NCT Number: NCT00008320
Ceramide Cream in Treating Women With Cutaneous Breast Cancer
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.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
Female
Study type
Interventional
Phase
Phase 2
Primary location
CCOP - Scottsdale Oncology Program, Scottsdale, Arizona, United States
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
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
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
Treatment and study plan
Primary outcomes
-
response rate
Time frame: up to 5 years
Secondary outcomes
-
time to progression
Time frame: Up to 5 years
-
quality of life
Time frame: Up to 5 years
Sponsors and collaborators
Lead sponsor
Alliance for Clinical Trials in Oncology
Other
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study title
A Phase II Study Of Topical Ceramide Lipids As Treatment For Cutaneous Breast Cancer
Important dates
- Study start
- 2001
- Primary completion
- 2002
- Study completion
- 2009
- First posted
- Mar 25, 2004
- Registry last updated
- Dec 6, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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