A Phase I/II Trial of Temodar in Pediatric Patients and Young Adults With High-Risk or Recurrent Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Overall response at 12 months
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of temozolomide when given with peripheral stem cell transplantation and to see how well they work in treating children with newly diagnosed malignant glioma or recurrent CNS tumors or other solid tumors.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of temozolomide in children with newly diagnosed malignant glioma or recurrent CNS or other solid tumors.
- Evaluate the toxicity of this treatment in these patients.
- Determine the activity of this treatment in these patients.
OUTLINE: This is a dose escalation study of temozolomide.
Patients receive filgrastim (G-CSF) subcutaneously (SQ) or IV beginning on day -5 and continuing through at least day 3. Peripheral blood stem cells (PBSC) are collected on days 0, 2, and 4. Patients then receive oral temozolomide daily for 5 consecutive days. PBSC collections are reinfused 1 day after the last dose of temozolomide. Patients also receive G-CSF beginning at the time of transplant and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of temozolomide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicities.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed newly diagnosed malignant glioma or recurrent malignant CNS tumor of any pathology OR
- •Histologically confirmed non-CNS tumor
- •Recurrent soft tissue sarcomas (e.g., rhabdomyosarcoma)
- •Recurrent or resistant neuroblastoma
- •Recurrent Wilm's tumor
- •Recurrent Ewing's sarcoma
- •Recurrent primitive neuroectodermal tumors
- •Recurrent nasopharyngeal carcinoma
- •Recurrent germ cell tumor
- •Expected cure rate less than 10% with standard therapy
- •Measurable and/or active disease
- •History of bone marrow tumor infiltration with or without mass lesions or isolated abnormal CSF cytology as only evidence of recurrent disease allowed if complete response was first achieved with primary conventional therapy
- •PATIENT CHARACTERISTICS:
- •18 and under
- •Performance status:
- •Karnofsky 70-100% OR
- •Lansky 70-100%
- •Life expectancy:
- •Greater than 8 weeks
- •Hematopoietic:
- •Reasonably cellular bone marrow (greater than 15% cellularity on biopsy)
- •Absolute neutrophil count greater than 1,000/mm^3
- •Platelet count greater than 75,000/mm^3
- •Bilirubin less than 2.0 mg/dL
- •SGPT less than 120 U/L
- •Creatinine less than 1.5 mg/dL
- •Cardiovascular:
- •Systolic fraction or ejection fraction at least 80% predicted for age by echocardiogram
- •CVC or DLCO at least 60% predicted for age OR clearance from pulmonologist
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •HIV negative
- •No active infection
- •Able to tolerate vigorous hydration schedule
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No concurrent white blood cell transfusion
- •No other concurrent hematopoietic growth factors
- •Chemotherapy:
- •See Disease Characteristics
- •At least 4 weeks since prior chemotherapy
- •No other concurrent cytotoxic drugs (systemic or intrathecal)
- •Endocrine therapy:
- •Concurrent corticosteroids allowed
- •Radiotherapy:
- •See Disease Characteristics
- •At least 1 week since prior radiotherapy
- •At least 1 week since prior surgery
- 另有 1 项未显示
排除标准
- 未提供
结局指标
主要结局
Overall response at 12 months
Disease-free survival at 12 months
次要结局
- Toxicity by NCI Common Toxicity Criteria v. 3.0 at 12 months
- Engraftment related to autologous marrow or peripheral blood stem cell transplantation at 12 months