A Phase II Study of Suberoylanilide Hydroxamic Acid and Bortezomib in Advanced Soft Tissue Sarcomas
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 6
- 主要终点
- Confirmed Tumor Responses
研究概览
简要总结
This phase II trial is studying how well giving vorinostat together with bortezomib works in treating patients with advanced soft tissue sarcoma. Vorinostat and bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vorinostat together with bortezomib may kill more tumor cells.
详细描述
PRIMARY OBJECTIVES:
I. To determine the objective response rate in patients with advanced soft tissue sarcoma treated with vorinostat and bortezomib.
SECONDARY OBJECTIVES:
I. Characterize the toxicity of this regimen in these patients. II. Evaluate the progression-free survival and median overall survival of patients treated with this regimen.
OUTLINE:
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
- •Histologically or cytologically confirmed advanced, unresectable, or metastatic soft tissue sarcoma (STS)
- •Measurable disease, defined as >= 1 lesion that can be accurately measured in >= 1 dimension as >= 2 cm by conventional techniques OR >= 1 cm by spiral computed tomography (CT) scan
- •No small round cell tumors, including the following:
- •Primitive neuroectodermal tumor
- •Rhabdomyosarcoma
- •Ewing sarcoma
- •Osteosarcoma
- •No known active and/or untreated brain metastases and/or brain metastases requiring ongoing therapy (e.g., corticosteroids)
- •Treated, inactive brain metastases not requiring ongoing therapy allowed provided the brain metastases have been stable for >= 1 month as assessed by intracranial imaging AND there is no indication of increased vascularity of the treated metastases within 14 days before study entry as assessed by magnetic resonance imaging (MRI)
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 OR Karnofsky PS 70-100%
- •Life expectancy >= 12 weeks
- •Absolute neutrophil count (ANC) >= 1,500/mm^3
- •Platelet count >= 100,000/mm^3
- •Total bilirubin normal
- •Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) =< 2.5 times upper limit of normal
- •Creatinine normal OR creatinine clearance >= 60 mL/min
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Able to take oral medication
- •No peripheral neuropathy >= grade 2
- •No concurrent uncontrolled illness including, but not limited to, any of the following:
- •Ongoing or active infection
- •Symptomatic congestive heart failure
- •Unstable angina pectoris
- •Cardiac arrhythmia or myocardial infarction within the past 6 months
- •Psychiatric illness and/or social situation that would limit compliance with study requirements
- •No history of Torsades de Pointes
- •No history of allergic reactions attributed to compounds of similar chemical or biological composition to vorinostat or bortezomib
- •No more than 1 prior systemic treatment for advanced STS, including investigational agents
- •Adjuvant therapy is not considered a systemic regimen
- •More than 2 weeks since prior valproic acid
- •More than 4 weeks since prior and no concurrent chemotherapy (> 6 weeks for nitrosoureas or mitomycin C) or radiotherapy and recovered
- •Radiotherapy to bone metastasis within the past 2 weeks allowed provided there is active non-bone disease outside the radiation port
- •No prior radiotherapy to >= 33% of the bone marrow
- •No prior vorinostat or bortezomib
- •No concurrent category I medications that are generally accepted to have a risk of causing Torsades de Pointes, including any of the following:
- •Quinidine, procainamide, disopyramide
- •Amiodarone, sotalol, ibutilide, dofetilide
- •Erythromycin, clarithromycin
- •Chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine
- •No concurrent combination antiretroviral therapy for human immunodeficiency virus (HIV)-positive patients
- •No other concurrent investigational agents for the primary malignancy
- •No other concurrent anticancer therapy
排除标准
- 未提供
研究组 & 干预措施
Treatment (vorinostat, bortezomib)
Patients receive 400 mg vorinostat orally once daily on days 1-14. Patients also receive 1.3 mg/m^2 bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: vorinostat (Drug)
Treatment (vorinostat, bortezomib)
Patients receive 400 mg vorinostat orally once daily on days 1-14. Patients also receive 1.3 mg/m^2 bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: bortezomib (Drug)
结局指标
主要结局
Confirmed Tumor Responses
时间窗: Up to 2 years
The number of confirmed tumor responses is defined as a complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) on two consecutive evaluations at least six weeks apart. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest dimension (LD) of target lesions taking as reference the baseline sum LD.
次要结局
- Progression Free Survival(Up to 2 years)
- Overall Survival(Time from registration to death due to any cause, assessed up to 2 years)