NCT00005859已完成1 期
Phase I/II Trial of R115777 in Patients With Recurrent Malignant Glioma
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins11 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2000年5月16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
- 136
- 试验地点
- 11
研究概览
简要总结
RATIONALE: Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.
PURPOSE: Phase II trial to study the effectiveness of tipifarnib in treating patients who have recurrent or progressive malignant glioma.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of tipifarnib in patients with recurrent or progressive malignant glioma receiving enzyme-inducing antiepileptic drugs. (Stratum II in the phase I portion of this study closed to accrual effective 07/16/2001.) (Phase I completed effective 10/2/2001.) (Phase II open only to patients requiring resection and who provide surgical tissue samples [effective 3/13/2003].)
- Define the safety and pharmacokinetic profile of this drug in this patient population.
- Assess for evidence of antitumor activity of this drug in these patients.
- Assess for evidence of inhibition of farnesyl protein transferase (FTase) on peripheral blood monocytes as a surrogate endpoint of effective biologic activity of this drug in these patients.
- Determine the efficacy of this drug as measured by 6-month progression-free survival and objective tumor response in these patients.
- Evaluate further the safety profile of this drug in these patients.
- Correlate treatment response with inhibition of FTase in peripheral blood monocytes in patients treated with this drug.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to their pretreatment medications (not receiving enzyme-inducing antiepileptic drugs [EIAEDs] vs receiving EIAEDs with or without steroids).
Patients receive oral tipifarnib twice daily on days 1-21. Courses repeat every 4 weeks in the absence of unacceptable toxicity or disease progression.
- Phase I (completed 10/2/2001): Cohorts of 3-6 patients from stratum II receive escalating doses of tipifarnib 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. (Stratum II in the phase I portion of this study closed to accrual effective 07/16/2001.)
- Phase II (open only to patients requiring resection and who provide surgical tissue samples [effective 3/13/2003]): Once the MTD is determined, additional patients with glioblastoma multiforme from stratum II are accrued to receive treatment with tipifarnib at the recommended phase II dose.
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
- 盲法
- None
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 primary malignant glioma
- •Glioblastoma multiforme
- •Anaplastic astrocytoma*
- •Anaplastic oligodendroglioma*
- •Anaplastic mixed oligodendroglioma*
- •Malignant astrocytoma (not otherwise specified)* NOTE: *Closed to accrual effective 5/28/2002
- •Progressive or recurrent disease confirmed by MRI or CT scan within the past 14 days
- •Stable steroid dose for at least 5-7 days
- •Confirmation of true progressive disease by PET scan, thallium scan, MR spectroscopy, or surgery if prior therapy included interstitial brachytherapy or stereotactic radiosurgery
- •Failed prior radiotherapy
- •Phase I (phase I completed effective 10/2/2001): No more than 2 prior chemotherapy or cytotoxic regimens, including 1 prior adjuvant therapy and 1 prior regimen for progressive or recurrent disease, or 2 prior regimens for progressive disease
- •Phase II (phase II open only to patients requiring resection and who provide surgical tissue samples [effective 3/13/2003]): No more than 2 prior chemotherapy or cytotoxic regimens for relapsed disease following initial therapy (radiotherapy with or without chemotherapy)
- •Prior surgical resection for relapsed disease with no anticancer therapy for up to 12 weeks followed by another surgical resection is considered 1 relapse
- •Patients who received prior therapy for a low-grade glioma with a surgical diagnosis of a high-grade glioma are considered to be in first relapse
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 60-100%
- •Life expectancy:
- •More than 8 weeks
- •Hematopoietic:
- •WBC at least 3,000/mm^3
- •Absolute neutrophil count at least 2,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 10 g/dL (transfusion allowed)
- •Bilirubin no greater than 2.5 times upper limit of normal (ULN)
- •SGOT no greater than 2.5 times ULN
- •Creatinine less than 1.5 mg/dL
- •Cardiovascular:
- •No uncontrolled high blood pressure
- •No unstable angina
- •No symptomatic congestive heart failure
- •No myocardial infarction within the past 6 months
- •No serious uncontrolled cardiac arrhythmia
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No severe nonmalignant systemic diseases or active infections
- •No other severe concurrent disease that would preclude study therapy
- •No allergy to azoles (e.g., ketoconazole, itraconazole, or voriconazole)
- •HIV negative
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 1 week since prior interferon
- •No concurrent anticancer immunotherapy
- •No concurrent routine prophylactic filgrastim (G-CSF) during first course of study
- •No concurrent sargramostim (GM-CSF)
- •Chemotherapy:
- •See Disease Characteristics
- 另有 25 项未显示
排除标准
- 未提供
研究者
研究点 (11)
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