CAMP 004A - Phase 2 Study Of Intensive Chemotherapy (BET) For Selected Categories Of Malignant Central Nervous System Tumor
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: This phase II trial is studying how well chemotherapy and peripheral stem cell transplant work in treating patients with central nervous system cancer.
详细描述
OBJECTIVES:
- Determine the response rate in patients with central nervous system malignancies treated with intensive chemotherapy supported by autologous peripheral blood stem cell transplantation following surgical resection and/or radiotherapy.
- Determine the disease-free survival and overall survival of this patient population treated with these regimens.
- Determine the toxicity of this high-dose chemotherapy regimen in these patients.
- Assess the quality of life of these patients following these treatment regimens.
OUTLINE: Patients with anaplastic astrocytoma, esthesioneuroblastoma, germ cell tumor, or primary neuroectodermal tumor undergo initial surgical resection followed by conventional or stereotactic radiotherapy. Patients with germ cell or primary neuroectodermal tumors also receive 4 courses of standard chemotherapy comprising cyclophosphamide, etoposide, and cisplatin prior to high-dose chemotherapy.
All patients undergo peripheral blood stem cell or bone marrow harvest followed by high-dose chemotherapy consolidation. Patients receive thiotepa IV 3 times daily on days -7 to -3, carmustine IV over 1 hour on days -6 to -3, and etoposide IV over 5 hours on days -6 to -3. Patients then undergo transplantation on day 0. Filgrastim (G-CSF) is administered concurrently with stem cell harvesting and transplantation.
Patients with recurrent oligodendroglioma or CNS lymphoma who have not received radiotherapy at diagnosis undergo conventional radiotherapy 6 weeks after completion of high-dose chemotherapy.
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 malignant tumors
- •Anaplastic astrocytoma
- •Oligodendroglioma
- •Germ cell tumor
- •Medulloblastoma
- •Primary neuroectodermal tumor
- •Esthesioneuroblastoma
- •CNS lymphoma (primary or systemic disease)
- •Multifocal intracranial disease allowed
- •No extraneural metastases (except controlled systemic lymphoma)
- •Pretreatment considerations based on tumor type
- •Anaplastic astrocytoma:
- •Recurrent disease
- •Any treatment at diagnosis allowed (carmustine dose limited to 480 mg/m2)
- •Chemotherapy not required at recurrence
- •Oligodendroglioma:
- •Disease response (at least minor) to conventional chemotherapy OR
- •Recurrent disease
- •Esthesioneuroblastoma:
- •Attempted complete surgical resection
- •Disease progression after radiotherapy
- •Response to chemotherapy regimen comprising cyclophosphamide, etoposide, and cisplatin
- •CNS lymphoma:
- •Disease refractory to methotrexate OR
- •Failure after initial treatment with methotrexate OR
- •Considered at high risk for disease relapse despite initial response
- •Radiographic or pathological confirmation of recurrent disease required
- •Not eligible for other high priority national or institutional clinical studies
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •ECOG or Zubrod 0-1
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Not specified
- •Creatinine less than 1.5 times normal
- •Cardiovascular:
- •LVEF at least 45%
- •DLCO at least 60% predicted OR
- •Approval of pulmonologist
- •Not pregnant or nursing
- •HIV negative
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •See Disease Characteristics
- 另有 9 项未显示
排除标准
- 未提供
结局指标
主要结局
Overall survival
Disease-free suvival
Quality of life
Toxicity
Response rate
次要结局
未报告次要终点