NCT00022724已完成1 期
Phase I/II Trial Of CCI-779 In Patients With Malignant Glioma
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins10 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2001年8月27日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 10
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.
PURPOSE: Phase I/II trial to study the effectiveness of CCI-779 in treating patients who have malignant glioma.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of CCI-779 in patients with malignant glioma.
- Determine the safety profile of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
- Determine the efficacy of this drug, in terms of survival and objective response, in these patients.
OUTLINE: This is a dose-escalation study. Patients in phase II are stratified according to use of enzyme-inducing antiepileptic drugs (EIAEDs) (yes vs no) and disease type (glioblastoma multiforme with stable neuro-imaging after radiotherapy vs recurrent malignant glioma). Patients in phase I must be currently receiving EIAEDs.
- Phase I: Patients receive CCI-779 IV over 30 minutes once weekly. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of CCI-779 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed intracranial malignant glioma
- •Glioblastoma multiforme
- •Anaplastic astrocytoma
- •Anaplastic oligodendroglioma
- •Anaplastic mixed oligoastrocytoma
- •Malignant astrocytoma not otherwise specified
- •Initial diagnosis of low-grade allowed, if subsequently progressed
- •Recurrent disease must have documented progression by MRI or CT scan
- •Progressive disease must have failed prior radiotherapy
- •Recent resection of recurrent or progressive tumor allowed provided all of the following are met:
- •Recovered from surgery
- •CT scan or MRI performed no more than 96 hours postoperatively OR at 4-6 weeks postoperatively
- •Concurrent steroid dosage must be stable
- •Confirmation of true progressive disease (by PET, thallium scan, MR spectroscopy, or surgical documentation) required after prior interstitial brachytherapy or stereotactic radiosurgery
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 60-100%
- •Life expectancy:
- •More than 8 weeks
- •Hematopoietic:
- •WBC at least 3,000/mm3
- •Absolute neutrophil count at least 2,000/mm3
- •Platelet count at least 120,000/mm3
- •Hemoglobin at least 10 g/dL (transfusion allowed)
- •Bilirubin less than 1.5 times upper limit of normal (ULN)
- •SGOT less than 1.5 times ULN
- •Cholesterol less than 350 mg/dL
- •Triglycerides less than 400 mg/dL
- •Creatinine less than 1.5 mg/dL
- •Creatinine clearance at least 60 mL/min
- •No active infection
- •No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- •No significant medical illness that would preclude study
- •No disease that would obscure toxicity or dangerously alter drug metabolism
- •No history of allergic reactions attributed to compounds of similar chemical or biologic composition to CCI-779 or allergy to or inability to receive antihistamines
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 12 weeks after study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 1 week since prior interferon
- •Chemotherapy:
- •At least 2 weeks since prior vincristine
- •At least 3 weeks since prior procarbazine
- •At least 6 weeks since prior nitrosoureas
- •2 prior chemotherapy regimens allowed
- •1 prior adjuvant regimen and 1 prior regimen for recurrent or progressive disease OR
- •2 prior regimens for progressive tumor
- 另有 13 项未显示
排除标准
- 未提供
研究者
研究点 (10)
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