NCT00776373终止1 期
A Phase I/II, Open-label Single Institution Study Evaluating Rapamycin in Combination With High-dose Etoposide and Cytarabine in Relapsed or Refractory Aggressive Lymphoid Malignancies
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Safety, tolerability and efficacy of rapamycin in combination with HiVAC in relapsed and refractory patients with aggressive lymphoid malignancies
研究概览
简要总结
Assess the safety, tolerability and efficacy of rapamycin in combination with HiVAC in relapsed and refractory patients with aggressive lymphoid malignancies.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced lymphoid leukemia (primary refractory ALL; Relapsed ALL; CML in lymphoid accelerated phase or blast crisis; relapsed or refractory Burkitt's lymphoma; relapsed or refractory T-cell adult leukemia/lymphoma; relapsed or refractory lymphoblastic lymphoma
- •>= 18 and <= 65 years of age ECOG performance status 0, 1 Life expectancy >= 4 weeks Able to consume oral medication Required initial laboratory values: Creatinine <= 2.0mg/dL, total or direct bilirubin <= 1.5 mg/dL, SGPT(ALT) <=ULN, glucose < 200 mg/dL, negative pregnancy test for women with child bearing potential
排除标准
- •Subjects must not be receiving any chemotherapy agents (except Hydroxyurea)
- •Subjects must not have received high-dose Ara-C within 6 months of relapse
- •Subjects must not be receiving growth factors, except for erythropoietin
- •No currently active second malignancy other than non-melanoma skin cancers
- •No subjects with uncontrolled high blood pressure, unstable angina, symptomatic congestive heart failure, MI within the last 6 months or serious uncontrolled cardiac arrhythmia
- •Subjects taking Carbamazepine, Rifabutin, Rifampin, Rifapentine, St. John's wort, Clarithromycin, Cyclosporine, Diltiazem, Erythromycin, Telithromycin, Verapamil, Tacrolimus
- •Known HIV positivity or AIDS-related illness
- •Evidence of cerebellar dysfunction or prior history of cerebellar dysfunction with Ara-C administration
- •Pregnant or lactating
- •Uncontrolled infection
- •Taking fluconazole, voriconazole, itraconazole and ketoconazole currently or within one week of study entry
研究组 & 干预措施
Arm 1
Experimental
Rapamycin in combination with High Dose Etoposide and Cytarabine (HiVAC)
干预措施: Rapamycin (Drug)
Arm 1
Experimental
Rapamycin in combination with High Dose Etoposide and Cytarabine (HiVAC)
干预措施: High dose etoposide and cytarabine (HiVAC) (Drug)
结局指标
主要结局
Safety, tolerability and efficacy of rapamycin in combination with HiVAC in relapsed and refractory patients with aggressive lymphoid malignancies
时间窗: Study completion
次要结局
- Whether increased mTOR pathway inhibition correlates with response to therapy with rapamycin and HiVAC(Study completion)
- Assess and quantify phosphorylation of p70S6 kinase(Study completion)
研究者
研究点 (1)
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