Malignant Melanoma
Conditions
Interventions
Subjects will undergo a 30-min hyperthermic isolated limb perfusion with melphalan.
Sponsors
Keio Univesity Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Local Response Rate, Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Local Progression-free Survival | — |
Countries
Japan
Contacts
Public ContactYoshio Nakamura
Keio University School of Medicine Department of Dermatology
Outcome results
None listed