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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000030143
Receipt No. R000034209
Scientific Title Phase 1/2 study of adoptive cell therapy using cultured tumor infiltrating lymphocytes with lympho-depleting non-myeloablative preconditioning for patients with advanced melanoma
Date of disclosure of the study information 2017/11/30
Last modified on 2018/08/09

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Basic information
Public title Phase 1/2 study of adoptive cell therapy using cultured tumor infiltrating lymphocytes with lympho-depleting non-myeloablative preconditioning for patients with advanced melanoma
Acronym MM-TIL-P1/2
Scientific Title Phase 1/2 study of adoptive cell therapy using cultured tumor infiltrating lymphocytes with lympho-depleting non-myeloablative preconditioning for patients with advanced melanoma
Scientific Title:Acronym MM-TIL-P1/2
Region
Japan

Condition
Condition Advanced malignant melanoma
Classification by specialty
Dermatology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluate the safety and efficacy of young tumor infiltrating lymphocytes ( young TIL) -adoptive cell therapy (ACT) with low dose IL-2 following a non-myeloablative chemotherapy preparative regimen in unresectable/metastatic malignant melanoma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Overall response rate, Safety
Key secondary outcomes Duration response, Duration of stable disease, Progression-free survival, Overall survival

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 Metastasectomy (day-35)
Non-myeloablative lymphocyte depleting preparative regimen (day-7~-3)
Transfer cultured tumor infiltrating lymphocytes (day0)
Low-dose interleukin-2(72,000IU/kg, q8hr) (day0~2, maximum 5 times)
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) Have histopathologically confirmed malignant melanoma.
2) Have unresectable stage 3 or 4 melanoma that are resistant to existing therapy.
3) Have the presence of measurable lesion. And also have at least one resectable lesion greater than 1 cm in diameter, that only needs 1-2 weeks hospital stay for resection)
4) Be male or female subjects, greater than or equal to 20 years of age and younger than or equal to 65 years of age.
5) Life expectancy of greater than three months.
6) Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 1.
7) Major organ function (bone marrow, liver, kidney etc.) ;
a) Leukocyte count >=3,000/mm3
b) Number of neutrophils >=1,000/mm3
c) Number of platelets >=100,000/mm3
d) Hemoglobin >=8.0g/dL
e) AST and ALT <=150IU/L
f) Total bilirubin <=3.0mg/dL
g) Creatinine clearance >=30mL/min/1.73m2
8) Have already stopped prior chemotherapy and recovered enough to receive the preparative regimen.
9) Agreed to use an adequate method of contraception within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment.
10) Able to understand and sign the Informed Consent Document.
Key exclusion criteria 1) Have experienced non-myeloablative lymphocyte depleting preparative regimen or myeloablative lymphocyte depleting preparative regimen.
2) Have central nervous system infiltration that causes symptoms.
3) Subjects with intraocular melanoma.
4) Women who are pregnant or breastfeeding.
5) Subjects who take immunosuppressant drugs or adrenocortical steroid*.
(*Excluding subjects who had adrenal insufficiency due to anti-PD1 or anti-CTLA4 antibodies therapy, which need steroid replacement dose)
6) Have active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system.
7) Have active other multiple primary malignancies.
8) Have active autoimmune disease.
9) Have a history of severe allergy to cyclophosphamide, fludarabine and IL-2.
10) Left ventricular ejection fraction (LVEF) <=50%
11) Forced expiratory volume in 1 second (FEV1.0%)<=60%
12) Has known history of HBV, HCV, HTLV-1, HIV.
13) Be determined to be ineligible by doctors.
Target sample size 14

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeru Funakoshi
Organization Keio University School of Medicine
Division name Department of Dermatology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL +81-3-5363-3823
Email takeruf@a8.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Maki Ishii
Organization Keio University School of Medicine
Division name Department of Dermatology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL +81-3-5363-3823
Homepage URL
Email maki-ishii@keio.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization Keio University School of Medicine
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
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

Other administrative information
Date of disclosure of the study information
2017 Year 11 Month 30 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 Terminated
Date of protocol fixation
2017 Year 11 Month 28 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 11 Month 28 Day
Last modified on
2018 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034209

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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