NCT00962507已完成1 期
A Phase I Study Evaluating the Combination of the Deacetylase Inhibitor, LBH589 Plus the mTOR Inhibitor RAD001, in Relapsed and Refractory Adult Patients With Lymphoma
City of Hope Medical Center4 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2009年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 4
- 主要终点
- Maximum tolerated dose
研究概览
简要总结
RATIONALE: Panobinostat and everolimus 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. Giving panobinostat together with everolimus may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of panobinostat when given together with everolimus in treating patients with relapsed or refractory lymphoma or multiple myeloma.
详细描述
OBJECTIVES:
Primary
- To evaluate the safety and feasibility of combining panobinostat with everolimus in patients with recurrent or refractory lymphoma or multiple myeloma.
- To define the maximum tolerated dose of panobinostat in combination with everolimus in these patients.
Secondary
- To obtain preliminary data for response to this treatment regimen in these patients.
- To perform correlative studies relevant to this treatment regimen.
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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed diagnosis of one of the following:
- •Hodgkin or non-Hodgkin lymphoma (including small lymphocytic lymphoma [SLL])
- •Any histology, including B, T, or NK/T cell allowed
- •Multiple myeloma (MM)
- •Relapsed or refractory disease
- •Patients with lymphoma must have relapsed after or be refractory to an upfront regimen (e.g., CHOP or ABVD) and a salvage regimen (e.g., ICE or ESHAP)
- •Patients with SLL should have relapsed after a fludarabine-containing regimen
- •Patients with MM must have progressed within 100 days after receiving a regimen containing bortezomib and either thalidomide or lenalidomide AND have a 25% increase in serum paraproteins, urinary light chains, or plasma cell number in the bone marrow
- •No active CNS disease
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •ANC ≥ 1,500/mm³
- •Platelet count ≥ 75,000/mm³ (transfusion allowed in patients with biopsy-proven bone marrow involvement)
- •AST and ALT ≤ 2.5 times upper limit of normal (ULN) (≤ 5.0 times ULN if elevation due to leukemic involvement)
- •Serum bilirubin ≤ 1.5 times ULN
- •Serum creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 50 mL/min
- •Serum potassium normal
- •Serum phosphorous normal
- •Serum total calcium (corrected for serum albumin) or serum ionized calcium normal
- •Serum magnesium normal
- •TSH and free T4 normal (thyroid hormone replacement allowed)
- •Fasting serum cholesterol ≤ 300 mg/dL (or ≤ 7.75 mmol/L) AND fasting triglycerides ≤ 2.5 times ULN (elevated levels allowed provided an appropriate lipid-lowering medication has been initiated)
- •LVEF normal by MUGA or ECHO
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective double-method (including barrier method) contraception during and for 3 months after completion of study treatment
- •No impaired cardiac function, including any of the following:
- •QTc > 450 msec by screening ECG
- •Congenital long QT syndrome
- •History of sustained ventricular tachycardia
- •History of ventricular fibrillation or torsades de pointes
- •Bradycardia, defined as heart rate (HR) < 50 beats/min (pacemaker allowed provided HR ≥ 50 beats/min)
- •Myocardial infarction or unstable angina within the past 6 months
- •NYHA class III-IV congestive heart failure
- •Right bundle branch block and left anterior hemiblock (bifascicular block)
- •No uncontrolled hypertension
- •No unresolved diarrhea > CTCAE grade 1
- •No impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral agents (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
- •No other concurrent severe or uncontrolled medical condition
- •No other primary malignancy within the past 5 years other than curatively treated carcinoma in situ of the cervix or basal cell or squamous cell carcinoma of the skin
- •No known HIV or hepatitis C positivity
- •No significant history of non-compliance to medical regimens
- •No known hypersensitivity to everolimus, other rapamycins (e.g., sirolimus or temsirolimus), or their excipients
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Prior autologous or allogeneic stem cell transplantation allowed
- •More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) or radiotherapy and recovered
- •More than 1 week since prior and no concurrent immunization with live attenuated vaccines
- •More than 4 weeks since prior valproic acid
- 另有 10 项未显示
排除标准
- 未提供
结局指标
主要结局
Maximum tolerated dose
时间窗: 90 days post treatment start
Toxicity
时间窗: 90 days post treatment start
次要结局
- Pharmacokinetic and correlative studies(Day 1 and Day 26 of the first cycle of treament)
研究者
研究点 (4)
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