UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase 1/2 Study of Hyperthermic Isolated Limb Perfusion with Melphalan for Patients with In-Transit Malignant Melanoma of the Extremity
Title of the study (Brief title)	MM_ILI
Region	Japan

Condition
Condition	Malignant Melanoma
Classification by specialty	Dermatology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Evaluate the safety and efficacy of the hyperthermic isolated limb perfusion using melphalan for unresectable in-transit Malignant Melanoma of the extremity.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	Overall Local Response Rate, Safety
Key secondary outcomes	Local Progression-free 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	Subjects will undergo a 30-min hyperthermic isolated limb perfusion with melphalan.
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1) Have histologically diagnosed with malignant melanoma. 2) Have unresectable in-transit cancer of primary extremity in stage 3b,3c,4. 3) Be male or female subjects, aged 20-79 years. 4) Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 1. 5) Have the presence of a measurable lesion in diseased limb (measurable lesions: CT scan slice thickness no greater than 5 mm, 6) Organ function (clinical laboratory value) The latest inspection value within 14 days before registration (same day as two weeks before the registration day is acceptable) satisfies all of the following. a) Leukocyte count >=2,000/mm3 b) Number of neutrophils >=1,000/mm3 c) Number of platelets >=100,000/mm3 d) Hemoglobin >=10g/dL e) Total bilirubin <=2.0mg/dL f) AST and ALT <=150IU/L g) Serum creatinine <=1.5 mg/dL
Key exclusion criteria	1) Have allergic histories of Melphalan or iodine contrast agent. 2) Have a possibility of pregnancy or cannot agree with contraception between the date of informed consent and 3 months after treatment. 3) Have poorly controlled diseases such as heart diseases and pulmonary diseases that can be at risk of general anesthesia and avascularization of limbs. 4) Have in-transit metastases tend to be relieved by pretreatment (if invariant, can be registered even if it is not in exacerbation trend). 5) Be unlikely to survive for 3 months from the original registration due to progress of other organ metastasis. 6) Have a pretreatment history of chemotherapy, immunity checkpoint inhibitor (anti-CTLA-4 antibody) except for anti-PD-1 antibody, interferon alpha-2b, interferon beta, other immunotherapy, and molecular targeted therapeutic agents within 4 weeks from the date of registration. 7) Within 8 weeks after initiation of anti-PD-1 antibody, or after 8 weeks and effective for treatment. 8) Have a limb ischemic disease (such as obstructive arteriosclerosis and Buerger's disease), severe vasculitis. Doctors judge (In principle ABI 0.9 or above is the qualification criteria, and if less than 0.9, assess the suitability by MR angiography/ CT angiography.) 9) Have a symptomatic brain metastasis. 10) Be determined to be ineligible by doctors.
Target sample size	14

Research contact person
Name of lead principal investigator	Takeru Funakoshi
Organization	Keio University School of Medicine
Division name	Department of Dermatology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo160-8582, Japan
TEL	81-3-5363-3823
Email	takeruf@keio.jp

Public contact
Name of contact person	Yoshio Nakamura
Organization	Keio University School of Medicine
Division name	Department of Dermatology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo160-8582, Japan
TEL	81-3-5363-3823
Homepage URL
Email	yn1109@keio.jp

Sponsor
Institute	Keio Univesity Hospital
Institute
Department

Funding Source
Organization	Keio University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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 10 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 11 Month 10 Day
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 11 Month 10 Day
Last modified on	2017 Year 11 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034170