UMIN-CTR Clinical Trial

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

renal cancer

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Osaka City University

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

12

Month

08

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2017

Year

12

Month

08

Day

Last modified on

2017

Year

12

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018732