Phase II Trial of STI571 (NSC 716051) in Patients With Recurrent Meningioma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 7
- 主要终点
- 6 Months - Progression-free Survival According to Response Evaluation Using Macdonald Criteria
研究概览
简要总结
Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have recurrent meningioma. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth
详细描述
PRIMARY OBJECTIVE:
I. Determine the efficacy of imatinib mesylate, in terms of 6-month progression-free survival, of patients with recurrent meningioma.
SECONDARY OBJECTIVES I. Determine the response rate and overall survival of patients treated with this drug.
II. Evaluate the safety profile of this drug in these patients. III. Determine the pharmacokinetics of this drug in these patients. IV. Develop exploratory data concerning surrogate markers of of angiogenic activity in vivo using functional neuro-imaging studies and in vitro assays of serum angiogenic peptides of this drug in these patients.
V. Develop exploratory data concerning evidence of platelet-derived growth factor (PDGF) inhibition in tumor specimens taken from patients undergoing surgery VI. Develop exploratory data correlating molecular abnormalities in the tumor with response in patients treated with this drug.
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
- •Histologically confirmed meningioma
- •Benign, malignant, or atypical disease
- •Neurofibromatosis (NF) type 1 or 2 allowed
- •Hemangiopericytoma allowed
- •Unequivocal evidence of tumor recurrence or progression by MRI or CT scan (on steroid dosage that is stable for at least 5 days)
- •Evaluable residual disease by MRI or CT scan if previously treated with surgical resection for recurrent or progressive disease
- •Newly diagnosed recurrent disease that requires surgical debulking allowed
- •Prior standard external-beam radiotherapy, interstitial brachytherapy, or gamma-knife radiosurgery allowed provided disease has progressed since completion of therapy
- •Patients who have had prior brachytherapy or stereotactic radiosurgery must have confirmation of true progressive disease rather than radiation necrosis based upon positron-emission tomography or thallium scanning, magnetic resonance spectroscopy, or surgical documentation
- •Patients with a history of NF may have other stable Central Nervous System (CNS) tumors (e.g., schwannoma, acoustic neuroma, or ependymoma) provided those lesions have been stable in size for the past 6 months
- •Performance status - Karnofsky 60-100%
- •More than 8 weeks
- •Absolute neutrophil count at least 2,000/mm^3
- •Platelet count at least 120,000/mm^3
- •Hemoglobin at least 10 g/dL (transfusions allowed)
- •No bleeding disorders
- •Bilirubin less than 2 times upper limit of normal (ULN)
- •Serum glutamic oxaloacetic transaminase (SGOT) less than 2 times ULN
- •Prothrombin Time (PT), Partial thromboplastin time (PTT), and International normalized Ratio (INR) no greater than 1.5 times ULN
- •Creatinine less than 1.5 mg/dL
- •Creatinine clearance at least 60 mL/min
- •No deep venous or arterial thrombosis within the past 6 weeks
- •No pulmonary embolism within the past 6 weeks
- •No serious active infection
- •No prior intracranial hemorrhage
- •No concurrent disease that would obscure toxicity or dangerously alter drug metabolism
- •No other malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix unless the patient is in complete remission and off all therapy for that disease for at least 3 years
- •No other significant medical illness that would preclude study participation
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective barrier contraception during and for 3 months after study participation
- •At least 1 week since prior interferon or thalidomide
- •No concurrent immunotherapy
- •Concurrent epoetin alfa allowed
- •At least 4 weeks since prior cytotoxic chemotherapy
- •At least 2 weeks since prior vincristine
- •At least 6 weeks since prior nitrosoureas
- •At least 3 weeks since prior hydroxyurea or procarbazine
- •No concurrent chemotherapy
- •At least 1 week since prior tamoxifen
- •No concurrent hormonal therapy
- •At least 4 weeks since prior radiotherapy
- •No concurrent radiotherapy
- •Recovered from prior surgery
- •Recovered from all prior therapy
- •At least 1 week since prior noncytotoxic therapy (e.g., isotretinoin) except radiosensitizers
- •At least 2 weeks since prior drugs that affect hepatic metabolism
- •At least 4 weeks since prior investigational agents
- •No concurrent warfarin (heparin or low-molecular weight heparin allowed)
- •No other concurrent investigational agents
- 另有 2 项未显示
排除标准
- 未提供
研究组 & 干预措施
Treatment (imatinib mesylate)
Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study/ laboratory biomarker analysis
干预措施: pharmacological study (Other)
Treatment (imatinib mesylate)
Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study/ laboratory biomarker analysis
干预措施: imatinib mesylate (Drug)
Treatment (imatinib mesylate)
Patients receive oral imatinib mesylate once or twice daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Other: pharmacological study/ laboratory biomarker analysis
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
6 Months - Progression-free Survival According to Response Evaluation Using Macdonald Criteria
时间窗: At 6 months
The Macdonald criteria, roughly similarly to other systems, divides response into 4 types of response based on imaging (magnetic resonance imaging \[MRI\]) and clinical features 1: complete response; 2: partial response; 3:stable disease; 4:progression Complete response imaging features: disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks; no new lesions clinical features; no corticosteroids; clinically stable or improved Partial response imaging features: 50% or more decrease of all measurable enhancing lesions sustained for at least 4 weeks: no new lesions clinical features: stable or reduced corticosteroids; clinically stable or improved Stable disease imaging features: does not qualify for complete response, partial response or progression clinical features: clinically stable Progression imaging features: 25% of more increase in enhancing lesions; any new lesions clinical features: clinical deterioration
次要结局
- Determine Survival for Patients Treated With Imatinib Mesylate(3 years)
- Toxicity as Assessed by the Cancer Therapy Evaluation Program Common Toxicity Criteria (CTC) Version 2.0(Up to 5 years after completion of study treatment)
- Progression-free Survival According to Response Evaluation Using Macdonald Criteria(3 years)
- Concentration (Steady State) of Imatinib During Cycle One (Pharmacokinetics)(pre dosing on day 8 and 24 hour dosing day 8 of Pre-dosing Day 9)
- Tumor Response as Assessed by MRI Using Macdonald Criteria(Up to 5 years)