DOSE INTENSE CHEMOTHERAPY & STEM CELL RESCUE IN INFLAMMATORY BREAST CANCER

剂量强化化疗

• 批准号: 6303635
• 负责人: GEORGE SOMLO
• 金额: $ 3.56万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-12-01 至 2000-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6303635
• 关键词: bone marrow transplantation; breast neoplasms; cis platinum compound; clinical research; colony stimulating factor; combination cancer therapy; combination chemotherapy; cyclophosphamide; doxorubicin; homologous transplantation; human subject; human therapy evaluation; melphalan; neoplasm /cancer chemotherapy; neoplasm /cancer immunotherapy; neoplasm /cancer surgery; paclitaxel

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.

本研究的目的是评估一种治疗方法，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高剂量治疗，并回输患者自身的骨髓衍生细胞。 2) 概述 炎性乳腺癌在采用常规治疗时，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，并且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，将进行干细胞拯救（将患者自身的骨髓来源的细胞回输回体内的过程）。 3) 谁有资格？： 年龄约 18-65 岁；诊断患有 IIIB 期乳腺癌；诊断后六个月内必须至少具有以下临床特征之一：炎症、红斑、疼痛或过敏、水肿（橙皮）、皮肤增厚。 患者必须身体健康。 4) 治疗描述：如果患者之前接受过不超过一个周期的化疗，并且尚未手术切除肿瘤，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，然后通过手术切除乳腺癌。所有患者将在 96 小时内通过静脉导管接受紫杉醇。将施用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。 该过程包括通过一台机器循环血液，该机器将血液分离成成分，并将除白细胞外的所有物质返回患者体内。患者将入院接受第一周期的高剂量联合化疗，包括静脉输注阿霉素和环磷酰胺，第二天输注紫杉醇。此后，患者将接受之前储存的 PBSC 的部分回输。不超过 7 周后，患者将重新入院接受第二个周期的高剂量化疗，包括马法兰和顺铂两种药物。 治疗开始一周后，患者将接受另一剂美法仑和顺铂，然后部分回输之前收集的 PBSC。从大剂量化疗恢复后，患者将接受胸壁和淋巴结区域的放射治疗，如果肿瘤呈激素受体阳性，还将开始服用药物他莫昔芬，为期 5 年。 治疗后，将密切监测患者。