drugset / Trial / NCT00003789

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

NCT00003789

Phase 3 Completed 216 enrolled National Cancer Institute (NCI)
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
1999-03
Primary completion
2004-01
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Melphalan Small molecule Other
Subject tumor necrosis factor Protein / enzyme biologic Other

Indications