A Randomized Phase III Trial of Hyperthermic Isolated Limb Perfusion With Melphalan, Tumor Necrosis Factor, and Interferon-Gamma in Patients With Locally Advanced Extremity Melanoma
Patients with locally advanced melanoma confined to an extremity (Stage IIIA or Stage IIIAB)
will be treated in a randomized Phase III study with hyperthermic isolated limb perfusion.
One arm of the study will be a standard 60 minute perfusion with melphalan as a single
agent. The second arm of the study will combine melphalan, tumor necrosis factor, and
interferon-gamma in the isolated limb perfusion reproducing a regimen shown to have 100%
response rates in a Phase II European trial. Patients will be followed for local response
rates, duration of response, treatment toxicity, and disease-free survival.
Endpoint Classification: Efficacy Study, Primary Purpose: Treatment
United States: Federal Government
|National Cancer Institute (NCI)||Bethesda, Maryland 20892|