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
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
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
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
