NCT02507076

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

Isolated Limb Perfusion for Advanced Melanoma or Sarcoma Limited to Extremity With or Without Distant Metastases

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Albert Einstein College of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Basal Cell Carcinoma of the Skin
• Eccrine Carcinoma of the Skin
• Recurrent Adult Soft Tissue Sarcoma
• Recurrent Melanoma
• Recurrent Skin Cancer
• Squamous Cell Carcinoma of the Skin
• Stage III Adult Soft Tissue Sarcoma
• Stage IIIB Melanoma
• Stage IIIC Melanoma
• Stage IV Adult Soft Tissue Sarcoma
• Stage IV Melanoma

Interventions

Type	Name	Description
DRUG	isolated limb perfusion	Undergo ILP with melphalan
DRUG	melphalan	Undergo ILP with melphalan
PROCEDURE	quality-of-life assessment	Ancillary studies

Timeline

• Start date: 2012-04-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2015-07-23
• Last updated: 2015-07-23

Locations

1 site across 1 country: United States