Stage IV Melanoma Clinical Trial
Official title:
Isolated Limb Perfusion for Advanced Melanoma or Sarcoma Limited to Extremity With or Without Distant Metastases
This pilot clinical trial studies isolated limb perfusion with melphalan in treating patients with stage IIIB-IV melanoma or sarcoma. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Heating a chemotherapy solution and infusing it directly into the arteries around the tumor may kill more tumor cells.
PRIMARY OBJECTIVES:
I. This prospective trial will evaluate total response rate, including complete and partial
response, in patients with unresectable extremity melanoma (or other skin cancer including
but not limited to Merkel cell carcinoma) or soft tissue sarcoma treated with
hyperthermic-isolated limb perfusion (ILP) with melphalan.
SECONDARY OBJECTIVES:
I. To evaluate the technical parameters including achievement of regional hyperthermia,
arterial blood gas (ABG), tourniquet time, and their association with tumor response.
II. To evaluate time to recurrence and progression free survival (PFS) for patients with
advanced extremity melanoma or sarcoma who achieved complete response after treatment with
ILP with melphalan.
III. To evaluate overall survival rate and duration of survival for patients with advanced
melanoma or sarcoma limited to extremity undergoing ILP with melphalan.
IV. To assess quality of life (QOL) score for patients undergoing ILP with melphalan.
OUTLINE:
Patients undergo ILP with melphalan intravenously (IV) over 60 minutes.
After completion of study treatment, patients are followed up every 3 months for 2 years,
every 4 months for 1 year, and then periodically thereafter.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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