(Inhibition of NF-kB Signaling in Melanoma Therapy) A Phase I/II Clinical Trial of PS-341, a Proteasome Inhibitor, in Combination With an Extended Continuous Oral Schedule of Temozolomide in Patients With Advanced Refractory Solid Tumors With the Phase II Component Only in Patients With Melanoma
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Optimal Doses of Temozolomide and Bortezomib (Phase I)
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or stopping them from dividing. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving temozolomide together with bortezomib may kill more tumor cells.
PURPOSE: To determine the best dose of bortezomib and temozolomide and to see how well they work in treating patients with advanced refractory solid tumors or melanoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Phase I
干预措施: PS-341 (VELCADE) (Drug)
Phase I
干预措施: Temozolomide (Drug)
Phase I
干预措施: immunoenzyme technique (Other)
Phase II
干预措施: PS-341 (VELCADE) (Drug)
Phase II
干预措施: Temozolomide (Drug)
结局指标
主要结局
Optimal Doses of Temozolomide and Bortezomib (Phase I)
时间窗: up to 42 days
The optimal biologic dose (OBD) defined as the dose that achieves the greatest degree of inhibition of NF-κB activation in peripheral blood mononuclear cells when co-administered with Temozolomide
Number of Patients With Clinical Anti-tumor Activity Phase II)
时间窗: every 9 weeks to a maximum of 54 weeks
Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) \> 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) \> 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions. Patients with CR + PR + SD
次要结局
- Patients With Inhibition in NF-kB Activation (Phase I)(at baseline, on day 8 and on day 29)
- Patients With Clinical Anti-tumor Activity (Phase I)(every 9 weeks up to a maximum of 54 weeks)
- Patients With Inhibition of NF-kB (Phase II)(at baseline, on day 8 and on day 29)
研究者
Jeffrey A. Sosman, MD
Professor of Medicine; Director, Melanoma and Tumor Immunotherapy Program; Medical Oncologist
Vanderbilt-Ingram Cancer Center