A Phase II Trial of Isolated Limb Infusion With Melphalan and Dactinomycin for Regional Melanoma and Soft Tissue Sarcoma of the Extremity
- Determine the efficacy of isolated limb infusion (ILI) with melphalan and dactinomycin
in patients with primary or recurrent, unresectable regional melanoma or soft tissue
sarcoma of the extremity.
- Determine the morbidity of patients treated with this regimen.
- Determine the expression of melanoma-associated antigens as well as cellular and
humoral immune responses to these antigens in patients with regional disease.
OUTLINE: Patients undergo fluoroscopic placement of angiographic arterial and venous
catheters into the appropriate extremity. After the limb is warmed, melphalan and
dactinomycin are rapidly infused into the isolated limb via the arterial catheter. Melphalan
and dactinomycin are then recirculated for 20 minutes. Patients with little or no response
at 8 weeks may receive up to 2 additional treatments at the discretion of the treating
Patients are followed at 1-2 weeks, 3-4 weeks, 6-8 weeks, and then every 3-6 months
thereafter as deemed necessary by the treating physician.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study within 3 years.
Masking: Open Label, Primary Purpose: Treatment
Mary S. Brady, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|