NCT00008320

Ceramide Cream in Treating Women With Cutaneous Breast Cancer

A Phase II Study Of Topical Ceramide Lipids As Treatment For Cutaneous Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: Female
• 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 ceramide cream in treating women who have cutaneous breast cancer.

Detailed description

OBJECTIVES: I. Determine the objective response rate in women with cutaneous breast cancer treated with topical ceramide cream. II. Determine the time to progression in patients treated with this regimen. III. Determine the toxicity of this regimen in these patients. IV. Assess the quality of life of these patients treated with this regimen. OUTLINE: Topical ceramide cream is applied to all cutaneous lesions twice daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and then at 1 and 3 months. Patients are followed every 3 months for 1 year and then every 6 months for 4 years.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	ceramide

Timeline

• Start date: 2001-01-01
• Primary completion: 2002-04-01
• Completion: 2009-10-01
• First posted: 2004-03-25
• Last updated: 2016-12-06

Locations

13 sites across 1 country: United States