NCT01099644终止1 期
Phase I Study of Intraperitoneal Radioimmunotherapy With 131I-8H9 for Patients With Desmoplastic Small Round Cell Tumors and Other Solid Tumors Involving the Peritoneum
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Define the toxicity of 131I-8H9 administered intraperitoneally.
研究概览
简要总结
A phase I study of Intraperitoneal Radioimmunotherapy with 131 I-omburtamab in patients >1 year of age with desmoplastic small round cell tumors and other solid tumors involving the peritoneum.
详细描述
The purpose of this study is to test the safety of a new medicine called antibody 8H9 injected into the lining of the abdomen or peritoneum, where the tumor is. This medicine is an antibody or protein which binds to certain tumors, including DSCRT. There is a small number of DSCRT which do not bind with 8H9. If the tumor does not bind with 8H9, you might not benefit from this treatment. The investigators want to find out what effects, good and/or bad, it has.
This antibody is made in mice. Radioactive iodine can be bound to this antibody to deliver radiation to the tumor. The investigators wish to determine the safety of radiolabeled 8H9 at different dose levels. This is the first study using 131I-8H9 in the peritoneum.
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
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have the diagnosis of (a) DSRCT with peritoneal involvement or (b) other Burtomab-positive solid tumors involving the peritoneum (e.g. adrenocortical carcinoma, Wilm's tumor).
- •For tumors other than DSRCT, patients must have a history of tumor progression or recurrence or failure to achieve complete response with standard therapy or <20% chance of long term disease-free survival.
- •For tumors other than DSRCT, Burtomab reactivity must be confirmed by immunohistochemistry.
- •Patients with DSCRT are not required to have measurable or evaluable disease.
- •Patients with tumors other than DSRCT without measurable or evaluable disease will only be considered if they have <20% chance of long term disease-free survival.
- •Prior Therapy: At least 4 weeks should have elapsed since any biologic therapy, or immunotherapy. Three weeks should have elapsed since last dose of chemotherapy or radiotherapy.
- •Age >1 year and able to cooperate with radiation safety restrictions during therapy period.
- •Stem cells: Patients must have an autologous hematopoietic stem cell product cryopreserved and available for re-infusion after 131 I-Burtomab treatment. The minimum dose for hematopoietic stem cells is 2 x 106 CD34+ cells/kg.
- •Minimum life expectancy of six weeks as determined by consenting professional.
- •Signed informed consent indicating awareness of the investigational nature of this program.
排除标准
- •Severe major organ toxicity. Renal, cardiac, hepatic, pulmonary, gastrointestinal and neurologic toxicity should all be grade 1 or less (per NCI CTC version 3 criteria) with the following exceptions: serum AST,ALT and alkaline phosphatase should be ≤5 x upper limit of normal (ULN), serum bilirubin ≤ 3 x ULN and nausea and vomiting should be ≤ grade 2 Patients with myelosuppression are not excluded if ANC ≥ 500/uL.
- •Platelet count should be > 50,000/ul and hemoglobin should be > 8gm/dl. Patients may receive platelet or red blood cell transfusions to maintain hemoglobin and platelets at clinical appropriate levels.
- •Patients with clinically suspected dense intraperitoneal adhesions preventing adequate IP distribution.
- •History of allergy to mouse proteins.
- •Patients previously treated with murine monoclonal antibodies will be excluded if they have a HAMA level of >1000U/ml.
- •Active serious infections not controlled by antibiotics.
- •Pregnant women and women who are breast feeding are excluded for fear of danger to the fetus/infant. Therefore negative pregnancy test is required for all women of child-bearing age, and appropriate contraception is used during the study period. Pregnancy testing will be carried out within two weeks prior to administration of radioiodinated Burtomab in females of childbearing age.
- •Inability or unwillingness to comply with radiation safety procedures or protocol requirements.
结局指标
主要结局
Define the toxicity of 131I-8H9 administered intraperitoneally.
时间窗: weekly
Assessment of toxicity of 131I-8H9 administered intraperitoneally.
次要结局
- Assess response of DSRCT and other solid tumors to 131 I-8H9 administered intraperitoneally(between days 24 and 38)
- Define maximal tolerated dose (MTD) of 131I-8H9 administered intraperitoneally(5 years)
- Assess pharmacokinetics for 131I-8H9 administered intraperitoneally(0 hrs, 60 mins, 2 hrs, 8 hrs, 18hrs, 30 hrs, 42hr, 66hrs, 90 hrs, and 114hrs.)
研究者
研究点 (1)
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