Melphalan With or Without Tumor Necrosis Factor in Treating Patients With Locally Advanced Melanoma of the Arm or Leg

Completed · Phase 3

Conditions studied: Recurrent Melanoma, Stage III Melanoma

In brief

Randomized phase III trial to compare the effectiveness of hyperthermic isolated limb perfusion of melphalan with or without tumor necrosis factor in treating patients who have locally advanced melanoma of the arm or leg. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Heating melphalan to several degrees above body temperature and infusing it only to the area around the tumor may kill more tumor cells. It is not yet known whether combining melphalan with tumor necrosis factor is more effective than melphalan alone in treating melanoma.

Key facts

Study ID

NCT00003789

Run by

National Cancer Institute (NCI)

People needed

216

Starts

1999-03-01

Last updated by the study team

2013-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically proven locally advanced melanoma of an extremity
• One or more evaluable in-transit metastases
• All disease within the perfusion field of the extremity (with no local resection options short of amputation)
• Disease outside of perfusion field (with no local resection options short of amputation) if all the following are true:
• High tumor burden (more than 10 lesions or any single lesion greater than 3 cm)
• Presence of pain, edema, skin breakdown, or decreased mobility
• Greater than 80% of known tumor is within extremity perfusion field
• Life expectancy more than 6 months
• No brain metastases
• At least 1 bidimensionally measurable lesion
• Patients who received prior prophylactic isolated limb perfusion (ILP) must have 1 of the following:
• Disease-free interval for at least 6 months after prior ILP with melphalan
• Disease-free interval for at least 3 months after prior ILP with an agent other than melphalan
• Patients who received prior therapeutic ILP must have 1 of the following:
• Partial response of at least 3 months duration after prior ILP with melphalan
• Stable response or disease progression after ILP without melphalan (performed at least 3 months prior to study)
• Performance status - ECOG 0-2
• Performance status - Zubrod 0-2
• See Disease Characteristics
• Platelet count at least 100,000/mm\^3
• WBC greater than 2,500/mm\^3
• Hemoglobin greater than 9 g/dL
• Bilirubin less than 1.25 times ULN
• AST and ALT less than 2 times ULN
• Alkaline phosphatase less than 2 times ULN

Where it is running

• American College of Surgeons Oncology Group — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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