Everolimus in Treating Patients With Stage IV Melanoma

Melanoma (Skin) Clinical Trial

Official title: Phase II Trial Of RAD-001 In Metastatic Malignant Melanoma

Status Completed

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy, such as everolimus, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus may also stop the growth of melanoma by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well everolimus works in treating patients with stage IV melanoma.

Clinical Trial Description

OBJECTIVES:

Primary

• Determine the median time to disease progression in patients with stage IV malignant melanoma treated with everolimus.

Secondary

• Determine the median overall survival of patients treated with this drug.

• Determine the clinical benefit rates (i.e., stable disease, partial remission, and complete response rates) in patients treated with this drug.

• Determine the toxicity profile of this drug in these patients.

• Determine changes in serum vascular endothelial growth factor levels in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral everolimus once daily for 8 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months until disease progression and then every 4 months for up to 5 years after registration. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

• NCT number: NCT00098553
• Study type: Interventional
• Source: Alliance for Clinical Trials in Oncology
• Status: Completed
• Phase: Phase 2
• Start date: April 2005
• Completion date: February 2010