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

炎症治疗中的大剂量化疗和干细胞拯救

• 批准号: 7368147
• 负责人: GEORGE SOMLO
• 金额: $ 4.57万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7368147
• 关键词: DOSE; INTENSE; CHEMOTHERAPY; STEM; CELL

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.

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。这项研究的目的是评估一种包括化疗和手术切除肿瘤，然后附加化疗，然后两个治疗周期的非常高剂量的治疗与回输患者自己的骨髓来源的细胞。炎症性乳腺癌，如果按常规治疗，复发的可能性很高。大剂量的联合化疗可能会改善患者的结果，目前正在研究一种新的药物和剂量组合。为了减少与大剂量化疗相关的潜在副作用，干细胞拯救(患者自己的骨髓来源细胞被重新注入其中的过程)将随之而来。年龄在18-65岁之间，被诊断为IIIB期乳腺癌，并在确诊后6个月内至少有以下临床特征之一的患者将参加研究：炎症、红斑、疼痛或过敏症、水肿症(橙色)、皮肤增厚。病人必须在其他方面身体状况良好。如果患者之前接受过不超过一次的化疗，并且没有接受过手术切除肿瘤，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，然后手术切除他们的乳腺癌。所有患者都将在96小时内通过静脉导管接受紫杉醇治疗。将使用粒细胞集落刺激因子(G-CSF)来增加血液循环中的循环骨髓细胞数量。接下来，患者将接受PBSC(外周血干细胞)采集。这一过程包括通过一台机器循环血液，机器将血液分离成组分，并将除白细胞以外的所有东西都返回给患者。患者将入院接受第一个周期的大剂量联合化疗，包括静脉输注阿霉素和环磷酰胺，第二天输注紫杉醇。之后，患者将接受之前储存的PBSC的部分回输。在不超过7周的时间后，患者将重新入院接受第二个周期的大剂量化疗，包括两种药物马法兰和顺铂，然后部分回输之前收集的PBSC。在大剂量化疗恢复后，患者将接受胸壁和淋巴结区的放射治疗，如果肿瘤激素受体呈阳性，还将开始服用药物他莫昔芬，为期5年。在接受治疗后，患者将受到密切监测。