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


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

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


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.

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

Inclusion 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

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Aminah Jatoi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000068397

NCT ID:

NCT00008320

Start Date:

January 2001

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Scottsdale Oncology ProgramScottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
Siouxland Hematology-OncologySioux City, Iowa  51101-1733
CCOP - Merit Care HospitalFargo, North Dakota  58122
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
Rapid City Regional HospitalRapid City, South Dakota  57709
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
Medcenter One Health SystemBismarck, North Dakota  58501