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.

Condition	Treatment or Intervention	Phase
stage IV breast cancer recurrent breast cancer	Drug: ceramide	Phase II

Further Study Details: 

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.

PROTOCOL 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.

PROJECTED ACCRUAL: A total of 22 patients will be accrued for this study within 27 months.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically or cytologically confirmed cutaneous breast cancer for which no curative or significantly palliative therapy exists including chest wall radiotherapy
• Measurable disease
• Disease progression after at least 1 hormonal therapy for estrogen receptor positive disease and after radiotherapy if chest wall disease has been previously irradiated
• No infection at site of cutaneous metastatic disease
• Hormone receptor status: Estrogen receptor status known

--Prior/Concurrent Therapy--

• Biologic therapy: No concurrent biologic therapy during first 2 months of study
• Chemotherapy: No other concurrent local antineoplastic therapy for cutaneous disease; No concurrent systemic chemotherapy during first 2 months of study
• Endocrine therapy: See Disease Characteristics
• Radiotherapy: See Disease Characteristics; At least 4 weeks since prior radiotherapy; No concurrent radiotherapy during first 2 months of study except for CNS disease
• Surgery: Not specified

--Patient Characteristics--

• Age: 18 and over
• Sex: Female
• Menopausal status: Not specified
• Performance status: ECOG 0-3
• Life expectancy: At least 12 weeks
• Hematopoietic: Not specified
• Hepatic: Not specified
• Renal: Not specified
• Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception

Arizona
      CCOP - Scottsdale Oncology Program, Scottsdale,  Arizona,  85259-5404,  United States
Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States
Iowa
      CCOP - Cedar Rapids Oncology Project, Cedar Rapids,  Iowa,  52403-1206,  United States
      CCOP - Iowa Oncology Research Association, Des Moines,  Iowa,  50309-1016,  United States
      Siouxland Hematology-Oncology, Sioux City,  Iowa,  51101-1733,  United States
Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States
Minnesota
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States
Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68131,  United States
North Dakota
      CCOP - Merit Care Hospital, Fargo,  North Dakota,  58122,  United States
      Medcenter One Health System, Bismarck,  North Dakota,  58501,  United States
Ohio
      CCOP - Toledo Community Hospital Oncology Program, Toledo,  Ohio,  43623-3456,  United States
South Dakota
      CCOP - Sioux Community Cancer Consortium, Sioux Falls,  South Dakota,  57105-1080,  United States
      Rapid City Regional Hospital, Rapid City,  South Dakota,  57709,  United States

Study chairs or principal investigators

Aminah Jatoi,  Study Chair,  North Central Cancer Treatment Group   

Study ID Numbers:  CDR0000068397; NCCTG-N0031
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  January 6, 2001
ClinicalTrials.gov Identifier:  NCT00008320
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08