DOSE-INTENSE CHEMOTHERAPY AND STEM CELL RESCUE IN THE TREATMENT OF INFLAMMATORY

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。本研究的目的是评价一种治疗方法，包括化疗和手术切除癌症，然后进行额外的化疗，然后进行两个治疗周期的非常高剂量的治疗，并输注患者自己的骨髓来源的细胞。炎性乳腺癌，当常规治疗时，复发的可能性很高。高剂量的联合化疗可能会改善患者的这种结果，目前正在研究一种新的药物和剂量组合。为了减少与高剂量化疗相关的潜在副作用，随后将进行干细胞救援（将患者自身的骨髓来源的细胞重新输注回患者体内的过程）。年龄在18-65岁之间，诊断为IIIB期乳腺癌，并且在诊断后6个月内具有至少一种以下临床特征的患者将入组研究：炎症、红斑、疼痛或超敏反应、水肿（橙色）、皮肤增厚。患者必须在其他方面总体健康状况良好。如果患者之前接受过不超过一个周期的化疗治疗，并且没有手术切除肿瘤，他们将开始使用一种名为阿霉素的药物进行化疗。然后，患者将接受第二种药物紫杉醇，然后手术切除乳腺癌。所有患者将在96小时内通过静脉导管接受泰素。将给予粒细胞集落刺激因子（G-CSF），以增加血液循环中循环骨髓细胞的数量。接下来，患者将接受PBSC（外周血干细胞）采集。该程序包括通过一台机器循环血液，该机器将血液分离成各种成分，并将除了白色血细胞之外的所有血液返回给患者。患者将入院接受第一个周期的高剂量联合化疗，包括多柔比星和环磷酰胺的静脉输注，第二天输注紫杉醇。在此之后，患者将接受先前储存的PBSC的部分再输注。不超过7周后，患者将再次入院接受第二周期的高剂量化疗，其中包括两种药物美法仑和顺铂，然后部分输注之前收集的PBSC。患者将在从高剂量化疗中恢复后接受胸壁和淋巴结区域的放射治疗，并且如果肿瘤是受体阳性，则也将开始服用药物他莫昔芬，为期5年。治疗后，将对患者进行密切监测。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. 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. 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. Patients between the age of 18-65 years, who are diagnosed with stage IIIB breast cancer, and who have at least one of the following clinical features within six months from the time of diagnosis will be enrolled in the study: inflammation, erythema, pain or hypersensitivity, edema (peau d'orange), thickening of skin. Patient must be in otherwise generally good health. 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 than a 7-week period, the patient will be readmitted to receive a second cycle of high-dose chemotherapy, consisting of two drugs 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 the drug, tamoxifen, for a period of 5 years. Following treatment, the patient will be closely monitored.