DOSE INTENSE CHEMOTHERAPY & STEM CELL RESCUE IN INFLAMMATORY BREAST CANCER

剂量强化化疗

• 批准号: 6263716
• 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: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6263716
• 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.

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。 2）概述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）。 3）谁可能有资格？：大约18-65岁；被诊断为IIIB期乳腺癌；从诊断后的六个月内，必须至少具有以下临床特征之一：炎症，红斑，疼痛或过敏性，水肿（Peau d'Orange），皮肤增厚。 患者必须身体健康。 4）治疗的描述：如果患者接受了不超过一个以前的周期化疗治疗，并且没有手术切除其肿瘤，则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。该过程涉及通过将血液分离成成分的机器循环血液，除了白细胞外，所有的一切都将其返回患者。患者将被送往医院接受高剂量组合化疗的第一个周期，包括静脉注射阿霉素和环磷酰胺的静脉输注，第二天，以及第二天的分类酚。 此后，患者将获得以前存储的PBSC的部分恢复。 经过7周的时间之后，该患者将被重新入院，以接受第二个高剂量化疗周期，包括两种药物Melphalan和Cisplatin。 从治疗开始的一个星期，患者将获得另一剂Melphalan和Cisplatin的剂量，随后，部分恢复了先前收集的PBSC。 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，也将开始服用一种他莫昔芬的药物，为期5年。 治疗后，将密切监测患者。