NCT04571229Available不适用
Expanded Access Use of L-MTP-PE for the Treatment of Osteosarcoma
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- Available
- 试验地点
- 1
研究概览
简要总结
This expanded access protocol will allow access to treatment with L-MTP-PE for people with osteosarcoma. L-MTP-PE is an investigational drug that has not been approved by the FDA to treat any condition, including osteosarcoma. L-MTP-PE works by activating certain types of white blood cells, and these active white blood cells help the immune system kill cancer cells.
研究设计
- 研究类型
- Expanded Access
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of osteosarcoma of any age Note: Patients with either newly diagnosed or relapsed osteosarcoma are eligible.
- •Surgical resection or other definitive local control therapy of all clinically detectable sites of osteosarcoma
- •L-MTP-PE is deemed to be of potential benefit by the treating investigator
- •Willing and able to understand and sign informed consent and assent as appropriate
- •Life expectancy > 6 weeks
- •Adequate organ function as follows:
- •Adequate bone marrow function defined as:
- •absolute neutrophil count (ANC) ≥ 750/mm^3
- •platelet count ≥ 30,000/ mm^3
- •hemoglobin ≥ 8 g/dl
- •Adequate renal function defined as:
- •Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min/1.73m^2 OR
- •Serum creatinine ≤ 2x the upper limit of normal based on age/gender
- •Adequate liver function defined as:
- •Bilirubin (sum of conjugated + unconjugated) ≤ 2x upper limit of normal for age or ≤ 4x upper limit of normal if thought to have Gilbert's disease
- •AST or ALT ≤ 3x upper limit of normal or ≤ 5x upper limit of normal for patients with liver metastases
- •Willing to use a barrier method of contraception throughout the course of the study and for 1 year after participation if relevant
排除标准
- •Use of chronic steroids of other immunosuppressive agents
- •Pregnant or breast feeding
研究者
研究点 (1)
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