Pilot Study of a Double Isolation Perfusion Schedule Using Melphalan Alone for Intransit Melanoma or Unresectable Sarcoma of the Extremity
|ClinicalTrials.gov Identifier: NCT00001577|
Recruitment Status : Completed
First Posted : December 10, 2002
Last Update Posted : March 4, 2008
Hyperthermic isolated limb perfusion with melphalan alone is administered as a double perfusion schedule.
These two isolates limb perfusions with melphalan are treated 3-6 weeks apart. After perfusion is established, the leak rate has been determined to be acceptable, and tissue temperatures are 38 degrees Celsius, then the melphalan is administered by slow injection into an arterial line over approximately 5 minutes. The perfusion with melphalan will then continue for 60 minutes, after which the extremity is flushed out with a total of 3 liters of fluid consisting initially of a saline solution. The dose of melphalan for the second perfusion will be increased.
An attempt to resect the residual lesion between 6-12 weeks after the second
interval perfusion may be made.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma Sarcoma||Procedure: double isolated limb perfusion with melphalan alone||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||30 participants|
|Official Title:||Pilot Study of a Double Isolation Perfusion Schedule Using Melphalan Alone for Intransit Melanoma or Unresectable Sarcoma of the Extremity|
|Study Start Date :||June 1997|
|Study Completion Date :||March 2000|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001577
|United States, Maryland|
|National Cancer Institute (NCI)|
|Bethesda, Maryland, United States, 20892|