Isolated Limb Perfusion of Melphalan for Melanoma and Sarcoma Treatment

• Status: Unknown status
• Trial end date: 2020-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: International Group of Endovascular Oncology
• Treatments: Melphalan

Criteria

Inclusion Criteria:

1. Histologically proven primary or recurrent, regional melanoma or soft tissue sarcoma that is not amenable to surgical resection

2. Majority (greater than 95%) of disease must be distal to the apex of the femoral triangle in the lower limb and the deltoid insertion in the upper limb

3. Bidimensionally measurable disease in the extremity

4. Patients with disease beyond the limb are eligible if their extremity disease requires palliative treatment in the judgment of their physician

5. Age: more than 18

6. Karnofsky 70-100%

7. Life expectancy: At least 6 months

8. Hematopoietic: WBC at least 3,000/mm^3

9. Renal: Creatinine less than 2.0 mg/dL

10. At least 4 weeks since prior antitumor therapy and recovered

11. At least 2 weeks since prior antibiotics

Exclusion Criteria:

1. Signs or symptoms of vascular insufficiency (no history of claudication or other ischemic peripheral vascular disease)

2. pregnant or nursing

3. other concurrent serious illness

4. severe diabetes

5. prior extremity complications due to diabetes