusion of 700 thousand units of IL-2 in 1 or 2 divided doses a day.
On the 2nd to 4th day intravenous infusion of IL - 2 700 thousand units intravenously in 1 to 2 times a day on the 1 st - 5 th day.
After that, we will shift to outpatient department, 28 days as 1 cycle, 300 mg / m 2 of Cyclophosphamide will be administered on the 1st day, and IL-2 will be administered 1 to 3 times per week outpatient.
Depending on the condition of the patient, the attending physician can appropriately reduce the dosage of IL-2.
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 who used molecularly targeted drugs for curative resection or metastatic renal cell carcinoma
(2) Patients with one or more measurable lesions according to RECIST v.1.1
(3) Patients over 20 years old and under 80
(4) Patients with ECOG Performance Status (PS) 0-1
(5) Patients with appropriate bone marrow function, liver function
Key exclusion criteria 1) Patients with a history of hypersensitivity to Cyclophosphamide and IL-2
2) Pregnant women, lactating women, pregnant women, lactating women, patients with a plan to go out
3) Patients receiving adrenocortical hormone drug and pentostatin
4) Patients with metastatic lesions in the brain
5) Patients who are deemed inappropriate for the subject doctor in this clinical trial
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Tamada
Organization Osaka City University
Division name Urology
Zip code
Address Osaka city, abeno-ku, asahimachi, 1-4-3
TEL 0666453857
Email s-tamada@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Tamada
Organization Osaka City University
Division name Urology
Zip code
Address Osaka city, abeno-ku, asahimachi, 1-4-3
TEL 0666453857
Homepage URL
Email s-tamada@med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University
Institute
Department

Funding Source
Organization none
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
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
2017 Year 12 Month 08 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
2015 Year 04 Month 21 Day
Date of IRB
Anticipated trial start date
2015 Year 05 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
2017 Year 12 Month 08 Day
Last modified on
2017 Year 12 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018732

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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