Sorafenib and Isolated Limb Infusion of Melphalan in Treating Patients With Stage III Melanoma of the Arm or Leg

Phase 1

Completed

• Conditions: Melanoma (Skin)
• Interventions: Drug: melphalan; Drug: sorafenib tosylate; Genetic: gene expression analysis; Genetic: protein expression analysis; Genetic: western blotting; Other: pharmacological study

• Registration Number: NCT00565968
• Lead Sponsor: Duke University

Brief Summary

RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. 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. Sorafenib may also make tumor cells more sensitive to melphalan. Giving sorafenib together with an isolated limb infusion of melphalan may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of sorafenib when given together with an isolated limb infusion of melphalan in treating patients with stage III melanoma of the arm or leg.

Detailed Description

OBJECTIVES:

Primary

* To determine the dose-limiting toxicities and maximum tolerate dose of systemic sorafenib tosylate in combination with regionally administered melphalan by isolated limb infusion in patients with stage IIIB or IIIC intransit extremity melanoma.

Secondary

* To characterize the safety and tolerability of this regimen in these patients.

* To assess the antitumor activity of this regimen, as evidenced by best overall response and duration of response, in these patients.

* To characterize the duration of progression-free survival of these patients.

* To characterize the pharmacokinetics of melphalan.

* To assess alterations in selected gene and protein expression profiles following treatment.

OUTLINE: This is a multicenter, dose-escalation study of sorafenib tosylate.

Patients receive oral sorafenib tosylate twice daily on days 1-14 and melphalan via isolated limb infusion into the upper or lower extremities on day 8.

Patients undergo tumor biopsies at baseline and in weeks 2 and 12 for gene expression analysis and western blot analysis. Patients also undergo blood sample collection periodically for pharmacokinetic analysis of melphalan.

After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 2 years.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-11-29
• Study First Submitted QC: 2007-11-29
• Study First Posted: 2007-11-30
• Primary Completion: 2009-08
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-05
• Last Update Posted: 2015-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sorafenib dose escalation	western blotting	-
Sorafenib dose escalation	sorafenib tosylate	-
Sorafenib dose escalation	gene expression analysis	-
Sorafenib dose escalation	protein expression analysis	-
Sorafenib dose escalation	pharmacological study	-
Sorafenib dose escalation	melphalan	-

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose	1 year

Secondary Outcome Measures

Name	Time	Method
Duration of progression-free survival	3 years
Tumor gene and protein expression profiles following treatment	3 years
Safety and tolerability	2 years
Antitumor activity, as evidenced by best overall response and duration of response	3 years
Pharmacokinetics of melphalan	3 years

Trial Locations

Locations (1)

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States