Pilot Study of a Double Isolation Perfusion Schedule Using Melphalan Alone for Intransit Melanoma… (NCT00001577) | Clinical Trial Compass
CompletedPhase 1
Pilot Study of a Double Isolation Perfusion Schedule Using Melphalan Alone for Intransit Melanoma or Unresectable Sarcoma of the Extremity
United States30 participantsStarted 1997-06
Plain-language summary
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.
Who can participate
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
Histologically confirmed unresectable sarcoma or intransit melanoma of the upper or lower extremity.
Extremity sarcoma with no local resection option and would require amputation based upon abutment or proximity of the tumor to major neurovascular structures or bone or joint structures.
MELANOMA PATIENTS:
Must have history of two or more satellite intransit metastases of which one may be excised for diagnosis with the exception of patients with a single, large, deep, locally recurrent tumor or metastatic tumor (greater than 5 cm) that precludes an excision with primary closure. Stage IV melanoma must have a significant component (greater than 90%) of disease distal to the apex of the femoral triangle in the lower limb or distal to the insertion of the deltoid in the upper limb.
Must have evaluable disease in the extremity. Melanoma must have dermal or subcutaneous lesion that can be measure directly in two diameters to assess tumor burden. Sarcoma must have either cutaneous lesions amenable to direct measurement or deeper lesions that can be measured on CT or MRI scans.
PRIOR/CONCURRENT THERAPY:
At least 2 months since any regional therapy to the affected extremity.
BIOLOGIC THERAPY: At least 1 month since Biologic Therapy.
CHEMOTHERAPY: At least 1 month since chemotherapy.
ENDOCRINE THERAPY: Not specified.
RADIOTHERAPY: At least 1 month since radiotherapy.
SURGERY: Not specified.
PATIENT CHARACTERISTICS:
AGE: 18 and over.
PERFORMANCE S…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.