NCT00949325已完成1 期
Phase I/II Trial of Torisel and Liposomal Doxorubicin in Patients With Advanced Soft Tissue and Bone Sarcomas
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2009年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Part 1: Incidence of Dose Limiting Toxicities
研究概览
简要总结
The purpose of this study is to identify a safe dosing regimen for the combination of Torisel and liposomal doxorubicin in patients with recurrent sarcoma. A secondary purpose of the study is to determine how effective this combination is for the treatment of recurrent sarcoma.
详细描述
The effectiveness of treatments for recurrent sarcomas is quite limited. One hypothesis to explain the refractory nature of recurrent sarcomas is the existence of chemotherapy-resistant sarcoma stem cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed sarcoma that is recurrent or refractory to conventional treatment
- •Measurable disease by RECIST criteria
- •ECOG (Eastern Cooperative Oncology Group) performance status < 2 (or Lansky/Karnofsky > 60% for children)
- •Life expectancy greater than 3 months
- •Adequate organ function
- •absolute neutrophil count at least 1,500
- •platelets at least 100,000
- •bilirubin less than 1.5 x upper limit of normal
- •AST (aspartate aminotransferase) and ALT(alanine aminotransferase) less than 2.5 x upper limit of normal
- •creatinine less than 1.5 x upper limit of normal OR creatinine clearance at least 60 ml/min/1.73 m2
- •fasting serum cholesterol less than 350
- •fasting serum triglycerides less than 400
- •PT (prothrombin) or INR (international normalized ratio) less than 1.3 x upper limit of normal
- •normal urinalysis
- •Ability to understand and sign the informed consent document
排除标准
- •Prior chemotherapy or radiotherapy within 3 weeks of entering the study (6 weeks for nitrosoureas or mitomycin C)
- •Prior treatment with a tyrosine kinase inhibitor within 10 days of entering the study
- •History of pulmonary hypertension or pneumonitis
- •Patients may not be receiving other investigational agents
- •Prior therapy with rapamycin, rapamycin analogues, or tacrolimus
- •Uncontrolled brain metastases
- •History of grade 3 or 4 hypersensitivity to macrolide antibiotics
- •Concurrent treatment with immunosuppressive agents other than a stable (for more than 2 weeks) dose of corticosteroids
- •Uncontrolled intercurrent illness
- •Pregnancy or breast feeding
- •HIV-positive patients on combination antiretroviral therapy
- •Grade 3 or 4 proteinuria
研究组 & 干预措施
temsirolimus plus liposomal doxorubicin
Experimental
Single arm study: Dose escalation of temsirolimus plus constant dose of liposomal doxorubicin.
干预措施: temsirolimus plus liposomal doxorubicin (Drug)
结局指标
主要结局
Part 1: Incidence of Dose Limiting Toxicities
时间窗: End of second 28-day cycle
Dose limiting toxicities in each dose cohort.
Part 2: Median Overall Survival of Subjects Who Were Treated at the Temsirolimus MTD, 20 mg/m^2
时间窗: up to 5 years
Number of days from day 1 of treatment until date of death from any cause.
次要结局
- Mean Overall Survival of Subjects Who Were Treated at the Temsirolimus MTD, 20 mg/m^2(up to 5 years)
- Maximum Observed Plasma Concentration (Cmax)(Prior to the initial dose on day 1, then 2, 6, and 24 hours post dose; prior to first dose of Cycle 2, then at 1, 2, 6, 24, 96, and 120 hours post dose in patients treated at the recommended phase 2 dose, Dose Level 4.)
- Area Under the Curve (AUC)(Prior to the initial dose on day 1, then 2, 6, and 24 hours post dose; prior to first dose of Cycle 2, then at 1, 2, 6, 24, 96, and 120 hours post dose in patients treated at the recommended phase 2 dose, Dose Level 4.)
- Drug Clearance(Prior to the initial dose on day 1, then 2, 6, and 24 hours post dose; prior to first dose of Cycle 2, then at 1, 2, 6, 24, 96, and 120 hours post dose in patients treated at the recommended phase 2 dose, Dose Level 4.)
- Mean Progression Free Survival of Subjects Who Were Treated at the Temsirolimus MTD, 20 mg/m^2(up to 3 years)
- Median Progression-free Survival of Subjects Who Were Treated at the Temsirolimus MTD, 20 mg/m^2(up to 3 years)
- Objective Response Rate(up to 5 years)
- Duration of Response(up to 5 years)
- Clinical Benefit Rate(up to 5 years)
- Time to Response(up to 5 years)
研究者
研究点 (1)
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