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 Journal Article


Authors: Brady, M. S.; Brown, K.; Patel, A.; Fisher, C.; Marx, W.
Article 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. © 2009 Wolters Kluwer Health | Lippincott Williams & Wilkins.
Keywords: clinical article; treatment response; bone neoplasms; bone tumor; clinical trial; drug tolerability; cancer recurrence; cancer combination chemotherapy; side effect; antineoplastic agent; low drug dose; melanoma; metastasis; phase 2 clinical trial; nausea; antineoplastic combined chemotherapy protocols; morbidity; dexamethasone; melphalan; sarcoma; hypoxia; limb; peripheral edema; dactinomycin; heparin; papaverine; serotonin antagonist; amputation; compartment syndrome; compression; conventional angiography; drug infusion; elbow; erythema; general anesthesia; hyperpigmentation; isolated limb infusion; knee; knee function; limb pain; limb swelling; limb tumor; soft tissue sarcoma; tourniquet; brachial artery; catheterization; interventional radiology; intraarterial drug administration; popliteal artery; regional perfusion; remission; anesthesia, general; catheterization, peripheral; chemotherapy, cancer, regional perfusion; extremities; infusions, intra-arterial; radiography, interventional; remission induction
Journal Title: Melanoma Research
Volume: 19
Issue: 2
ISSN: 0960-8931
Publisher: Lippincott Williams & Wilkins  
Date Published: 2009-04-01
Start Page: 106
End Page: 111
Language: English
DOI: 10.1097/CMR.0b013e32832985e3
PUBMED: 19282789
PROVIDER: scopus
DOI/URL:
Notes: --- - "Cited By (since 1996): 1" - "Export Date: 30 November 2010" - "CODEN: MREEE" - "Source: Scopus"
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MSK Authors
  1. Karen T Brown
    178 Brown
  2. Mary Sue Brady
    201 Brady
  3. William L Marx
    15 Marx
  4. Ami Patel
    3 Patel
  5. Charles H Fisher
    8 Fisher