PHASE I STUDY OF ANTI-TENASCIN MONOCLONAL ANTIBODY 131I 81C6 VIA SURGICALLY CREATED CYSTIC RESECTION CAVITY IN THE TREATMENT OF PATIENTS WITH PRIMARY OR METASTATIC MALIGNANT BRAIN TUMORS
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase I/II trial to study the effectiveness of radiolabeled monoclonal antibody therapy in treating patients who have primary or metastatic brain cancer.
详细描述
OBJECTIVES:
- Determine the toxic effects of intracranial iodine I 131 labeled anti-tenascin monoclonal antibody 81C6 in patients with primary or metastatic anaplastic gliomas.
- Determine the objective therapeutic response of these patients treated with this regimen.
OUTLINE: This is a dose escalation study of iodine I 131 labeled anti-tenascin monoclonal antibody 81C6 (MOAB 81C6). Patients are stratified by prior external beam radiotherapy (yes vs no).
Patients receive iodine I 131 labeled MOAB 81C6 intraventricularly followed by unlabeled MOAB 81C6 intraventricularly.
Cohorts of 3-6 patients receive escalating doses of iodine I 131 labeled MOAB 81C6 until the maximum tolerated dose is determined. The MTD is defined as the highest dose preceding that at which 3 of 6 patients experience dose-limiting toxicity.
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 proven primary or metastatic malignant supratentorial anaplastic glioma
- •Newly diagnosed or recurrent
- •No diffusely infiltrating or multifocal tumor
- •No tumor with subependymal spread
- •Resection of glioma and placement of an intralesional catheter into the surgical cavity required before study
- •Measurable lesion on enhanced CT scan or MRI
- •No measurable enhancing lesion greater than 1.0 cm beyond cavity margin
- •Neoplastic cell reactivity with tenascin demonstrated by immunohistology with either a polyclonal rabbit antibody or a monoclonal murine antibody
- •PATIENT CHARACTERISTICS:
- •3 and over
- •Performance status:
- •Karnofsky 50-100%
- •Hematopoietic:
- •Absolute neutrophil count greater than 1,000/mm^3
- •Platelet count greater than 100,000/mm^3
- •Bilirubin less than 1.5 mg/dL
- •AST less than 1.5 times normal
- •Alkaline phosphatase less than 1.5 times normal
- •Creatinine less than 1.2 mg/dL
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •At least 6 weeks since prior chemotherapy unless unequivocal evidence of tumor progression
- •Endocrine therapy:
- •Corticosteroids allowed if at lowest possible dose and dose stable for at least 10 days prior to entry
- •Radiotherapy:
- •At least 3 months since prior radiotherapy to site of measurable disease unless unequivocal evidence of tumor progression
- •See Disease Characteristics
排除标准
- 未提供