3.9 Adequate pulmonary function: DLCO >50% compensated for Hemoglobin; FEV 
>55%, pC >2 >60mm Hg. 
3.10 Histologically negative bilateral bone marrow biopsies both prior to and at bone 
marrow harvest. 
3.11 No evidence of metastatic disease to the bone by bone scan after induction 
chemotherapy. No prior pelvic radiation therapy and <20% of bone marrow 
previously radiated. 
3.12 WBC >3500/mm 3 and platelets >100 ,000/mm 3 . 
3.13 ECOG performance status 0, 1 , 2 and a life expectancy >60 days. 
3.14 Negative beta-HCG serum pregnancy test in patients of child-bearing age. 
3.15 Ability to give informed consent. 
3.16 Good psychiatric and medical risk. All patients will undergo a psychosocial evaluation 
by the breast cancer psychiatric social worker. 
3.17 Marrow harvest of >1 x 10 8 nucleated cells/Kg body weight (preprocessing) will be 
required for the patient to undergo transplantation with the MDR-1 -transduced cells. 
4.0 Pretreatment Evaluation 
4. 1 Complete history and physical examination with measurement of all palpable 
peripheral lymph nodes, liver, and other measurable lesions. 
4.2 Hematological and Serological Studies: CBC with differential count, platelets, 
reticulocyte count, Westergren sedimentation rate, PT, PTT, Coomb's test, HIV 
serology, Hepatitis B surface Ag/Ab, CMV and HSV serology and HLA blood typing. 
4.3 Chemistry Studies: Acute Care, Hepatic and Mineral panels, Uric Acid, LDH, CPK, 
Amylase, Thyroid function tests (Free T4, TSH), Total Protein, 24 hour urine for 
creatinine clearance and total protein, urinalysis, beta-HCG in patients of child-bearing 
age. 
4.4 Radiological Studies: 
4.4. 1 Chest and abdominal CT scan. 
4.4.2 Head CT scan. 
4.4.3 Bone Survey and bone scan. 
4.5 Pulmonary Function Tests with DLCO and arterial blood gas. 
4.6 Nuclear Medicine cardiac ejection fraction (MUGA scan) and exercise treadmill test. 
4.7 Bilateral iliac crest bone marrow biopsies and aspirates for routine staining. 
4. 8 CSF examination with cytology if disease clinically suspected. 
4.9 Audiogram prior to and one month following discharge from hospital for bone marrow 
transplant. 
4. 10 Serum for baseline study for the presence of wild-type virus and antibodies to 
retroviral proteins. 
4.11 Obtaining paraffin blocks of patient's breast cancer for immunohistochemistry for Pgp 
expression. Patients with accessible tumor will undergo fine needle aspirate and/or 
biopsy of their breast cancer for Pgp analysis of fresh tissue as well. Lesions to 
undergo FNA include breast, skin, nodal, lung or liver disease. Lesions to undergo 
biopsy include breast, skin, and nodal disease. 
4.12 1 purple top tube of blood and a marrow aspirate will be obtained for DNA and RNA 
analysis as controls. 
5.0 Treatment Plan 
5.1 Patient Registration: All patients must be registered on study by the clinical associate 
by contacting Orkand at 402-1732 (8:30 A.M. - 5:00 P.M., Monday - Friday) with the 
appropriate patient information. Patients must also be officially taken off study by 
contacting Orkand Personnel. 
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