NCT01386398撤回3 期
Progression Free Survival (PFS) Comparison Between Suberoylanilide Hydroxamic Acid (SAHA, Vorinostat TM) in Combination With Bortezomib (Velcade TM) and SAHA Alone in Refractory or Recurrent Advanced CTCL. A Randomized Study.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Progression-free survival
研究概览
简要总结
RATIONALE: Vorinostat and bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether vorinostat is more effective when given alone or when given together with bortezomib in treating patients with refractory or recurrent cutaneous T-cell lymphoma.
PURPOSE: This randomized phase III trial is studying how well vorinostat works when given alone compared with vorinostat given together with bortezomib in treating patients with refractory or recurrent stage IIB, stage III, or stage IV cutaneous T-cell lymphoma.
详细描述
OBJECTIVES:
Primary
- To determine if the combination of bortezomib plus vorinostat (SAHA) is more effective than vorinostat alone, in terms of prolonging progression-free survival, in patients with stage IIB-IV cutaneous T-cell lymphoma who have failed prior therapy.
Secondary
- To determine the overall survival of these patients.
- To determine the response rate in these patients.
- To determine the time to progression in these patients.
- To determine the duration of response in these patients.
- To determine the incidence of second cancers in these patients.
- To determine the acute and late toxicity of this regimen in these patients.
- To determine if translational research may provide insight into disease mechanism and identify biomarkers useful for prediction of treatment response. (Exploratory)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed advanced cutaneous T-cell lymphoma (CTCL), including its variants mycosis fungoides and Sézary syndrome
- •Stage IIB-IV disease
- •Relapsed or refractory disease, including any of the following:
- •Patients with clinical progression following EORTC-21081 protocol treatment
- •Intolerant to ≥ 1 prior intravenous chemotherapy, including denileukin diftitox, antibodies or antibody conjugates, or any other systemic therapy
- •No CNS involvement
- •PATIENT CHARACTERISTICS:
- •WHO performance status 0-2
- •Absolute neutrophil count > 1.5 x 10^9/L*
- •Platelet count > 100 x 10^9/L*
- •Hemoglobin > 9 g/dL*
- •WBC > 3 x 10^9/L*
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)*
- •AST and ALT ≤ 3 times ULN (in case of liver infiltration ≤ 5 x ULN)*
- •Serum creatinine ≤ 2.0 mg/dL*
- •Calculated creatinine clearance ≥ 60 mL/min
- •Electrolytes (including potassium and magnesium) ≤ 1 times ULN*
- •Not pregnant or nursing prior to the first dose of study treatment and until 4 weeks after the last study treatment
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after completion of study therapy
- •Able to swallow capsules and is able to take or tolerate oral medication on a continuous basis
- •No New York Heart Association class III-IV disease
- •None of the following known conditions:
- •Infectious disease
- •Autoimmune disease
- •Immunodeficiency
- •No known or active HIV and/or hepatitis A, B, or C infection
- •No NCI CTC grade 1 peripheral sensory neuropathy with pain or peripheral sensory or motor neuropathy ≥ grade II
- •No other malignancy within the past 5 years
- •No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule NOTE: *Patients with a buffer range from the normal values of +/- 5% for hematology and +/- 10% for biochemistry are acceptable, except for renal function.
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Must have completely recovered from previous treatment toxicity
- •No prior splenectomy or splenic irradiation
- •No prior bortezomib and/or histone deacetylase inhibitors (including vorinostat [SAHA])
- •More than 4 weeks since prior chemotherapy, immunotherapy, radiotherapy, or surgery
- •In case of clear progression during previous treatment, 2 weeks of wash-out is enough
- •No concurrent chemotherapy, immunotherapy, radiotherapy, or surgery (except biopsies)
- •No concurrent steroid (prednisone or equivalent) dose > 20 mg/day
- •Prednisone ≤ 20 mg/day for treatment of disorders other than CTCL allowed
- •No concomitant use of other histone deacetylase inhibitors (e.g., valproic acid)
排除标准
- 未提供
结局指标
主要结局
Progression-free survival
次要结局
- Time to progression
- Duration of response
- Second cancers
- Acute and late toxicity
- Overall survival
- Response rate
研究者
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