The purpose of this study is to evaluate a treatment consisting of chemotherapy and surgical removal of cancer followed by additional chemotherapy and then two treatment cycles of very high-dose therapy with reinfusion of patient's own bone marrow derived cells. 2) Overview Inflammatory breast cancer, when treated conventionally, carries a high likelihood of relapse. High doses of combination chemotherapy may improve this outcome for patients and a new combination of drugs and doses is being investigated. To reduce the potential side effects associated with high dose chemotherapy, stem cell rescue (a process in which the patient's own bone marrow derived cells are reinfused back to them) will follow. 3) Who Is Potentially Eligible?: Age approximately 18-65 years; Diagnosed with stage IIIB breast cancer; Must have at least one of the following clinical features within six months from time of diagnosis: inflammation, erythema,pain or hypersensitivity, edema (peau d'orange), thickening of skin. Patient must be in otherwise generally good health. 4) Description of Treatment: If the patient has received no more than one prior cycle chemotherapy treatment and has not had surgical removal of their tumor, they will begin chemotherapy with a drug called doxorubicin. Then, the patient will receive a second drug, Taxol, followed by surgical removal of their breast cancer. All patients will receive Taxol through an intravenous catheter over a period of 96 hours. Granulocyte colony stimulating factor (G-CSF) will be administered to increase the number of circulating bone marrow cells in their blood circulation. Next, the patient will undergo PBSC (peripheral blood stem cell) collection. The procedure involves circulating blood through a machine that separates the blood into components and returns everything but the white blood cells back to the patient.The patient will be admitted to the hospital to receive their first cycle of high-dose combination chemotherapy, consisting of intravenous infusions of doxorubicin and cyclophosphamide, and the next day, an infusion of Taxol. Following this, the patient will receive partial reinfusions of their previously stored PBSC. After no more then a 7-week period, the patient will be readmitted to receive a second cycle of high-dose chemotherapy, consisting of the two drugs melphalan and cisplatin. One week from the beginning of their therapy the patient will receive another dose of melphalan and cisplatin, and following that, partial reinfusions of previously collected PBSC. The patient will receive radiation therapy to the chest wall and lymph node areas following recovery from high-dose chemotherapy, and if the tumor was hormone-receptor positive, will also start taking a drug, tamoxifen, for a period of 5 years. Following treatment, the patient will be closely monitored.

Project Start
1999-12-01
Project End
2000-11-30
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
40
Fiscal Year
2000
Total Cost
$35,553
Indirect Cost
Name
University of Southern California
Department
Type
DUNS #
041544081
City
Los Angeles
State
CA
Country
United States
Zip Code
90089
Kelsey, Megan M; Braffett, Barbara H; Geffner, Mitchell E et al. (2018) Menstrual Dysfunction in Girls From the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Study. J Clin Endocrinol Metab 103:2309-2318
Davis, J N; Asigbee, F M; Markowitz, A K et al. (2018) Consumption of artificial sweetened beverages associated with adiposity and increasing HbA1c in Hispanic youth. Clin Obes 8:236-243
Kleinberger, Jeffrey W; Copeland, Kenneth C; Gandica, Rachelle G et al. (2018) Monogenic diabetes in overweight and obese youth diagnosed with type 2 diabetes: the TODAY clinical trial. Genet Med 20:583-590
Berkowitz, Robert I; Marcus, Marsha D; Anderson, Barbara J et al. (2018) Adherence to a lifestyle program for youth with type 2 diabetes and its association with treatment outcome in the TODAY clinical trial. Pediatr Diabetes 19:191-198
Kriska, Andrea; El Ghormli, Laure; Copeland, Kenneth C et al. (2018) Impact of lifestyle behavior change on glycemic control in youth with type 2 diabetes. Pediatr Diabetes 19:36-44
Venditti, E M; Tan, K; Chang, N et al. (2018) Barriers and strategies for oral medication adherence among children and adolescents with Type 2 diabetes. Diabetes Res Clin Pract 139:24-31
Detterich, Jon A (2018) Simple chronic transfusion therapy, a crucial therapeutic option for sickle cell disease, improves but does not normalize blood rheology: What should be our goals for transfusion therapy? Clin Hemorheol Microcirc 68:173-186
Gidding, Samuel S; Bacha, Fida; Bjornstad, Petter et al. (2018) Cardiac Biomarkers in Youth with Type 2 Diabetes Mellitus: Results from the TODAY Study. J Pediatr 192:86-92.e5
Cooper, Aaron R; Lill, Georgia R; Shaw, Kit et al. (2017) Cytoreductive conditioning intensity predicts clonal diversity in ADA-SCID retroviral gene therapy patients. Blood 129:2624-2635
Arslanian, Silva; El Ghormli, Laure; Bacha, Fida et al. (2017) Adiponectin, Insulin Sensitivity, ?-Cell Function, and Racial/Ethnic Disparity in Treatment Failure Rates in TODAY. Diabetes Care 40:85-93

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