Photodynamic Therapy For Childhood Brain Tumors, A Phase I Study
试验速览
- 阶段
- 1 期
- 入组人数
- 24
- 试验地点
- 4
研究概览
简要总结
RATIONALE: Photodynamic therapy uses light and photosensitizing drugs to kill tumor cells and may be an effective treatment for refractory brain tumors.
PURPOSE: This phase I trial is studying the side effects and best dose of photodynamic therapy using porfimer sodium in treating patients with refractory brain tumors, including astrocytoma, ependymoma, and medulloblastoma.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of benzoporphyrin monoacid ring A in patients with refractory brain tumors undergoing cavitary photoillumination photodynamic therapy.
- Determine the effect of this regimen on neurotoxicity, clinical state, imaging changes, and survival of these patients.
OUTLINE: This is a dose-escalation study. Patients are stratified according to tumor location (posterior fossa tumors vs all other brain tumors).
Patients receive benzoporphyrin monoacid ring A (BPD-MA) IV preoperatively. Approximately 3 hours after BPD-MA administration, patients undergo craniotomy with photoillumination of the tumor. Patients with tumors greater than 2 cm in diameter also undergo gross tumor resection.
Cohorts of 3-6 patients receive escalating doses of BPD-MA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose immediately preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Three additional patients are treated at the 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 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of supratentorial or infratentorial brain tumor
- •Localized, non-disseminated
- •Primary tumor or solitary metastasis
- •Recurrent or progressive
- •Unresectable
- •Negative CSF
- •Must have failed standard therapy including radiotherapy
- •Measurable disease as evidenced by CT scan or MRI
- •Single or multiple masses accessible to light administration
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Not specified
- •Life expectancy:
- •At least 2 months
- •Hematopoietic:
- •Absolute neutrophil count at least 1,000/mm3
- •May transfuse platelets
- •PT and PTT normal
- •Not specified
- •Not pregnant
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •At least 6 weeks since prior chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •See Disease Characteristics
- •No prior brachytherapy
- •See Disease Characteristics
- •No other concurrent antitumor therapy
排除标准
- 未提供