RGM-CSF AND HIGH DOSE CARBOPLATIN THERAPY IN REFRACTORY OVARIAN CANCER

RGM-CSF 和高剂量卡铂治疗难治性卵巢癌

• 批准号: 3874539
• 负责人: J E JANIK
• 金额: --
• 依托单位: DIVISION OF CANCER TREATMENT
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/3874539
• 关键词: biological response modifiers; cis platinum compound; clinical trials; colony stimulating factor; combination cancer therapy; dosage; drug adverse effect; granulocytopenia; human subject; human therapy evaluation; immunomodulators; immunosuppression; neoplasm /cancer chemotherapy; neoplasm /cancer immunotherapy; ovary neoplasms; thrombocytopenia

This trial was designed to test the ability of recombinant granulocyte macrophage-colony stimulating factor (rGM-CSF) to protect patients with refractory ovarian carcinoma from the bone marrow suppressive effects of high-dose carboplatinum. A previous study with high-dose carboplatinum demonstrated a response rate of 27% in patients with advanced ovarian carcinoma. Therapy was associated with severe and prolonged myelosuppression. In this trial, carboplatinum was administered every 35 days at a dose of 800 mg/m sq. rGM-CSF was given at various doses beginning three days after administration of carboplatinum. This study is being conducted jointly with the Medicine Branch of the National Cancer Institute. Eight patients experienced significant myelosuppression following high-dose carboplatinum and all but one patient required dose reductions in chemotherapy due to this myelosuppression. All of the patients experienced significant thrombocytopenia and required platelet transfusions. All of the patients required hospitalization during the course of therapy. Two of the eight patients treated at the highest dose level of GM-CSF did not require hospitalization for granulocytopenia and fever. Whether GM-CSF shortens the duration of granulocytopenia cannot be determined from this study. Thrombocytopenia has remained severe and prolonged and appears not to have ben affected by GM-CSF. Six of the eight patients treated at the Biological Response Modifiers Program are evaluable for response. Three responses, two partial and one complete response were seen.

本试验旨在检测重组粒细胞 巨噬细胞集落刺激因子（rGM-CSF）保护患者 难治性卵巢癌的骨髓抑制作用 大剂量卡铂 之前的一项研究显示， 在晚期卵巢癌患者中， carcinoma. 治疗与严重和长期的 骨髓抑制 在这项试验中，卡铂每35 天的剂量为800毫克/平方米。 以不同剂量给予rGM-CSF 从卡铂给药后三天开始。 本研究 正在与国家癌症研究所医学分支联合进行 院 8例患者发生了显著的骨髓抑制 在高剂量卡铂后，除一名患者外，所有患者均需要剂量 由于这种骨髓抑制，化疗减少。 所有 患者出现严重血小板减少症，需要血小板 输血 所有患者在治疗期间都需要住院治疗。 治疗过程。 在接受最高剂量治疗的8名患者中， GM-CSF水平不需要因粒细胞减少症住院， 发烧 GM-CSF是否能缩短粒细胞减少症的持续时间， 从这项研究中确定。 血小板减少症仍为重度， 延长，似乎没有受到GM-CSF的影响。 八人中的六人 在生物反应调节剂项目中接受治疗的患者是可评价的 来回应。 三个答复，两个部分答复和一个完全答复， 见过