NCT00004129Unknown1 期
Phase I/II Study of Interstitial Colloidal 32P for the Treatment of Recurrent Malignant Central Nervous System Tumors and Primary Central Nervous System Tumors With Poor Prognostic Factors
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 12
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Radioactive drugs such as phosphorus 32 may be able to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of phosphorus 32 in treating patients with glioblastoma multiforme.
详细描述
OBJECTIVES:
- Determine the dosimetry toxicity of interstitial colloidal phosphorus P32 (C P32) in patients with recurrent or poor prognosis grade 4 astrocytoma.
- Determine the maximum tolerated dose of C P32 administered directly into the tumor of these patients.
- Determine the maximum tolerated fractionated dose of interstitial C P32 in these patients.
- Determine the therapeutic response rate to the acceptable single and fractionated doses of C P32 in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive interstitial colloidal phosphorus P32 (C P32) on day 0. Courses repeat every 4-6 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 patients receive escalating doses of C P32 until the maximum tolerated dose (MTD) is determined. The MTD is defined the dose at which 2 of 3 patients experience dose-limiting toxicity.
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 proven grade 4 astrocytoma (glioblastoma)
- •Failed external beam radiotherapy and/or surgery OR
- •Poor prognosis disease
- •No clinical evidence of metastatic disease within the CNS other than the primary tumor site
- •Stereotactic biopsy or gross total excision with residual tumor
- •Lesion 3 to 5 cm in size
- •No spinal cord tumor(s)
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 70-100%
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC at least 3,000/mm3
- •Neutrophil count at least 1,900/mm3
- •Platelet count at least 100,000/mm3
- •Hemoglobin at least 9 g/dL (transfusion allowed)
- •Not specified
- •Creatinine no greater than 1.5 mg/dL
- •BUN less than 25 mg/dL
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •Not specified
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •See Disease Characteristics
- •See Disease Characteristics
排除标准
- 未提供
研究者
研究点 (1)
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