UMIN-CTR Clinical Trial

Public title

Phase I/IIa study of intravesical administration of 2-methyl-3-butenyl-1-pyrophosphate-stimulated gamma delta T cells in patients with non-invasive bladder cancer.

Acronym

Phase I/IIa study of intravesical administration of 2-methyl-3-butenyl-1-pyrophosphate-stimulated gamma delta T cells in patients with non-invasive bladder cancer.

Scientific Title

Phase I/IIa study of intravesical administration of 2-methyl-3-butenyl-1-pyrophosphate-stimulated gamma delta T cells in patients with non-invasive bladder cancer.

Scientific Title:Acronym

Phase I/IIa study of intravesical administration of 2-methyl-3-butenyl-1-pyrophosphate-stimulated gamma delta T cells in patients with non-invasive bladder cancer.

Region

Japan

Condition

Non-invasive bladder cancer

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Determine the safety and efficacy of intravesical administration of 2-methyl-3-butenyl-1-pyrophosphate-stimulated gamma delta T cells in patients with non-invasive bladder cancer before surgery.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Safety and efficacy:
Adverts events are accessed by CTCAE ver.4.0. Efficacy is accessed by cystoscopy examination and immunohistochemical staining of the bladder cancer.

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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 for 14 days. Patients then receive intravesical administration of the expanded Gamma Delta T cells for 4 times before the surgery.

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

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients with cystoscopic diagnosed as bladder cancer who is scheduled transurethral-resection of bladder tumor (TUR-BT).
2) Patients who is able to receive 4 times of intravesical administration of the expanded gamma delta T cells before the TUR-BT.
3) ECOG performance status 0-1 and age > 20-years old.
4) 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 ≤ 1.7 mg/dL
LDH ≤ 1.5 times normal
PT/APTT/FDP≤ 1.5 times normal
5) 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 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 and immunosuppressive drugs, 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
2) Other patients judged to be ineligible by the attending investigators were also excluded from the study

Target sample size

12

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

k-tanabe@k3.dion.ne.jp

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, 162-8666, Japan

TEL

03-3353-8111

Homepage URL

Email

Hirohitokobayashi-jua@umin.ac.jp

Institute

Tokyo Women's Medical University

Institute

Department

Personal name

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

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

2013

Year

07

Month

01

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

2013

Year

06

Month

12

Day

Date of IRB

Anticipated trial start date

2013

Year

07

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

2013

Year

06

Month

12

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=R000012809