PHASE 2 STUDY OF FLT3 LIGAND (FLT3) IN METASTATIC MELANOMA PATIENTS

该研究是一项开放标签、多中心、II期研究，旨在通过皮下注射Flt3配体治疗转移性黑色素瘤患者。既往未接受治疗的转移性疾病（生长缓慢，体积小）和既往治疗方案失败的转移性疾病患者将符合本研究的条件。该研究的目的是评估Flt3L作为转移性黑色素瘤患者免疫治疗药物的安全性和有效性。全国将有340名患者进入该研究；10人将通过匹兹堡大学癌症研究所（UPCI）入学。患者将接受每日25ug/kg Flt3L的SC剂量，连续14天，共6个周期。每个周期为28天。所有接受至少一剂研究药物的患者都将进行安全性评估。所有接受两个周期研究药物并进行两周随访（研究期间为8周）的患者将评估肿瘤反应。所有接受至少一个周期（14天）研究药物并进行两周随访（研究期间为四周）的患者将评估免疫活性。

This study is an open-label, multi-center, Phase II study investigating the use of Flt3 Ligand via subcutaneous (SC) injection to treat patients with metastatic melanoma. Patients with previously untreated metastatic disease (slow growing, small volume) and those who have failed one prior treatment regimen for metastatic disease will be eligible for this study. The study's objectives are to evaluate the safety and efficacy of Flt3L as an immunotherapy agent in patients with metastatic melanoma. Thirty-40 patients will enter the study nationwide; 10 will be enrolled through the University of Pittsburgh Cancer Institute (UPCI). Patients will receive a daily SC dose of 25ug/kg of Flt3L for 14 consecutive days, for six cycles. Each cycle will consist of 28 days. All patients who receive at least one dose of study drug will be evaluated for safety. All patients who receive two cycles of the study drug with two weeks of follow up (eight weeks on study) will be evaluated for tumor response. All patients who receive at least one cycle (14 days) of the study drug with two weeks of follow up (four weeks on study) will be evaluated for immunologic activity.