NCT00022464

CCI-779 in Treating Patients With Metastatic Melanoma

A Phase II Study Of CCI-779 (NSC 683864) In Metastatic Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of CCI-779 in treating patients who have metastatic melanoma.

Detailed description

OBJECTIVES: * Determine the anti-tumor activity of CCI-779, in terms of progression-free survival, in patients with metastatic melanoma. * Determine the toxic effects of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive CCI-779 IV over 30 minutes on day 1. Courses repeat every 7 days in the absence of disease progression or unacceptable toxicity. Patients are followed for survival. PROJECTED ACCRUAL: Approximately 40-50 patients will be accrued for this study within 12 months.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
DRUG	temsirolimus

Timeline

• Start date: 2001-06-01
• Primary completion: 2005-09-01
• Completion: 2005-09-01
• First posted: 2003-01-27
• Last updated: 2015-06-08

Locations

21 sites across 2 countries: United States, Canada