NCT00610571已完成1 期
Phase I Trial of Oral Topotecan Plus Temodar in the Treatment of Patients With Malignant Gliomas
Katy Peters1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2004年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- maximum tolerated dose
研究概览
简要总结
Objectives:
- To determine the maximum tolerated dose of oral topotecan when administered with Temodar to patients with malignant glioma
- To characterize any toxicity associated with the combination oral topotecan and Temodar.
- To observe patients for clinical antitumor response when treated with oral topotecan and Temodar.
详细描述
Subjects are patients with glioblastoma (GBM), anaplastic astrocytoma (AA) or grade 3 or greater WHO astrocytic, oligodendroglial or mixed glial tumors, which were initially diagnosed by histologic examination of biopsy/resection. Modified classical "3+3" phase I design used to determine maximum tolerated dose of topotecan in combination with Temodar.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Histology: GBM, AA or grade 3 or greater WHO astrocytic, oligodendroglial or mixed glial tumors which were initially diagnosed by histologic exam of biopsy/resection
- •Age: > or equal to 18 years
- •Performance Status: Karnofsky Performance Status > or equal to 60% at study entry.
- •Renal Function: Serum creatinine < 1.5 mg/dl or creatinine clearance > 60 ml/dL.
- •Hematologic Status: The following baseline studies will be required before entry: total granulocyte count > or equal to 1000/microliter; platelet count > 100,000/microliter
- •Hepatic Function: Serum SGOT & total bilirubin < or equal to 2.5 times ULN.
- •Note: All lab parameters must have been obtained within 1 week of registration
- •Consent: Signed informed consent, approved by IRB, will be obtained prior to initiating treatment
- •Corticosteroids: For patients currently on corticosteroids, patients should be on stable dose for 1 week prior to study entry, if clinically possible.
- •Prior Therapy: Interval of at least 2 weeks between prior surgical resection or prior radiotherapy (XRT) or 1 week from completion of chemotherapy and all toxicities are < or equal to grade 1 & enrollment on this protocol unless there is unequivocal evidence of progressive disease.
- •Patients with Reproductive Potential: Patients must agree to practice effective birth control measures while on study and for 2 months after completing therapy
排除标准
- •Pregnant or breast feeding women or women or men with reproductive potential not practicing adequate contraception. This therapy may be associated with potential toxicity to the fetus or child that exceeds minimum risks necessary to meet health needs of mother
- •Active infection requiring intravenous antibiotics
- •Prior failure with either topotecan or temozolomide
研究组 & 干预措施
Oral Topotecan and Temodar
Experimental
Two separate strata to accrue independently. Stratum 1: Patients taking receiving Dilantin, Tegretol, Trileptal or Phenobarbital. Stratum 2: Patients on anti-convulsants other than Dilantin, Tegretol, Trileptal or Phenobarbital or patients not on any anti-convulsants
干预措施: Oral Topotecan and Temodar (Drug)
结局指标
主要结局
maximum tolerated dose
时间窗: 6 months
次要结局
- Safety & efficacy(6 months)
研究者
Katy Peters
Assistant Professor
Duke University
研究点 (1)
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