NCT00052624Unknown1 期
A Phase I Multicenter Trial Of Intratumoral/Interstitial Therapy With HN66000, NC66000 (TransMID) In Patients Between 5 and 18 Years Of Age With Progressive Or Recurrent Glioblastoma Multiforme Or Anaplastic Astrocytoma
Xenova Biomedix4 个研究点 分布在 1 个国家开始时间: 2002年7月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 试验地点
- 4
研究概览
简要总结
RATIONALE: Immunotoxins can locate tumor cells and kill them without harming normal cells. Immunotoxin therapy may be an effective treatment for glioblastoma multiforme and anaplastic astrocytoma.
PURPOSE: Phase I trial to study the effectiveness of immunotoxin therapy in treating children who have progressive or recurrent glioblastoma multiforme or anaplastic astrocytoma
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of intratumoral transferrin-CRM107 in pediatric patients with progressive or recurrent glioblastoma multiforme or anaplastic astrocytoma.
- Determine the safety of this drug in these patients.
- Determine the efficacy of this drug in these patients.
- Compare the efficacy of this drug in patients with different histological types of tumor, degrees of transferrin receptor expression, and serum antidiphtheria antibody titer levels.
OUTLINE: This is a dose-escalation, open-label, multicenter study. Patients are assigned to 1 of 2 treatment groups by age (5-9 vs 10-18).
All patients undergo stereotactic radiosurgery for tumor biopsy and placement of 2 intratumoral silastic infusion catheters pre-loaded with transferrin-CRM107 (Tf-CRM107).
- Group 1 (ages 5-9): Patients receive intratumoral Tf-CRM107 over 3-7 days via catheter. Treatment repeats after 6-10 weeks in the absence of unacceptable toxicity. Three cohorts of 3-6 patients receive escalating doses of Tf-CRM107 until the maximum tolerated dose (MTD) is determined.
- Group 2 (ages 10-18): Patients receive intratumoral Tf-CRM107 as in group 1. Two cohorts of 3-6 patients receive escalating doses of Tf-CRM107 until the MTD is determined.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed glioblastoma multiforme or anaplastic astrocytoma with the following tumor characteristics:
- •Unilateral and supratentorial
- •Diameter no greater than 3.5 cm by contrast-enhanced MRI
- •No more than 1 satellite tumor
- •Recurrent or progressive disease
- •Progressive disease defined as at least 25% increase in tumor volume by serial MRI or CT scans and/or at least 15% increase in the largest cross-sectional area of tumor as defined by the area of contrast agent enhancement
- •Must have received prior conventional treatment comprising both of the following:
- •Surgery (biopsy or debulking)
- •Radiation therapy
- •No evidence of mass effect on CT scan or MRI with more than a 5 mm midline shift and/or nausea, vomiting, reduced level of consciousness, or clinically significant papilledema
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Karnofsky 60-100% OR
- •Lansky Play 50-100%
- •Life expectancy
- •At least 3 months
- •Hematopoietic
- •Platelet count at least 100,000/mm^3
- •Absolute neutrophil count at least 1,000/mm^3
- •Bilirubin no greater than 2.0 mg/dL
- •AST and ALT no greater than 2.5 times the upper limit of normal (ULN)
- •PT or aPTT no greater than 1.5 times ULN
- •Not specified
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for at least 2 months after study
- •No acute viral, bacterial, or fungal infection requiring therapy
- •Topical treatment for oral candidiasis allowed
- •No other concurrent medical condition that would preclude anesthesia
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No prior transferrin-CRM107
- •Chemotherapy
- •More than 1 month since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- •More than 3 months since prior biodegradable polymer wafers
- •No concurrent chemotherapy
- •Endocrine therapy
- •Must be on stable dose of steroids for 7 days prior to infusion
- •Radiotherapy
- •See Disease Characteristics
- •More than 3 months since prior radiotherapy
- •More than 3 months since prior stereotactic radiosurgery
- •More than 6 weeks since prior craniospinal irradiation
- •No prior brachytherapy
- •No concurrent radiotherapy
- •See Disease Characteristics
- •More than 1 month since prior surgery including tumor surgery or debulking
- •No other concurrent surgery
- •More than 30 days since prior investigational agents
- 另有 2 项未显示
排除标准
- 未提供
研究者
研究点 (4)
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