Phase II Combination of 131I-Omburtamab Radioimmunotherapy and External Beam Radiotherapy for Desmoplastic Small Round Cell Tumor
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Progression Free Survival/PFS
研究概览
简要总结
The purpose of this study is to test any good and bad effects of the study drug 131I-omburtamab. 131I-omburtamab could prevent the cancer from returning, or delay the cancer from getting worse, but it could also cause side effects. Researchers hope to learn more about how 131I-omburtamab works in the body, and how effective it is in treating cancer. 131I-Omburtamab is not approved by the FDA to treat DSRCT or other cancers of the peritoneum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have the diagnosis of DSRCT confirmed at MSKCC
- •Age >1 year and able to cooperate with radiation safety restrictions during therapy period.
- •Prior to intraperitoneal catheter placement
- •At least 1 weeks must have elapsed since prior chemotherapy
- •At least 2 weeks must have elapsed since biologic therapy
- •Toxicities of prior therapy must have resolved to grade 1 or less or to the patient's baseline
- •At the completion of surgery, patients must fulfill all of the additional following criteria:
- •Have no definitive radiological evidence of disease active in liver or outside the abdomen/pelvic OR have had GTR of this disease at the time of catheter placement
排除标准
- •Prior progression of disease
- •Prior hypothermic intraperitoneal chemotherapy (HIPEC)
- •Cardiac, pulmonary, and neurologic toxicities are greater grade 1 per NCI CTCAE version 5
- •Renal, gastrointestinal, and hepatic, toxicities are greater than grade 2 (per NCI CTCAE version 5)
- •History of allergy to mouse proteins
- •Patients with grade 4 hypersensitivity reaction to radiolabeled iodine
研究组 & 干预措施
Group A
Participants with DSRCT who have undergone GTR of their abdominopelvic disease and who have no definitive radiological evidence of disease in liver or outside the abd/pelvis. Patients if deemed of likely benefit to the patient after completing IP RIT plus WAP-IMRT, or will be mandated if ANC is persistently <500/ul despite use of G-CSF for >1 week, or if patients experience life threatening febrile neutropenia.
干预措施: 131 I-omburtamab (Drug)
Group C
Participants with tumors other than DSRCT and will be enrolled onto an assessment arm to determine eligibility. Immunohistochemistry to assess B7H3 expression will be performed on frozen or paraffin embedded tissue using omburtamab (frozen tissue) or a commercially available anti-B7H3 antibody (if paraffin embedded).
干预措施: 131 I-omburtamab (Drug)
Group A
Participants with DSRCT who have undergone GTR of their abdominopelvic disease and who have no definitive radiological evidence of disease in liver or outside the abd/pelvis. Patients if deemed of likely benefit to the patient after completing IP RIT plus WAP-IMRT, or will be mandated if ANC is persistently <500/ul despite use of G-CSF for >1 week, or if patients experience life threatening febrile neutropenia.
干预措施: WAP-IMRT (Radiation)
Group B
DSRCT patients who have macroscopic residual disease OR who have previously experienced progression of disease while on treatment but have subsequently had a GTR
干预措施: 131 I-omburtamab (Drug)
结局指标
主要结局
Progression Free Survival/PFS
时间窗: Up to 2 years after treatment is discontinued
Progression free survival after RIT + WA-IMRT.
次要结局
未报告次要终点