PHASE II EVALUATION OF TOPOTECAN IN MELANOMA AND RENAL CELL CARCINOMA

本议定书的目的是确定第二阶段的反应率 黑色素瘤和肾细胞癌的治疗与拓扑替康， 拓扑异构酶I抑制剂，并确定是否粒细胞-巨噬细胞 化疗前给予集落刺激因子（GM-CSF）可预防 骨髓抑制 所有患者每天接受托泊替康1.5 mg/m2， 静脉推注5天，治疗后GM-CSF 250 每天ug/m2。 患者被随机分组，不接受其他治疗 或GM-CSF 250 ug/m2，每日两次。 21例患者入组研究，9例患者 黑色素瘤和12例肾细胞癌。 16名患者 缓解可评价，8例黑素瘤患者和8例肾细胞癌患者 癌 没有收到任何答复。 1例肾细胞癌患者 他的肺转移完全消退，但在他的 原发性肾脏病 托泊替康第一个周期后IV级中性粒细胞减少减少 已经被看到了。 7例接受治疗前GM-CSF治疗的患者中， 除治疗后GM-CSF发生IV级粒细胞减少症外 而11例仅在术后接受GM-CSF的患者中有8例 化疗后出现IV级粒细胞减少症。

The purpose of this protocol is to determine the phase II response rate of melanoma and renal cell cancer to therapy with Topotecan, a topoisomerase I inhibitor and to determine whether granulocyte-macrophage colony stimulating factor (GM-CSF) given before chemotherapy prevents myelosuppression. All patients receive Topotecan 1.5 mg/m2 daily by bolus intravenous infusion for five days and post-therapy GM-CSF 250 ug/m2 daily. Patients are randomized to receive no additional therapy or GM-CSF 250 ug/m2 twice daily before Topotecan. Twenty-one patients have been entered on study, nine patients with melanoma and twelve with renal cell cancer. Sixteen patients are evaluable for response, eight with melanoma and eight with renal cell cancer. No responses have been seen. One patient with renal cell cancer had complete regression of his lung metastases but no response in his kidney primary. A decrease in grade IV neutropenia following the first cycle of Topotecan has been seen. One of seven patients treated with pretherapy GM-CSF in addition to post therapy GM-CSF experienced grade IV granulocytopenia whereas eight of eleven patients who received GM-CSF only after chemotherapy had grade IV granulocytopenia.