Phase II Study of PXD101 (NSC-726630) in Relapsed and Refractory Aggressive B-Cell Lymphomas
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 123
- 主要终点
- Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)
研究概览
简要总结
This phase II trial is studying how well PXD101 works in treating patients with relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma. PXD101 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer.
详细描述
PRIMARY OBJECTIVES:
I. Evaluate response rate in patients with relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma treated with PXD101.
SECONDARY OBJECTIVES:
I. Determine the toxicity of this drug in these patients. II. Estimate the 6-month progression-free survival rate in patients treated with this drug.
TERTIARY OBJECTIVES:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy-proven (no needle aspirations or cytologies) aggressive B-cell non-Hodgkin's lymphoma (NHL), including 1 of the following histology subtypes:
- •Diffuse large cell NHL
- •Burkitt's or Burkitt-like NHL
- •Primary mediastinal NHL
- •Relapsed or refractory disease
- •Bidimensionally measurable disease
- •Transformed NHL allowed
- •Not eligible for stem cell transplantation (for patients registered to study at first relapse)
- •No active CNS involvement by lymphoma
- •Zubrod performance status 0-2
- •No history of allergic reactions attributed to compounds of similar chemical or biologic composition to PXD101
- •Absolute neutrophil count >= 1,500/mm^3
- •Platelet count>=100,000/mm^3
- •WBC >= 3,000/mm^3
- •Creatinine < 2 times upper limit of normal (ULN) OR creatinine clearance >= 60 mL/min
- •No significant EKG abnormalities
- •Bilirubin normal
- •SGOT/SGPT < 2.5 times ULN (=< 5 times ULN if liver involvement)
- •No long QT syndrome or marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of QTc interval > 500 msec)
- •No other significant cardiovascular disease, including any of the following:
- •Unstable angina pectoris
- •Uncontrolled hypertension
- •Congestive heart failure related to primary cardiac disease
- •Any condition requiring anti-arrhythmic therapy
- •Ischemic or severe valvular heart disease
- •Myocardial infarction within the past 6 months
- •No major surgery within 28 days prior to study entry
- •No concurrent combination antiretroviral therapy for HIV-positive patients
- •No concurrent medication that may cause Torsades de Pointes (i.e., prolongation of the QT interval > 500 msec)
- •At least 14 days since prior radiotherapy
- •At least 2 weeks since prior valproic acid or any other histone deacetylase inhibitor
- •No clinical evidence of any of the following:
- •Severe peripheral vascular disease
- •Diabetic ulcers or venous stasis ulcers
- •History of deep venous or arterial thrombosis within the past 3 months
- •Radioimmunotherapy is considered a chemotherapy regimen
- •Single-agent rituximab is not considered a chemotherapy regimen
- •Standard salvage chemotherapy followed by autologous stem cell transplantation is considered 1 regimen
- •No known AIDS or HIV-associated complex
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or in situ carcinoma of the cervix
- •At least 2 weeks since prior therapy and recovered
- •No more than 5 prior chemotherapy regimens
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients will receive an infusion of PXD101 once a day for 5 days. Treatment may repeat every 3 weeks for up to 2 years. Some patients will also undergo core biopsy and blood collection for laboratory studies before and after treatment.
After finishing treatment, patients will be evaluated every 3-6 months for up to 3 years.
干预措施: belinostat (Drug)
结局指标
主要结局
Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)
时间窗: assessed at week 8, and every 3 months for 3 years
Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the SPD for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.
次要结局
- Overall Survival(assessed every 3 months for 3 years)
- Progression-free Survival(assessed at week 8, then every 3 months for 3 years)