UMIN-CTR Clinical Trial

Public title

A feasibility Study Using Short-Term Cultured Anti-Tumor Autologous Lymphocytes Following a Lymphocyte Depleting Regimen in Metastatic Melanoma.

Acronym

A feasibility Study Using Short-Term Cultured Anti-Tumor Autologous Lymphocytes Following a Lymphocyte Depleting Regimen in Metastatic Melanoma.

Scientific Title

A feasibility Study Using Short-Term Cultured Anti-Tumor Autologous Lymphocytes Following a Lymphocyte Depleting Regimen in Metastatic Melanoma.

Scientific Title:Acronym

A feasibility Study Using Short-Term Cultured Anti-Tumor Autologous Lymphocytes Following a Lymphocyte Depleting Regimen in Metastatic Melanoma.

Region

Japan

Condition

Metastatic melanoma

Classification by specialty

Dermatology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Evaluate the toxicity of autologous TIL cells infused after minimal in vitro culture in conjunction with low dose aldesleukin (IL-2) following a non-myeloablative lymphodepleting preparative regimen to mediate tumor regression in patient with metastatic melanoma.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase I

Primary outcomes

feasibility

Key secondary outcomes

safety

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

Tumor resection(day-28)
Non-myeloablative lymphocyte depleting preparative regimen(day-7~-3)
Transfer cultured tumor infiltrating lymphocytes(day0)
Low-dose interleukin-2(day0~4)

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

65

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) Pathologically confirmed metastatic melanoma.
2) Measurable metastatic melanoma with at least one lesion that is resectable for TIL generation.
3) Greater than or equal to 20 years of age and younger than or equal to 65 years of age.
4) Life expectancy of greater than three months.
5) Clinical performance status of ECOG 0 or 1.
6) Normal values for basic laboratory values
7) More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the preparative regimen, and patients' toxicities must have recovered to a grade 1 or less.
8) Able to understand and sign the Informed Consent Document.
9) Gain the cooperation of at least two family and/or friends on peripheral blood mononuclear cells apheresis.

Key exclusion criteria

1) Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
2) Men who plan to impregnate a woman
3) Active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system.
4) Patients who have active other primary malignancies
5) Patients who have severe psychiatric disease
6) History of severe immediate hypersensitivity reaction to any of the agents used in this study.
7) History of coronary revascularization or ischemic symptoms.
8) Carrier of HBV, HCV, HTLV-1, HIV and so on.
9)Patients who are judged inappropriate to be enrolled in this study by the doctor in charge.

Target sample size

6

Name of lead principal investigator

1st name
Middle name
Last name	Yutaka Kawakami

Organization

Keio University, School of Medicine

Division name

Division of Cellular Signaling for Advanced Medical Research

Zip code

Address

35 Shinanomachi, Shinjuku-ku, Tokyo, Japan

TEL

03-3353-1211

Email

yutakawa@z5.keio.jp

Name of contact person

1st name
Middle name
Last name	Takeru Funakoshi

Organization

Keio University, School of Medicine

Division name

Depertment of Dermatology

Zip code

Address

35 Shinanomachi, Shinjuku-ku, Tokyo, Japan

TEL

03-5363-3823

Homepage URL

Email

takeruf@a8.keio.jp

Institute

Keio University, School of Medicine

Institute

Department

Personal name

Organization

AMED

Organization

Division

Category of Funding Organization

Non profit foundation

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

慶應義塾大学病院（東京都）

Date of disclosure of the study information

2013

Year

08

Month

15

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

Completed

Date of protocol fixation

2015

Year

11

Month

24

Day

Date of IRB

Anticipated trial start date

2016

Year

01

Month

04

Day

Last follow-up date

2018

Year

08

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

08

Month

08

Day

Last modified on

2019

Year

01

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013361