PHASE II EVALUATION OF TOPOTECAN IN MELANOMA AND RENAL CELL CARCINOMA

拓扑替康在黑色素瘤和肾细胞癌中的 II 期评估

• 批准号: 3752507
• 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/3752507
• 关键词: DNA topoisomerases; brain neoplasms; clinical trials; colony stimulating factor; enzyme inhibitors; granulocytopenia; human subject; human therapy evaluation; human tissue; intravenous administration; kidney neoplasms; lung neoplasms; melanoma; metastasis; neoplasm /cancer chemotherapy; neoplasm /cancer remission /regression; platelets; renal cell carcinoma

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.

该方案的目的是确定以下项目的第二阶段应答率 拓扑异构酶拓扑替康治疗黑色素瘤和肾癌 I抑制剂和测定粒细胞-巨噬细胞集落形成 化疗前给予刺激因子(GM-CSF)可预防 骨髓抑制。所有患者每日推注拓扑替康1.5 mg/m2。 静脉滴注5天，治疗后GM-CSF 250ug/m2 每天。患者被随机分为不接受额外治疗或(3M- 脑脊液250ug/m2，每日两次，在拓扑替康之前。 52名患者进入研究，27名患者患有 黑色素瘤患者和25例肾细胞癌患者。49名患者是 可评估的反应，25名黑色素瘤患者和24名患者 肾细胞癌。一名黑色素瘤患者仍在研究中， 尚未对响应进行评估。1例肾细胞癌患者 他的肺转移瘤完全消退，但他的 主要是肾脏。一名黑色素瘤患者对他的 在大脑发育之前持续六个月的皮下疾病 转移。目前还没有看到其他回应。 第一次和第二次治疗后IV级中性粒细胞减少 在随机接受化疗前的患者中发现了拓扑替康的周期 GM-CSF。没有发现对血小板计数有保护作用或不利影响 化疗前应用GM-CSF的患者。