Isolated Limb Perfusion of Melphalan for Melanoma and Sarcoma Treatment
Status:
Unknown status
Trial end date:
2020-07-01
Target enrollment:
Participant gender:
Summary
In-transit metastases occur in approximately 3% of melanoma patients, can be very symptomatic
and the survival in this group may be prolonged. In-transit melanoma metastases are often
confined to a limb. In this circumstance, treatment by isolated limb perfusion or isolated
limb infusion can be a remarkably effective regional treatment option. Isolated limb infusion
(ILI) was introduced in 1992 and is a technique used to deliver regional chemotherapy to
treat advanced melanoma confined to a limb. Regional chemotherapy with melphalan delivered by
isolated limb perfusion (ILP) or ILI are effective treatment options for in-transit melanoma
and are generally well tolerated.
ILI is a less invasive and simpler alternative to ILP. Complete response rates are 45- 69%
for ILP and 23-44% for ILI. The limb is often warmed to lower temperatures in ILI compared to
ILP and the limb becomes progressively more hypoxic and acidotic during ILI, each of these
parameters potentially having an effect on outcome. ILP & ILI are used primarily as
palliative options when excision of in-transit metastases is unfeasible but can be used as an
adjunctive procedure to surgery, for other tumour types such as merkel cell carcinoma, and
can be repeated if indicated. For ILI correction of melphalan dose for ideal body weight has
been shown to substantially decrease the rates of severe local toxicity while maintaining
complete response rates, but overall response rate is reduced.
Response to ILI, moreover, is different in upper and lower limbs. ILI for Upper limbs disease
is associated with similar complete response rates but lower toxicity than ILI for Lower
limbs E disease and with different physiologic sequelae despite comparable methods. The Upper
limbs appears relatively resistant to toxic effects of melphalan-based ILI as currently
performed, which suggests a potential for further optimization of drug dosing for Upper limbs
ILI.
Regional therapy is an excellent therapeutic modality for disease limited to a limb and
furthermore serves as an excellent model for scientific investigation, both clinical and
translational. In this study we want to collect data on isolated limb infusion of
chemotherapy to monitor efficacy and tolerability in patients with melanoma metastases of the
arm or leg that cannot be removed by surgery.