Spots Global Cancer Trial Database for Ceramide Cream in Treating Women With Cutaneous Breast Cancer

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Trial Identification

Brief Title: Ceramide Cream in Treating Women With Cutaneous Breast Cancer

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

Study ID: NCT00008320

Conditions

Breast Cancer

Interventions

ceramide

Study Description

Brief 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.