Allogeneic Stem Cell Transplant After ATG, High-Dose Melphalan, and Fludarabine for Patients With Breast Cancer
Breast Cancer

About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring recurrent breast cancer, stage IV breast cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the breast Metastatic disease Meets 1 of the following criteria: Chemotherapy-unresponsive disease defined as 1 of the following: Less than a partial response to 2 consecutive chemotherapy regimens that included an anthracycline and a taxane in combination or succession Progression of disease during or within 3 months of completion of a taxane, anthracycline, or platinol-based regimen Histologically confirmed tumor involvement on bone marrow biopsy Measurable or evaluable disease* defined as the following: Bidimensionally reproducible measurable mass by physical examination, ultrasonography, radiography, CT scan, or MRI Evaluable lesions apparent on clinical exam, x-ray, CT scan, or MRI which do not fit the criteria for measurability (e.g., ill-defined post-surgical masses or masses assessable in 1 dimension only) Elevation of biological markers (e.g., CA 27.29) is considered evaluable disease NOTE: *Bone lesions or pleural or peritoneal effusion alone are not considered measurable or evaluable disease Appropriate candidate for allogeneic stem cell transplantation No active CNS metastases Available HLA-identical sibling donor 6/6 antigen match Donor CD34 cells at least 2 times 10^6/kg recipient weight Hormone receptor status: Estrogen receptor negative or positive Estrogen receptor positive tumors must demonstrate progression on at least 1 hormonal manipulation PATIENT CHARACTERISTICS: Age 18 to 60 Sex Female Menopausal status Not specified Performance status Karnofsky 70-100% OR ECOG 0-1 Life expectancy Not specified Hematopoietic WBC at least 1,500/mm^3 Platelet count at least 30,000/mm^3 Hepatic Bilirubin less than 3 times normal* AST and ALT less than 3 times normal* NOTE: *Unless abnormality due to malignancy Renal Creatinine no greater than 1.6 mg/dL Cardiovascular LVEF greater than 40% by echocardiography or MUGA No myocardial infarction within the past 6 months Pulmonary DLCO greater than 40% of predicted Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No serious localized or systemic infection No hypersensitivity to E. coli-derived products No history of non-breast malignant disease within the past 5 years except completely excised nonmelanoma skin cancer or carcinoma in situ of the cervix No chronic inflammatory disorder requiring concurrent glucocorticosteroids or other immunosuppressive medication No psychological condition or social situation that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics Endocrine therapy No concurrent glucocorticoids Radiotherapy No prior radiotherapy to an indicator lesion unless the lesion shows evidence of progression after discontinuation of the therapy Surgery Not specified Other No concurrent immunosuppressive medication
Sites / Locations
- Rebecca and John Moores UCSD Cancer Center
Arms of the Study
Arm 1
Experimental
treatment