Clinical trial NCT00074269 (phase 2, status: terminated)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: cyclosporine, fludarabine phosphate, melphalan, methotrexate
SMILES: CC[C@@H]1NC(=O)[C@H]([C@H](O)[C@H](C)C\C=C\C)N(C)C(=O)[C@H](C(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CC(C)C)N(C)C(=O)[C@@H](NC(=O)[C@H](CC(C)C)N(C)C(=O)CN(C)C1=O)C(C)C, NC1=NC(F)=NC2=C1N=CN2[C@@H]1O[C@H](CO)[C@@H](O)[C@@H]1O, N[C@@H](CC1=CC=C(C=C1)N(CCCl)CCCl)C(O)=O, CN(CC1=CN=C2N=C(N)N=C(N)C2=N1)C1=CC=C(C=C1)C(=O)N[C@@H](CCC(O)=O)C(O)=O
Reason stopped: 
    terminated early due to poor enrollment
  
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