Treatment of Children With Newly Diagnosed Diffuse Pontine Gliomas Using Conventional Radiotherapy and High Dose Tamoxifen
试验速览
- 阶段
- 2 期
- 发起方
- 试验地点
- 43
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Tamoxifen may kill tumor cells by blocking the enzymes necessary for cell growth. Combining radiation therapy with tamoxifen may be effective in treating newly diagnosed brain stem glioma.
PURPOSE: Phase II trial to study the effectiveness of combining radiation therapy and tamoxifen in treating children who have newly diagnosed brain stem glioma.
详细描述
OBJECTIVES:
- Determine whether high-dose tamoxifen with radiotherapy increases the median survival and overall survival of children with newly diagnosed brain stem gliomas.
- Determine the time to neurologic or radiographic progression in patients treated with this regimen.
- Determine the acute and chronic toxicity of high-dose tamoxifen in these patients.
OUTLINE: This is a multicenter study.
Patients undergo radiotherapy once daily 5 days a week for 6 weeks. Within 2 weeks after the initiation of radiotherapy, patients receive oral high-dose tamoxifen once daily. Tamoxifen continues in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: Approximately 60 patients will be accrued for this study within 4 years.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- — 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Newly diagnosed tumor of the brain stem (diffuse intrinsic lesion centered on the pons)
- •Radiological and clinical diagnostic criteria allowed (biopsy not required)
- •The following astrocytic tumors are allowed if histologically confirmed:
- •Diffuse astrocytoma (all subtypes)
- •Anaplastic astrocytoma
- •Glioblastoma
- •Pilocytic astrocytoma (grade I)
- •Less than 6 months since diagnosis
- •At least 1 of the following signs of brain stem tumor:
- •Cranial nerve deficit
- •Long tract signs
- •No focal lesions of the brain stem (either clearly marginated or cystic), cervicomedullary tumors, tumors predominately exophytic, or pontine tumors diagnosed as pilocytic on biopsy
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Not specified
- •Not specified
- •Not pregnant or nursing
- •No frequent vomiting or other medical condition that would preclude oral medication intake
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •No prior chemotherapy for brain stem glioma
- •Endocrine therapy:
- •Concurrent steroids allowed
- •Radiotherapy:
- •No prior radiotherapy for brain stem glioma
- •Not specified
- •Concurrent anticonvulsants allowed
排除标准
- 未提供