A Phase I/II Trial of CPT-11 With Carboplatin in Patients With Glioblastoma Multiforme Prior to Radiation Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 1
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. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining carboplatin with irinotecan in treating patients who have glioblastoma multiforme.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose (MTD) of carboplatin and irinotecan in patients with glioblastoma multiforme. (Phase I closed to accrual as of 6/24/02)
- Determine the toxic effects of this regimen in these patients.
- Determine the objective response in patients treated with the established MTD of this regimen.
- Determine time to tumor progression and survival of patients treated with this regimen.
OUTLINE: This is a dose-escalation study. Patients in the phase II portion of the study are stratified according to age (under 60 vs 60 and over), ECOG performance status (0-1 vs 2), and extent of resection (total vs subtotal). (Phase I closed to accrual as of 6/24/02)
Within 4 weeks of surgery, patients receive carboplatin IV over 30 minutes followed by irinotecan IV over 90 minutes on day 1. Treatment repeats every 4 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of carboplatin and irinotecan 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. Once the MTD is determined, additional patients are accrued to receive carboplatin and irinotecan at the recommended phase II dose. (Phase I closed to accrual as of 6/24/02)
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 confirmed glioblastoma multiforme
- •Measurable disease
- •No CNS metastases or carcinomatous meningitis
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •ECOG 0-2 OR
- •Karnofsky 70-100%
- •Life expectancy:
- •At least 12 weeks
- •Hematopoietic:
- •Granulocyte count greater than 1,500/mm^3
- •Platelet count greater than 100,000/mm^3
- •Hemoglobin at least 9.0 g/dL
- •Bilirubin no greater than 1.5 mg/dL
- •SGOT no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver involvement)
- •No known Gilbert's syndrome
- •Creatinine no greater than 1.5 mg/dL
- •Cardiovascular:
- •No myocardial infarction within the past 6 months
- •No congestive heart failure requiring therapy
- •HIV negative
- •No active or uncontrolled infection
- •No psychiatric disorder that would preclude study
- •No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- •No uncontrolled diabetes mellitus (i.e., random blood sugar of 200 mg or more)
- •No other severe disease that would preclude study
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior immunotherapy or biologic therapy
- •No concurrent sargramostim (GM-CSF)
- •No concurrent filgrastim (G-CSF) with course 1
- •No concurrent immunotherapy
- •Chemotherapy:
- •No prior chemotherapy
- •No other concurrent chemotherapy
- •Endocrine therapy:
- •Must have maintained a stable or decreasing dose of corticosteroids for 2 weeks prior to study
- •Concurrent corticosteroids for cerebral edema allowed
- •No concurrent anticancer hormonal therapy
- •Radiotherapy:
- •No prior radiotherapy
- •No concurrent radiotherapy
- •At least 2 weeks since prior surgery
- •No other concurrent investigational agent or participation on any other clinical study
- •No concurrent immunosuppressive drugs
- 另有 3 项未显示
排除标准
- 未提供