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Isolated Limb Perfusion With Melphalan in Treating Patients With Stage IIIB-IV Melanoma or Sarcoma

2015-07-24 12:38:22 | BioPortfolio

Summary

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.

Description

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Basal Cell Carcinoma of the Skin

Intervention

isolated limb perfusion, melphalan, quality-of-life assessment

Location

Albert Einstein College of Medicine
Bronx
New York
United States
10461

Status

Withdrawn

Source

Albert Einstein College of Medicine of Yeshiva University

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-07-24T12:38:22-0400

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