A Phase II Safety Study of Bevacizumab in Patients With Multiple Recurrent or Progressive Malignant Gliomas
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Progression-free Survival at 6 Months
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well bevacizumab works in treating patients with recurrent or progressive glioma.
详细描述
OBJECTIVES:
- Determine the safety of single-agent bevacizumab in the treatment of patients with recurrent or progressive malignant glioma.
- Determine the efficacy of bevacizumab, in terms of progression-free survival at 6 months, in these patients.
- Assess changes in tumoral blood flow based on magnetic resonance (MR) perfusion and tissue changes by MR spectroscopy.
OUTLINE: This is a pilot study.
Patients receive bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed malignant glioma, including the following:
- •Glioblastoma multiforme
- •Gliosarcoma
- •Anaplastic astrocytoma or anaplastic glioma
- •Malignant glioma not otherwise specified
- •Evidence of tumor recurrence or progression by MRI or CT scan with contrast
- •CT scan or MRI must be performed ≤ 96 hours post-operatively (≤ 2 weeks prior to study registration) or 4-6 weeks post-operatively to assess residual disease in patients who have undergone recent resection of recurrent or progressive tumor
- •Steroid dosage must have been stable for ≥ 5 days
- •Failed ≥ 1 prior systemic treatment with chemotherapy or biologic agents (excluding polifeprosan 20 with carmustine implant [Gliadel wafers])
- •Failed prior external-beam radiotherapy
- •If received prior interstitial brachytherapy or stereotactic radiosurgery, true progressive disease (rather than radiation necrosis) must be confirmed by positron emission tomography, single-photon emission computer tomography with thallium, magnetic resonance (MR) spectroscopy, MR perfusion, or surgical documentation
- •PATIENT CHARACTERISTICS:
- •Karnofsky performance status 70-100%
- •Life expectancy > 8 weeks
- •WBC > 3,000/mm³
- •Absolute neutrophil count > 1,500/mm³
- •Platelet count > 100,000/mm³
- •Hemoglobin > 10 g/dL (transfusion allowed)
- •SGOT and SGPT < 1.5 times upper limit of normal (ULN)
- •Bilirubin < 1.5 times ULN
- •Creatinine < 1.5 mg/dL
- •Blood pressure ≤ 150/100 mm Hg
- •No unstable angina
- •No New York Heart Association class II-IV congestive heart failure
- •No stroke or myocardial infarction within the past 6 months
- •No clinically significant peripheral vascular disease
- •No evidence of bleeding diathesis or coagulopathy
- •Urine protein:creatinine ratio < 1.0
- •No significant medical illness that would preclude study participation or cannot be adequately controlled with appropriate therapy
- •No other serious medical illness or infection
- •No disease that would obscure toxicity or dangerously alter drug metabolism
- •No significant traumatic injury within the past 28 days
- •No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
- •No serious, nonhealing wound, ulcer, or bone fracture
- •No history of any other cancer (except nonmelanoma skin cancer or carcinoma in situ of the cervix) unless cancer is in complete remission and patient is off all therapy for that cancer for ≥ 3 years
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •More than 4 weeks since prior surgery for recurrent or progressive disease and recovered
- •More than 28 days since prior major surgical procedure or open biopsy
- •At least 4 weeks since prior cytotoxic therapy (6 weeks for nitrosoureas)
- •At least 2 weeks since prior vincristine
- •At least 3 weeks since prior procarbazine hydrochloride
- •At least 1 week since prior noncytotoxic agents (e.g., interferon, tamoxifen, thalidomide, or isotretinoin)
- •Radiosensitizer does not count
- •At least 4 weeks since prior experimental biologic agents (e.g., epidermal growth factor receptor [EGFR] inhibitors)
- •More than 7 days since prior minor surgery, such as fine-needle aspirations or core biopsies
- 另有 3 项未显示
排除标准
- 未提供
研究组 & 干预措施
Avastin
干预措施: bevacizumab (Biological)
结局指标
主要结局
Progression-free Survival at 6 Months
时间窗: After all patients have surpassed the 6 month post-treatment timepoint
The number of patients experiencing progression free survival (PFS) was calculated at the 6-month time point.
Safety of Treatment
时间窗: From treatment initiation, throughout treatment and up to 30 days post-treatment, for up to 1 year.
Safety of treatment will be defined by the number of patients that experience grade 3 and 4 adverse events where causal relationship with bevacizumab cannot be completely ruled out. Adverse events will be graded using Common Terminology Criteria for Adverse Events v3.0 (CTCAE) where: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE
Tumoral Blood Flow Changes
时间窗: Before and after treatment
To assess changes in tumoral blood flow based on MR Perfusion and tissue changes by MR spectroscopy.
次要结局
未报告次要终点
研究者
Jeffrey Raizer
Jeffrey Raizer, MD
Northwestern University