RGM-CSF AND HIGH DOSE CARBOPLATIN THERAPY IN REFRACTORY OVARIAN CANCER
RGM-CSF AND HIGH DOSE CARBOPLATIN THERAPY IN REFRACTORY OVARIAN CANCER
批准号:
3874539
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
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
中文摘要
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
大剂量的卡铂。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
从服用卡铂三天后开始。这项研究是
与国家癌症医学分会联合进行
研究所。8名患者经历了严重的骨髓抑制。
服用大剂量卡铂后,除一名患者外,所有患者都需要剂量
由于这种骨髓抑制,化疗减少了。所有的
患者出现严重的血小板减少症并需要血小板
输血。所有的病人都需要住院治疗。
疗程。在接受最大剂量治疗的八名患者中,有两名
GM-CSF水平不需要住院治疗粒细胞减少症和
发烧。GM-CSF能否缩短粒细胞减少症的病程尚不能确定
从这项研究中确定的。血小板减少症仍然很严重,
持续了很长时间,似乎没有受到GM-CSF的影响。八个中的六个
接受生物反应调节剂计划治疗的患者是可评估的
以示回应。三份回复,两份部分回复和一份完全回复
看到了。
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 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.
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会议论文
PHASE II EFFICACY STUDY OF ROFERON A IN HAIRY CELL LEUKEMIA
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批准号:2464506
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项目类别:
-
资助金额:$0.0万
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财政年份:--
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负责人:J E JANIK
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依托单位:
PHASE IB TRIAL OF LEVAMISOLE ALONE AND IN COMBINATION WITH R-INTERFERON GAMMA
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批准号:2464513
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项目类别:
-
资助金额:$0.0万
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财政年份:--
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负责人:J E JANIK
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依托单位:
PHASE I TRIAL OF TNF AND GM-CSF
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批准号:3752523
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项目类别:
-
资助金额:$0.0万
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财政年份:--
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负责人:J E JANIK
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依托单位:
PHASE II EVALUATION OF TOPOTECAN IN MELANOMA AND RENAL CELL CARCINOMA
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批准号:3752507
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项目类别:
-
资助金额:$0.0万
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财政年份:--
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负责人:J E JANIK
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依托单位:
PHASE II EFFICACY STUDY OF ROFERON A (R022-8181/002) IN HAIRY CELL LEUKEMIA
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批准号:3752481
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项目类别:
-
资助金额:$0.0万
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财政年份:--
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负责人:J E JANIK
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依托单位:
POLY ICLC AND ALPHA INTERFERON IN REFRACTORY MALIGNANCY
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批准号:3838223
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项目类别:
-
资助金额:$0.0万
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财政年份:--
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负责人:J E JANIK
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依托单位:
PHASE 1 EVALUATION OF INTRATUMORAL INTERLEUKIN-1 ALPHA
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批准号:3853339
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项目类别:
-
资助金额:$0.0万
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财政年份:--
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负责人:J E JANIK
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依托单位:
PHASE I EVALUATION OF A MODIFIED HEPATIC ARTERY INFUSION CATHETER
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批准号:3752508
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项目类别:
-
资助金额:$0.0万
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财政年份:--
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负责人:J E JANIK
-
依托单位:
PHASE 1 EVALUATION OF INTRATUMORAL INTERLEUKIN-1 ALPHA
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批准号:3838227
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项目类别:
-
资助金额:$0.0万
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财政年份:--
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负责人:J E JANIK
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依托单位:
PHASE II EVALUATION OF TOPOTECAN IN MELANOMA AND RENAL CELL CARCINOMA
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批准号:3838238
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项目类别:
-
资助金额:$0.0万
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财政年份:--
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负责人:J E JANIK
-
依托单位:
PHASE II EFFICACY STUDY OF ROFERON A IN HAIRY CELL LEUKEMIA
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批准号:6163345
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项目类别:
-
资助金额:$0.0万
-
财政年份:--
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负责人:J E JANIK
-
依托单位:
PHASE I EVALUATION OF A MODIFIED HEPATIC ARTERY INFUSION CATHETER
-
批准号:3838239
-
项目类别:
-
资助金额:$0.0万
-
财政年份:--
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负责人:J E JANIK
-
依托单位:
POLY ICLC AND ALPHA INTERFERON IN REFRACTORY MALIGNANCY
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批准号:3853335
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项目类别:
-
资助金额:$0.0万
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财政年份:--
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负责人:J E JANIK
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依托单位:
ALTERNATING 2'-DCF AND RECOMBINANT LEUKOCYTE INTERFERON ALPHA IN HCL
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批准号:2464504
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项目类别:
-
资助金额:$0.0万
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财政年份:--
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负责人:J E JANIK
-
依托单位:
PHASE II EFFICACY STUDY OF ROFERON A IN HAIRY CELL LEUKEMIA
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批准号:6163429
-
项目类别:
-
资助金额:$0.0万
-
财政年份:--
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负责人:J E JANIK
-
依托单位:
ALTERNATING 2'-DCF AND RECOMBINANT LEUKOCYTE A IFN IN HAIRY CELL LEUKEMIA
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批准号:3752475
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项目类别:
-
资助金额:$0.0万
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财政年份:--
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负责人:J E JANIK
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依托单位:
PHASE IB TRIAL OF LEVAMISOLE ALONE AND IN COMBINATION WITH RIFN-GAMMA
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批准号:3752495
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项目类别:
-
资助金额:$0.0万
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财政年份:--
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负责人:J E JANIK
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依托单位:
POLY ICLC AND ALPHA INTERFERON IN REFRACTORY MALIGNANCY
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批准号:3752497
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项目类别:
-
资助金额:$0.0万
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财政年份:--
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负责人:J E JANIK
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依托单位:
POLY ICLC AND ALPHA INTERFERON IN REFRACTORY MALIGNANCY
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批准号:3874559
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项目类别:
-
资助金额:$0.0万
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财政年份:--
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负责人:J E JANIK
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依托单位:
RGM-CSF AND HIGH DOSE CARBOPLATIN THERAPY IN REFRACTORY OVARIAN CANCER
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批准号:3853315
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项目类别:
-
资助金额:$0.0万
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财政年份:--
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负责人:J E JANIK
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依托单位: