Pilot Study of a Double Isolation Perfusion Schedule Using Melphalan Alone for Intransit Melanoma or Unresectable Sarcoma of the Extremity
Patients with extremity melanoma (Stage IIIA, IIIAB or Stage IV disease who have bulky
symptomatic tumor located in the extremity) or patients with unresectable extremity sarcoma
will undergo a double isolated limb perfusion with melphalan alone separated by
approximately 4 to 6 weeks. The initial perfusion will be done with a melphalan dose of 6
mg/L limb volume and the interval perfusion with a dose of 9 mg/L limb volume. For patients
with extremity sarcoma the tumor will be excised if feasible using a limb sparing resection
between 6-12 weeks after the second perfusion. Technical feasibility of the double
perfusion schedule will be determined. Overall response, duration of response, patterns of
recurrence, and survival will be followed.
Interventional
Endpoint Classification: Safety Study, Primary Purpose: Treatment
United States: Federal Government
970131
NCT00001577
June 1997
March 2000
Name | Location |
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National Cancer Institute (NCI) | Bethesda, Maryland 20892 |