Combination of External Beam Radiotherapy With 153Sm-EDTMP to Treat High Risk Osteosarcoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Percentage of Treated Participants With 6-month Progression Free Survival
研究概览
简要总结
The primary goal of this study will be to examine tumor response after radiation treatment via a combination of Samarium-153 EDTMP and external beam radiotherapy.
详细描述
Samarium tracer infusion of 1 mCi/kg administered. SPECT images wil be used to determine the distribution of dose delivered to the tumor. This information will be used to determine target doses of external beam radiotherapy. The treatment infusion of Samarium, 30 mCi/kg, will be administered and dosimetry will confirm total dose delivered, and information will be used to finalize doses of external beam radiotherapy. Approximately 14 days after treatment infusion, autologous stem cells infusion is administered. Radiotherapy will be delivered according to the judgement of the treating radiation oncologist.
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
- 10 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be between 13 and 65 years of age, inclusive
- •Must have unresectable primary tumor or metastases
- •Must have measurable disease that is demonstrated by positive Tc-99m Bone Scan. Not all lesions must be positive on bone scan.
- •Creatinine clearance >70ml/min/1.73m2
- •ANC >500/mm3
- •Platelets >50,000/mm3
- •Life expectancy > 8 weeks
- •Karnofsky performance status >50%
- •Stem cell product collected prior to the infusion of Samarium must be available, either by peripheral stem cell mobilization or bone marrow harvest prior to trial entry.
排除标准
- •Patient may not be pregnant or breastfeeding.
- •Patients who have received prior radiotherapy to all areas of current active disease are not eligible.
研究组 & 干预措施
SmEDTMP/Autologous Stem Cell Infusion/RT
DAY 1 Tracer dose 153Sm-EDTMP administration (1 mCi/kg) SPECT/High-resolution CT at 4 hours. SPECT/CT (low resolution) at 24 and 48 hrs
DAY 7 Individualized treatment dose 153Sm-EDTMP administration (max 30 mCi/kg) SPECT scans at 4, 24 and 48 hours
DAY 21 (2 weeks following treatment dose) Auto-Stem cell infusion
DAY 40 (approx. two weeks after stem cell rescue) Initiate EBT upon count recovery
1 MONTH following completion of all therapy Response assessment with repeat imaging (CT/MRI, Tc-99m bone scan) 18F-MISO/FDG PET
干预措施: Sm-EDTMP (Drug)
SmEDTMP/Autologous Stem Cell Infusion/RT
DAY 1 Tracer dose 153Sm-EDTMP administration (1 mCi/kg) SPECT/High-resolution CT at 4 hours. SPECT/CT (low resolution) at 24 and 48 hrs
DAY 7 Individualized treatment dose 153Sm-EDTMP administration (max 30 mCi/kg) SPECT scans at 4, 24 and 48 hours
DAY 21 (2 weeks following treatment dose) Auto-Stem cell infusion
DAY 40 (approx. two weeks after stem cell rescue) Initiate EBT upon count recovery
1 MONTH following completion of all therapy Response assessment with repeat imaging (CT/MRI, Tc-99m bone scan) 18F-MISO/FDG PET
干预措施: Autologous Stem Cell Infusion (Other)
SmEDTMP/Autologous Stem Cell Infusion/RT
DAY 1 Tracer dose 153Sm-EDTMP administration (1 mCi/kg) SPECT/High-resolution CT at 4 hours. SPECT/CT (low resolution) at 24 and 48 hrs
DAY 7 Individualized treatment dose 153Sm-EDTMP administration (max 30 mCi/kg) SPECT scans at 4, 24 and 48 hours
DAY 21 (2 weeks following treatment dose) Auto-Stem cell infusion
DAY 40 (approx. two weeks after stem cell rescue) Initiate EBT upon count recovery
1 MONTH following completion of all therapy Response assessment with repeat imaging (CT/MRI, Tc-99m bone scan) 18F-MISO/FDG PET
干预措施: External Beam Radiotherapy (Radiation)
结局指标
主要结局
Percentage of Treated Participants With 6-month Progression Free Survival
时间窗: 6 months post-intervention
Percentage of patients with high-risk osteogenic sarcoma, treated with high-dose Samarium-153 EDTMP and external beam radiotherapy, without progression at 6 months.
次要结局
- Short and Long-term Side Effects of Combined Infusional Samarium-153 EDTMP and External Beam Radiotherapy as Assessed by Number of Participants With Toxicity(Up to 48 months)