Phase 2 Study of Inhaled Lipid Cisplatin in Pulmonary Recurrent Osteosarcoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 15
- 主要终点
- Observed Relapse Free Interval (RFI)
研究概览
简要总结
To establish whether treatment with Inhaled Lipid Cisplatin (ILC) is effective in delaying/preventing pulmonary relapse in osteosarcoma patients in complete surgical remission following one or two prior pulmonary relapses.
详细描述
ILC is a novel formulation of cisplatin, designed for inhalation by nebulization. The anticipated pulmonary benefits of ILC over systemic cisplatin therapy are threefold:
- Increased local cisplatin concentrations
- Sustained release of cisplatin in the lungs
- Minimal systemic exposure to cisplatin
In this study, patients currently in surgical complete remission (CR) following one or two prior relapses of osteosarcoma involving pulmonary disease will be treated with ILC every two weeks for up to one year. ILC will be administered via nebulization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of osteosarcoma metastatic to the lung(s). (First or second pulmonary recurrence(s) removed by surgery, and previous second-line systemic chemotherapy is allowed).
- •Patients must be macroscopically disease free following pulmonary metastectomy of a single or multiple lesions. Complete remission surgically (free of macroscopic disease) is required. Pleural disruption and/or microscopic positive margins are allowed.
- •Age ≥13 years.
- •Patients must have recovered sufficiently from all acute adverse effects of prior therapies, excluding alopecia.
- •Patients must have an ECOG performance status of 0-
- •(Lansky score of 50-100 if < 16 years old).
- •Patients must have recovered sufficiently from surgery and have adequate airflow and pulmonary reserve. This decision should be at the investigator's discretion taking into consideration pre-surgery pulmonary function. (As a guideline: adequate airflow defined by a measured Forced Expiratory Volume (FEV1) not less than 50% of the predicted value and adequate pulmonary reserve as evidenced by a FEV1/FVC ratio of 65% or greater).
- •Patients must have adequate renal function as defined by a serum creatinine of ≤ 1.5 mg/dl.
- •Patients must have adequate liver function as defined by total bilirubin of ≤ 1.5 mg/dl and ALT or AST < 2.5 times the institution's upper normal limit.
- •Patients must have adequate bone marrow function as defined by an absolute neutrophil count (ANC) of ≥ 1,000/mm3 and platelet count of ≥ 100,000/mm
- •Signed informed consent including, where applicable, the consent of the patient's legal guardian.
排除标准
- •Current extrapulmonary disease.
- •Current macroscopic pulmonary lesions.
- •Greater than 2 pulmonary recurrences.
- •Greater than 4 weeks since thoracotomy rendering patient free of macroscopic disease.
- •Females who are pregnant or breast-feeding.
- •Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the patient in this study.
- •Contraindication to or unwillingness to undergo multiple CT scans and chest X-rays.
- •Unwillingness or inability to comply with the study protocol for any other reason.
- •Participation in an investigational drug or device study or treatment with any anti-neoplastic agent within 14 days of the first day of dosing on this study
研究组 & 干预措施
ILC
Inhaled Lipid Cisplatin (ILC) will be administered every two weeks via nebulization and inhalation.
干预措施: Inhaled Lipid Cisplatin (ILC) (Drug)
结局指标
主要结局
Observed Relapse Free Interval (RFI)
时间窗: At relapse, estimated at 6-12 months average.
Observed relapse free interval (RFI) will be compared to historical controls. Relapse free interval is defined as the time of diagnosis of the previous relapse to time of diagnosis of the new relapse.
次要结局
- Median, 1, 2 and 5 year Overall Survival (OS)(1, 2 and 5 Years)
- Median, 1, 2 and 5 year Event Free Survival (EFS)(1, 2 and 5 years)