UMIN-CTR Clinical Trial

Public title

Phase 1/2 Study of Hyperthermic Isolated Limb Perfusion with Melphalan for Patients with In-Transit Malignant Melanoma of the Extremity

Acronym

MM_ILI

Scientific Title

Phase 1/2 Study of Hyperthermic Isolated Limb Perfusion with Melphalan for Patients with In-Transit Malignant Melanoma of the Extremity

Scientific Title:Acronym

MM_ILI

Region

Japan

Condition

Malignant Melanoma

Classification by specialty

Dermatology

Radiology

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

Overall Local Response Rate, Safety

Key secondary outcomes

Local Progression-free Survival

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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, Tokyo160-8582, Japan

TEL

81-3-5363-3823

Email

takeruf@keio.jp

Name of contact person

1st name
Middle name
Last name	Yoshio Nakamura

Organization

Keio University School of Medicine

Division name

Department of Dermatology

Zip code

Address

35 Shinanomachi, Shinjuku-ku, Tokyo160-8582, Japan

TEL

81-3-5363-3823

Homepage URL

Email

yn1109@keio.jp

Institute

Keio Univesity Hospital

Institute

Department

Personal name

Organization

Keio University Hospital

Organization

Division

Category of Funding Organization

Self funding

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

Date of disclosure of the study information

2017

Year

11

Month

10

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

Preinitiation

Date of protocol fixation

2017

Year

11

Month

10

Day

Date of IRB

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

Other related information

Registered date

2017

Year

11

Month

10

Day

Last modified on

2017

Year

11

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034170