A Pilot Phase 2 Study of Bisphosphonate Therapy (Zoledronic Acid) in Patients With Advanced Malignant Mesothelioma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Tumor Response Rate Following Zoledronic Acid (Zometa)
研究概览
简要总结
The primary objective of this trial is to determine the response rate of single agent zoledronic acid using a composite of criteria including the EORTC modified RECIST criteria and the EORTC tumor response criteria for 18F-FDG PET scans.
详细描述
This pilot study will examine the effect of bisphosphonate (zoledronic acid) in patients with malignant mesothelioma. Evaluation will be limited to patients with standard (CT scans) and functional instruments (FDG PET Scans) of tumor assessment after the administration of standard doses of zoledronic acid (4 mg IV every 3 weeks). We will also explore the biologic effect of zoledronic acid in patients using new serum markers as well as several blood level markers.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females > 18 years of age
- •Life expectancy of at least 2 months
- •Histologically confirmed unresectable malignant pleural mesothelioma (MPM)
- •Measurable disease by CT Scan criteria and/or positive metabolic activity of 18F-FDG PET Scan criteria at screening
- •ECOG Performance Status of 0-2
- •Laboratory and clinical results within 2 weeks prior to Day 1 must be as follows:
- •ANC ≥ 1.5 x 109/L
- •Platelet Count ≥ 100 x 109/L
- •Hemoglobin ≥ 9g/dL
- •Serum bilirubin ≤ 1.5 x upper limit of normal (ULN)
- •AST ≤ 2.5 x ULN
- •ALT ≤ 2.5 x ULN
- •ALK-P ≤ 3 x ULN
- •Serum creatinine ≤ 1.8mg/dL
- •Calculated Serum Creatinine Clearance 40 - > 60ml/min
- •Female subjects of childbearing potential and all male subjects must be surgically sterile or consent to use a medically acceptable method of contraception throughout the trial.
- •Willing and able to provide written informed consent.
排除标准
- •Known central nervous system (CNS) tumor involvement
- •Evidence of other active malignancy requiring treatment
- •Clinically significant heart disease (e.g., congestive heart failure of New York Heart Association Class 3 or 4 angina not well controlled by medication, or myocardial infarction within 6 months)
- •Known infection with HIV or hepatitis
- •Clinically significant arrhythmias demonstrated on electrocardiogram (ECG). Note: subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia (SVT) are eligible.
- •Active, serious systemic disease, including active bacterial or fungal infection.
- •Subjects undergoing invasive dental procedures, significant periodontal disease or history of osteonecrosis of the jaw.
- •Treatment within 4 weeks of the start of the trial with other systemic anticancer therapy.
- •Breastfeeding, pregnant, or likely to become pregnant during the clinical trial.
研究组 & 干预措施
Zometa
Zometa (zoledronic acid) will be administered by infusion on Day 1 of a 3-week cycle followed by tumor assessment from CT and/or PET scans every 2 cycles. This will continue until progression of disease and/or intolerable toxicity.
干预措施: Zometa (Drug)
结局指标
主要结局
Tumor Response Rate Following Zoledronic Acid (Zometa)
时间窗: Baseline up to 28 months or until progressive disease or death
The modified Response Evaluation Criteria in Solid Tumors Criteria (RECIST 2004) will be used for target lesions and assessed by CT scans. Complete Response (CR) is the disappearance of target lesions; Partial Response (PR) is greater than or equal to 30% reduction in the total tumor measurement; Stable Disease (SD) is the absence of response or progression; and Progressive Disease (PD) is a 20% increase in the total tumor measurement over nadir value or the appearance of new lesions.
次要结局
- Progression Free Survival (PFS)(Baseline up to 28 months)
- Overall Survival (OS)(Baseline up to 28 months)
研究者
Francisco Robert,MD
Professor
University of Alabama at Birmingham