UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015233
Receipt number R000017288
Scientific Title Intraperitoneal injection of in vitro expanded Gamma Delta T cells together with zoledronate for the treatment of malignant ascites to ovarian cancer ; to evaluate the safety and efficacy. (A Phase 1/2a study)
Date of disclosure of the study information 2014/09/24
Last modified on 2020/04/09 10:47:01

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Basic information

Public title

Intraperitoneal injection of in vitro expanded Gamma Delta T cells together with zoledronate for the treatment of malignant ascites to ovarian cancer ; to evaluate the safety and efficacy. (A Phase 1/2a study)

Acronym

Intraperitoneal injection of in vitro expanded Gamma Delta T cells together with zoledronate for the treatment of malignant ascites to ovarian cancer ; to evaluate the safety and efficacy. (A Phase 1/2a study)

Scientific Title

Intraperitoneal injection of in vitro expanded Gamma Delta T cells together with zoledronate for the treatment of malignant ascites to ovarian cancer ; to evaluate the safety and efficacy. (A Phase 1/2a study)

Scientific Title:Acronym

Intraperitoneal injection of in vitro expanded Gamma Delta T cells together with zoledronate for the treatment of malignant ascites to ovarian cancer ; to evaluate the safety and efficacy. (A Phase 1/2a study)

Region

Japan


Condition

Condition

Ovarian cancer,tubal carcinoma, primary peritoneal cancer

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety and efficacy, intraperitoneal injection of in vitro expanded Gamma Delta T cells together with zoledronate for the treatment of malignant ascites to ovarian cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase I,II


Assessment

Primary outcomes

Safety of i.p. injection of autologous Gamma Delta T cells.

Key secondary outcomes

Puncture-free-survival,QOL and immunological proof-of-concept of antitumor activity.


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

Patients undergo leukapheresis for the harvest of peripheral blood mononuclear cells (PBMCs). PBMCs are stimulated with 2-methyl-3-butenyl-1-pyrophosphate and interleukin-2 and cultured for 14 days. Patients then receive the expanded Gamma Delta T cells with zoledronate intra peritoneal via a catheter.

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

Female

Key inclusion criteria

1)Aged=>20 years
2)Patients with histologically or cytologically proven ovarian cancer, tubal carcinoma or primary peritoneal cancer
3)Patients who havemalignant ascites
4)ECOG performance status 0-2
5)Leukocyte count => 3,000/mm3
ANC =>1,500/mm3
Platelet count =>100,000/mm3
Serum creatinine => 2.0 mg/dL
Serum bilirubin => 2.0 mg/dL
AST/ALT =>2.5 times normal
LDH => 1.5 times normal
PT/APTT => 1.5 times normal
6)Life expectancy =>4 months
7)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)Patients who positive for anti-adult T-cell leukemia-associated antigen or anti-human immunodeficiency virus antibody,or hepatitis.
2)Patients who have uncontrolled infection
3)Patients receiving immunodepressant
4)Patient who were pregnant or lactating
5)Other patients judged to be ineligible by the attending investigators

Target sample size

7


Research contact person

Name of lead principal investigator

1st name Hideo
Middle name
Last name Matsui

Organization

Tokyo Women's Medical University Hospital

Division name

Obstetrics and Gynecology

Zip code

162866

Address

8-1,Kawadacho,Shinjuku-ku,Tokyo-to

TEL

+81-3-3533-8111

Email

hmatsui@obgy.twmu.ac.jp


Public contact

Name of contact person

1st name Yuki
Middle name
Last name Abe

Organization

Tokyo Women's Medical University Hospital

Division name

Obstetrics and Gynecology

Zip code

1628666

Address

8-1,Kawadacho,Shinjuku-ku,Tokyo-to

TEL

+81-3-3533-8111

Homepage URL


Email

yuki_a925_thanks@yahoo.co.jp


Sponsor or person

Institute

Tokyo Women's Medical University Hospital

Institute

Department

Personal name



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

Review Board of the Tokyo Women's Medical University

Address

8-1,Kawadacho,Shinjuku-ku,Tokyo-to

Tel

+81-3-3353-8111

Email

krinri.bm@twmu.ac.jp


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

2014 Year 09 Month 24 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

Main results already published

Date of protocol fixation

2014 Year 09 Month 11 Day

Date of IRB

2014 Year 09 Month 11 Day

Anticipated trial start date

2014 Year 09 Month 24 Day

Last follow-up date

2017 Year 08 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 09 Month 24 Day

Last modified on

2020 Year 04 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017288


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name