title: Isolated limb infusion with melphalan and dactinomycin for regional melanoma and soft-tissue sarcoma of the extremity: final report of a phase II clinical trial.
abstract: Isolated limb infusion (ILI) is a minimally invasive technique of delivering regional chemotherapy in patients with advanced melanoma or soft-tissue sarcoma of the limb. We report the final results of the first clinical trial of ILI in North America (NCT00004250). Eligible patients had recurrent melanoma or unresectable soft-tissue sarcoma of the limb. Angiographic catheters were positioned just above the knee or elbow of the extremity. General anesthesia was performed, a proximal tourniquet inflated, and a normothermic, low flow, hypoxic infusion of melphalan and dactinomycin circulated through the involved limb for 20 min. Tumor response and morbidity were assessed using standard criteria. Thirty-seven patients were accrued to the trial and 44 ILIs were performed (eight patients had two ILIs); one patient was not treated. Of the 32 evaluable patients, 17 (53%) had a significant response at 3 months: 25% of patients had a complete response and 28% of patients had a partial response. The median duration of complete response was 1 year (5-32 months). Morbidity was acceptable, with peak erythema, edema, and pain experienced at 2 weeks and considered 'moderate' in most patients. No patients developed compartment syndrome or required amputation because of ILI. ILI is well tolerated. More than half of the treated patients experienced a complete or partial response.
authors.affiliation: Department of Surgery, Memorial Sloan-Kettering Cancer Center, New York 10065, USA. bradym@mskcc.org
authors.forename: Mary S
authors.initials: MS
authors.lastname: Brady
authors.forename: Karen
authors.initials: K
authors.lastname: Brown
authors.forename: Ami
authors.initials: A
authors.lastname: Patel
authors.forename: Charles
authors.initials: C
authors.lastname: Fisher
authors.forename: Will
authors.initials: W
authors.lastname: Marx
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000768:Anesthesia, General; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000188:drug therapy* / Q000556:secondary; D001916:Brachial Artery; D002406:Catheterization, Peripheral; D010478:Chemotherapy, Cancer, Regional Perfusion / Q000009:adverse effects; D003609:Dactinomycin / Q000008:administration & dosage; D005121:Extremities; D005260:Female; D006801:Humans; D007261:Infusions, Intra-Arterial; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000556:secondary; D008558:Melphalan / Q000008:administration & dosage; D008875:Middle Aged; D011150:Popliteal Artery; D015641:Radiography, Interventional; D012074:Remission Induction; D012509:Sarcoma / Q000188:drug therapy*
chemical_list: D003609:Dactinomycin; D008558:Melphalan