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， 拓扑异构酶Topotecan治疗黑色素瘤和肾细胞癌 I抑制剂，并确定是否粒细胞-巨噬细胞集落 化疗前给予GM-CSF可预防 骨髓抑制 所有患者每日推注接受托泊替康1.5 mg/m2 静脉输注5天，治疗后GM-CSF 250 ug/m2 日报 患者随机接受不接受额外治疗或（3 M-3 M）治疗。 托泊替康给药前CSF 250 ug/m2，每日两次。 52名患者已进入研究，27名患者 黑色素瘤和25例肾细胞癌。 49名患者 可评价反应，25例黑素瘤患者和24例 肾癌 1例黑色素瘤患者在研究中保持活跃， 尚未对反应进行评价。 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 一名黑色素瘤患者的部分反应， 在大脑发育之前持续六个月的皮下疾病 转移没有看到其他答复。 第一次和第二次化疗后IV级中性粒细胞减少减少 在随机分配至化疗前的患者中观察到拓扑替康周期 GM-CSF 未观察到对血小板计数的保护作用或不良作用， 化疗前接受GM-CSF治疗的患者。

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 (3M- CSF 250 ug/m2 twice daily before Topotecan. Fifty-two patients have been entered on study, twenty-seven patients with melanoma and twenty-five with renal cell cancer. Forty-nine patients are evaluable for response, twenty-five with melanoma and twenty-four with renal cell cancer. One patient with melanoma remains active on study and has not been evaluated for response. One patient with renal cell cancer had complete regression of his lung metastases but no response in his kidney primary. One patient with melanoma had a partial response of his subcutaneous disease that lasted for six months prior to developing brain metastasis. No other responses have been seen. A decrease in grade IV neutropenia following both the first and second cycle of Topotecan has been seen in patients randomized to prechemotherapy GM-CSF. No protective or adverse effect on platelet counts was seen in patients treated with GM-CSF before chemotherapy.