CAMP 013:- Tandem Thiotepa Regimen For Selected Malignant Gliomas:1) Primary Or Recurrent Glioblastoma Multiforme (GBM); and 2) Recurrent Anaplastic Astrocytomas (AA), Oligodendrogliomas (O), Oligoastrocytomas (OA), Ependymomas And Primitive Neuroectodermal Tumors (PNET) That Have Either Progressed After Primary Therapy Or Are Refractory To Standard Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Response rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy with peripheral stem cell or bone marrow transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: This phase II trial is studying how well thiotepa followed by peripheral stem cell or bone marrow transplant works in treating patients with malignant glioma.
详细描述
OBJECTIVES:
- Determine the response rate, disease-free interval, and overall survival of patients with malignant glioma treated with high-dose thiotepa followed by autologous peripheral blood stem cell transplantation.
- Determine the toxicity of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
- Determine whether this drug enters the cerebrospinal fluid of these patients.
OUTLINE: Following a course of induction chemotherapy with cyclophosphamide IV over 4 hours, patients receive filgrastim (G-CSF) daily until the completion of peripheral blood stem cell (PBSC) harvesting. PBSCs are collected over 3-5 days. Patients who do not mobilize sufficient cells undergo bone marrow harvest.
Patients receive high-dose thiotepa IV over 5 hours on day -2. PBSCs or bone marrow are reinfused on day 0. Patients receive sargramostim (GM-CSF) subcutaneously daily beginning on day 0 and continuing until blood counts recover. Treatment repeats every 2-3 weeks for a total of 1-4 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, at every course, then monthly for 6 months, and then every 2 months thereafter.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed malignant glioma
- •Primary or recurrent glioblastoma multiforme (including gliosarcoma) following surgery and radiotherapy or prior conventional chemotherapy (e.g., carmustine or procarbazine, vincristine, and lomustine)
- •Recurrent or refractory anaplastic astrocytoma following any prior therapy (must be chemoresistant)
- •Recurrent or refractory ependymoma or primitive neuroectodermal tumor (PNET) following any prior therapy
- •Recurrent or refractory oligodendroglioma or oligoastrocytoma following any prior therapy (must be chemoresistant)
- •Evaluable disease on gadolinium-enhanced MRI
- •Ineligible for other high priority national or institutional study (e.g., protocol CAMP-004)
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Not specified
- •Creatinine less than 1.5 times normal
- •Cardiovascular:
- •LVEF at least 45% by MUGA
- •DLCO at least 60% of predicted OR
- •Approval by pulmonologist
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •HIV negative
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •See Disease Characteristics
- •No other concurrent chemotherapy
- •Endocrine therapy:
- •No concurrent anticancer hormonal therapy
- •No concurrent steroids as antiemetics
- •Radiotherapy:
- •See Disease Characteristics
- •See Surgery
- •See Disease Characteristics
- •For patients with glioblastoma multiforme, concurrent surgery and/or stereotactic radiosurgery to reduce tumor bulk allowed
- •No concurrent acetaminophen during chemotherapy
排除标准
- 未提供
结局指标
主要结局
Response rate
Disease-free interval
Overall survival
Toxicity
次要结局
- Pharmacokinetics
- Presence of high-dose thiotepa in the cerebrospinal fluid