Phase Ib/IIa Study of SLIT Cisplatin by Inhalation in the Treatment of Patients Wtih Relapsed/Progressive Osteosarcoma Metastatic to the Lung
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- The Study Medication Was to be Considered Effective if the Population Response Rate Was Found to be Greater Than 20% and Individuals Who Demonstrated a CR or PR or Whose Tumours Demonstrated a Grade 3 or 4 Histologic Response at the Time of Surgery.
研究概览
简要总结
Phase Ib/IIa open label safety and efficacy study designed to determine the maximum tolerated dose of inhaled cisplatin liposomal (SLIT cisplatin) administered every 14 days to patients with relapsed/progressive osteosarcoma metastatic to the lung.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven, Progressive or recurrent high grade osteosarcoma metastatic to the lung
- •Patients with histologically proven, fully malignant high-grade osteosarcoma of bone
- •Measureable pulmonary metastases
- •Less than grade 3 neuropathies, insignificant decreases in cardiac or auditory function
- •ECOG performance status of 0, 1 or 2
- •FEV1 of 50% or greater of predicted value
- •FEV1/FVC ratio of 65% or greater
- •Serum creatinine of ≤ 1.5 mg/dl
- •Total bilirubin ≤ 1.5mg/dl and SGOT or SGPT < 2.5 times upper normal limit
- •ANC of ≥ 1,000/mm3 and platelet count of ≥ 100,000/mm3
排除标准
- •Grade 3 or higher painful neuropathy persisting after a prior platinum containing regimen
- •Patients who are pregnant or are of childbearing potential and not using methods to avoid pregnancy
- •Concurrent systemic chemotherapy
- •Greater than Grade 2 pulmonary toxicity
- •Pulmonary atelectasis
- •Reactive airway disease which has resulted in hospitalization within the last year or which requires daily treatment with bronchodilator therapy
- •Concurrent serious infections
- •Unstable or serious concurrent medical condition
- •Recent major surgery or thoracic radiation therapy or chemotherapy
- •Significant pulmonary fibrosis secondary to prior radiation
- •Major ventilatory distribution abnormalities
- •Osteosarcoma secondary to radiation or premalignant conditions
- •History of prior malignancy
- •Low grade osteosarcoma, parosteal or periosteal sarcoma
研究组 & 干预措施
Cisplatin liposomal 24 mg/m2
Inhaled liposomal cisplatin was administered over 1 day in a 14-day treatment cycle by inhalation for a maximum of 6 cycles.
干预措施: Cisplatin liposomal (Drug)
Cisplatin liposomal 36 mg/m2
The study allowed for a dose escalation of liposomal cisplatin to 36 mg/m2 if no adverse events of Grade 3 or higher occurred after at least 3 cycles of drug administration at 24 mg/m2
干预措施: Cisplatin liposomal (Drug)
结局指标
主要结局
The Study Medication Was to be Considered Effective if the Population Response Rate Was Found to be Greater Than 20% and Individuals Who Demonstrated a CR or PR or Whose Tumours Demonstrated a Grade 3 or 4 Histologic Response at the Time of Surgery.
时间窗: 4 to 48 weeks
次要结局
未报告次要终点