Phase II Study Evaluating the Effect of Zolendronic Acid on Standardized Uptake Value (SUV) on FLT PET Scans in Non-Small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- PET Response Rate
研究概览
简要总结
RATIONALE: A positron emission tomography scan is a procedure in which a small amount of radioactive sugar is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where tumor cells are found. This study is looking at whether the drug zoledronic acid interferes with the ability of a PET scan to find tumor cells.
PURPOSE: This phase II trial is studying how well positron emission tomography works when given together with zoledronic acid in finding tumor cells in patients with advanced non-small cell lung cancer.
详细描述
OBJECTIVES:
- Determine the PET response rate after zoledronic acid in patients with non-small cell lung cancer.
OUTLINE: Patients receive 1 dose of zoledronic acid on day 1 followed by 3'-deoxy-3'-[18F]fluorothymidine/PET to determine standardized uptake value.
PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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 or cytologically confirmed non-small cell lung cancer
- •Stage IIIB (with pleural effusion) or stage IV disease
- •Candidate for systemic therapy
- •Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
- •No active brain metastases
- •More than 7 days since prior radiotherapy for brain metastases
- •Must be neurologically stable with no seizures within the past 3 weeks
- •PATIENT CHARACTERISTICS:
- •ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
- •WBC ≥ 3,000/mm³
- •ANC ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •AST or ALT ≤ 2.5 times ULN (5 times ULN if liver metastases present)
- •Creatinine normal OR creatinine clearance ≥ 60 mL/min by Cockcroft-Gault formula
- •No current active dental problems, including infection of the teeth or jawbone (maxilla or mandible)
- •No dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw, of exposed bone in the mouth, or of slow healing after dental procedures
- •Not pregnant
- •No uncontrolled intercurrent illness including, but not limited to, any of the following:
- •Ongoing or active infection
- •Symptomatic congestive heart failure
- •Unstable angina pectoris
- •Cardiac arrhythmia
- •Psychiatric illness/social situations that would limit compliance with study requirements
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No prior or other concurrent bisphosphonates
- •More than 2 weeks since prior surgery
- •More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered
- •More than 7 days since prior palliative radiotherapy and recovered
- •More than 6 weeks since prior and no planned dental or jaw surgery
- •More than 30 days since prior participation in an investigational trial
- •No other concurrent investigational agent
排除标准
- 未提供
研究组 & 干预措施
3'-deoxy-3'-[18F]FLT PET & zoledronic acid
Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid
Single photon emission computed tomography. Patient should receive the dose of zoledronic acid within 48 hrs of the first '3'-deoxy-3'-[18F]FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.
干预措施: 3'-deoxy-3'-[18F]FLT (Other)
3'-deoxy-3'-[18F]FLT PET & zoledronic acid
Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid
Single photon emission computed tomography. Patient should receive the dose of zoledronic acid within 48 hrs of the first '3'-deoxy-3'-[18F]FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.
干预措施: Single photon emission computed tomography (Procedure)
结局指标
主要结局
PET Response Rate
时间窗: FLT PET scan will be done 6-8 days after the dose of zoledronic acid
次要结局
未报告次要终点
研究者
Shirish Gadgeel
Principal Investigator
Barbara Ann Karmanos Cancer Institute