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

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:
3853315
负责人:
J E JANIK
金额:
$0.0万
依托单位国家:
美国
项目类别:
财政年份:
--
资助国家:
美国
项目状态:
未结题
起止时间:
至

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中文摘要
翻译
这项试验旨在测试重组粒细胞的能力 巨噬细胞集落刺激因子(RGM-CSF)对慢性粒细胞白血病患者的保护作用 难治性卵巢癌的骨髓抑制作用 大剂量卡铂。先前对大剂量卡铂的研究 晚期卵巢癌患者的有效率为27% 癌症。治疗与严重的和长期的 骨髓抑制。在这项试验中,卡铂每隔35天给药一次 天数,剂量为800 mg/m~2。给予不同剂量的重组粒细胞集落刺激因子 从卡铂给药三天后开始。本研究 是与国家癌症医学分会联合进行的 研究所。八名患者已在生物反应中心接受治疗 修改剂计划(BRMP)。所有患者都经历了显著的 大剂量卡铂引起的骨髓抑制和除一名患者外的所有患者 由于这种骨髓抑制,化疗所需的剂量减少。 所有患者都经历了严重的血小板减少症和 需要输注血小板。所有需要的病人 在治疗过程中住院治疗。八名患者中的两名 使用最高剂量的GM-CSF治疗不需要 因粒细胞减少和发烧住院。GM-CSF是否缩短 粒细胞减少的持续时间不能从这项研究中确定。 血小板减少症持续严重且持续时间长,似乎没有 都受到了GM-CSF的影响。在7名接受评估的患者中 在BRMP中,有三个部分反应和一个完整反应。
英文摘要
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 carboplatin. A previous study with high-dose carboplatin demonstrated a response rate of 27% in patients with advanced ovarian carcinoma. Therapy was associated with severe and prolonged myelosuppression. In this trial, carboplatin 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 carboplatin. This study was conducted jointly with the Medicine Branch of the National Cancer Institute. Eight patients have been treated at the Biological Response Modifiers Program (BRMP). All patients experienced significant myelosuppression following high-dose carboplatin 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 been affected by GM-CSF. In seven evaluable patients treated at the BRMP, there were three partial and one complete responses.
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PHASE II EFFICACY STUDY OF ROFERON A IN HAIRY CELL LEUKEMIA
RGM-CSF AND HIGH DOSE CARBOPLATIN THERAPY IN REFRACTORY OVARIAN CANCER
  • 批准号:
    3874539
  • 项目类别:
  • 资助金额:
    $0.0万
  • 财政年份:
    --
  • 负责人:
    J E JANIK
  • 依托单位:
PHASE IB TRIAL OF LEVAMISOLE ALONE AND IN COMBINATION WITH R-INTERFERON GAMMA
POLY ICLC AND ALPHA INTERFERON IN REFRACTORY MALIGNANCY
  • 批准号:
    3838223
  • 项目类别:
  • 资助金额:
    $0.0万
  • 财政年份:
    --
  • 负责人:
    J E JANIK
  • 依托单位: