Phase I Study of At-Labeled Anti-Tenascin Human/Mouse Chimeric Monoclonal Antibody 81C6 (ch81C6) Via Surgically Created Cystic Resection Cavity in the Treatment of Patients With Primary or Metastatic 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 deliver radioactive tumor-killing substances to them without harming normal cells. This may be effective treatment for primary or metastatic brain tumors.
PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy in treating patients with primary or metastatic brain tumors.
详细描述
OBJECTIVES:
- Determine the toxicity of monoclonal antibody (MAb) Astatine At 211 Antitenascin Human/Mouse Chimeric 81C6 (At 211 MAb 81C6) therapy delivered via the intracranial resection cavity in patients with recurrent primary or metastatic malignant brain tumors.
- Identify objective therapeutic responses of these patients to this treatment.
OUTLINE: This is a dose escalation study.
Patients undergo surgical resection of their tumor at which time an indwelling intracranial resection cavity catheter is surgically placed. Patients receive one dose of astatine At 211 antitenascin monoclonal antibody 81C6 (At 211 MAb 81C6) via the intralesional catheter.
Cohorts of 3-6 patients are treated at escalating doses of At 211 MAb 81C6. The maximum tolerated dose is the highest dose at which no more than 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed newly diagnosed or recurrent supratentorial primary or metastatic malignant brain tumor
- •Measurable disease by MRI or CT scan
- •Candidate for surgical resection
- •Extension of tumor no more than 1.0 cm beyond the margin of the surgical cavity
- •Demonstrated reactivity of tumor cells with tenascin by immunohistology with either a polyclonal rabbit antibody or the monoclonal mouse antibody
- •No infratentorial tumors, diffusely infiltrating tumors, tumors with subependymal spread, or multifocal tumors
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 50-100%
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute neutrophil count greater than 1000/mm^3
- •Platelet count greater than 100,000/mm^3
- •Bilirubin less than 1.5 mg/dL
- •Alkaline phosphatase less than 1.5 times normal
- •SGOT less than 1.5 times normal
- •Creatinine less than 1.2 mg/dL
- •Not pregnant or nursing
- •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 progression
- •Endocrine therapy:
- •Concurrent corticosteroids allowed, but must be on stable dose for at least 1 week
- •Radiotherapy:
- •At least 3 months since prior radiotherapy to site of measurable disease in the CNS
- •See Disease Characteristics
排除标准
- 未提供