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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011431
Receipt No. R000013361
Scientific Title A feasibility Study Using Short-Term Cultured Anti-Tumor Autologous Lymphocytes Following a Lymphocyte Depleting Regimen in Metastatic Melanoma.
Date of disclosure of the study information 2013/08/15
Last modified on 2019/01/26

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Basic information
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
Condition Metastatic melanoma
Classification by specialty
Dermatology
Classification by malignancy Malignancy
Genomic information NO

Objectives
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

Assessment
Primary outcomes feasibility
Key secondary outcomes safety

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 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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Keio University, School of Medicine
Institute
Department

Funding Source
Organization AMED
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 慶應義塾大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 15 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 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
Other related information

Management information
Registered date
2013 Year 08 Month 08 Day
Last modified on
2019 Year 01 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013361

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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