Phase I Study of Intrathecal 131-I-3F8 Monoclonal Antibody in Patients With GD2 Positive Leptomeningeal Neoplasms
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have leptomeningeal metastases.
详细描述
OBJECTIVES:
- Define the clinical toxicities of intrathecal iodine I 131 monoclonal antibody 3F8 (I-3F8) in patients with GD2 positive leptomeningeal neoplasms.
- Determine whether I-3F8 can detect GD2 positive leptomeningeal tumors.
- Measure the cerebrospinal fluid (CSF) levels and serum pharmacokinetics of I-3F8 in these patients.
OUTLINE: This is a dose escalation study.
Patients receive a single injection of intraventricular or intrathecal iodine I 131 monoclonal antibody 3F8. Patients without objective disease progression and no grade 3 or 4 toxicity 6 weeks after the first dose may receive a second injection.
Cohorts of at least 3 patients are entered at escalating doses of I-3F8. If grade 3 or worse toxicity occurs in 1 or more of 3 patients at a given dose level, then 3 additional patients are accrued at that level. If 2 or more of 6 patients at a given dose level experience grade 3 or worse toxicity, then that dose is declared the maximum tolerated dose (MTD).
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed malignancy expressing GD2, including, but not limited to:
- •Medulloblastoma/primitive neuroectodermal tumor of the CNS
- •Malignant glioma
- •Neuroblastoma
- •Retinoblastoma
- •Ependymoma
- •Small cell lung carcinoma
- •Other tumor types must have GD2 expression confirmed by immunohistochemical staining
- •Cerebrospinal fluid or leptomeningeal disease that is refractory to conventional therapy or for which no conventional therapy exists
- •Prior measurable human anti-mouse monoclonal antibody titer allowed
- •PATIENT CHARACTERISTICS:
- •3 and over
- •Performance status:
- •Not specified
- •Life expectancy:
- •At least 2 months
- •Hematopoietic:
- •Absolute neutrophil count greater than 1,000/mm^3
- •Platelet count greater than 50,000/mm^3
- •Bilirubin less than 3 mg/dL
- •Creatinine less than 2 mg/dL
- •Blood urea nitrogen less than 30 mg/dL
- •May have active malignancy outside the central nervous system
- •No obstructive hydrocephalus
- •No CNS grade 3 or 4 toxicity as a consequence of prior treatments
- •No life threatening infection
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Prior monoclonal antibody treatment allowed
- •Chemotherapy:
- •Prior chemotherapy allowed
- •Must have recovered from all hematopoietic and neurologic side effects of prior chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Prior radiotherapy allowed
- •At least 6 weeks since prior cranial or spinal irradiation
- •Not specified
排除标准
- 未提供