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.

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。子弹和调查员（PI）可能已经从其他NIH来源获得了主要资金，因此可以在其他清晰的条目中代表。列出的机构适用于该中心，这不一定是调查员的机构。这项研究的目的是评估包括化学疗法和外科手术切除癌症的治疗方法，然后再进行其他化学疗法，然后对非常高剂量治疗的两个治疗循环，并重新连接患者自身的骨髓衍生的细胞。炎症性乳腺癌常规治疗时会带来很大的复发性。高剂量的组合化疗可能会改善患者的结果，并研究了新的药物和剂量。为了减少与高剂量化学疗法相关的潜在副作用，将随后将干细胞救援（患者自身的骨髓衍生细胞恢复到它们的过程中）。该研究将在诊断后的六个月内被诊断出患有IIIB期乳腺癌的18-65岁患者，至少具有以下临床特征之一：炎症，炎症，红斑，疼痛或高度敏感性，水肿，peau d'Orange），皮肤增厚。患者必须身体健康。如果患者接受了不超过一个先前的周期化疗治疗，并且没有手术切除其肿瘤，他们将开始使用一种称为阿霉素的药物进行化学疗法。然后，患者将接受第二种药物紫杉醇，然后将手术切除乳腺癌。所有患者将在96小时内通过静脉内导管接受紫杉醇。将施用粒细胞落刺激因子（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）收集。该过程涉及将血液循环的机器循环，该机器将血液分为成分，并将白细胞以外的所有东西都归还给患者。该患者将被送往医院接受他们的第一个高剂量组合化疗周期，包括阿霉素和环磷酰胺的静脉注射，第二天是输注紫杉醇。此后，患者将获得以前存储的PBSC的部分恢复。在不超过7周的时间后，将重新入院以接受第二个高剂量化疗周期，包括两种药物Melphalan和Cisplatin，然后是对先前收集的PBSC的部分恢复。从高剂量化学疗法中恢复后，患者将接受放射治疗，淋巴结区域，如果肿瘤为激素受体阳性，也将开始服用该药物的他莫昔芬，为期5年。治疗后，将密切监测患者。