UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030143 |
|---|---|
| Receipt number | 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 07:59:56 |
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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
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
maki-ishii@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034209
