NCT01125046已完成2 期
Phase II Trial of Bevacizumab in Patients With Recurrent or Progressive Meningiomas
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 5
- 主要终点
- Progression Free Survival (PFS) of Patients With Recurrent or Progressive Meningiomas Treated With Bevacizumab 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.
PURPOSE: This phase II trial is studying how well bevacizumab works in treating patients with recurrent or progression meningiomas.
详细描述
PRIMARY OBJECTIVES:
I. To determine the efficacy of bevacizumab in patients with recurrent or progressive benign and atypical/malignant meningiomas, despite prior therapy, as measured by six-month progression-free survival.
SECONDARY OBJECTIVES:
I. To describe the response rate and overall-survival in this patient population.
II. To evaluate the safety profile of bevacizumab in patients with recurrent meningiomas.
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 proven recurrent or progressive intracranial meningioma; this includes benign, atypical, or malignant meningioma who may or may not have neurofibromatosis type 1 or 2; pathology can be from initial surgery; OR histologically proven intracranial hemangiopericytoma, hemangioblastoma (with or without metastatic disease), acoustic neuroma, or intracranial schwannoma
- •Unequivocal evidence for tumor progression by MRI (or CT scan if MRI is contraindicated); the scan must be performed within 14 days of registration
- •Steroid dosing- must be on stable dose for at least 5 days prior to baseline imaging (Steroids are not required at the time of baseline imaging)
- •Recent resection for recurrent tumor - patients will be eligible as long as they are greater than four weeks from surgery, have recovered from the effects of surgery, and have residual disease that can be evaluated; to best assess the extent of residual disease post-operatively, a CT/MRI should be done no later than 96 hours in the immediate post-operative period or at least 4 weeks post-operatively; if the 96 hour scan is more than 14 days before registration, it should be repeated
- •Prior radiation therapy - patients may have been treated with standard external beam radiation or radiosurgery in any combination; an interval of >= 8 weeks (56 days) must have elapsed from the completion of radiation therapy to study entry and there must be subsequent evidence of tumor progression
- •Patients with prior stereotactic radiosurgery must have confirmation of true progressive disease rather than radiation necrosis based on PET, MR spectroscopy or surgical documentation of disease
- •Prior therapy: there is no limitation on the number of prior surgeries, radiation therapy, radiosurgery treatments, or chemotherapy agents
- •Prior surgery: must be > 4 weeks from surgery
- •Prior radiation: must be 8 weeks from end of treatment
- •Prior chemotherapy: must be at least 4 weeks from cytotoxic therapy and 2 weeks from biologic therapies
- •All patients must sign an informed consent indicating that they are aware of the investigational nature of the study
- •Patients must sign an authorization for the release of their protected health information
- •Karnofsky performance status >= 60%
- •Absolute neutrophil count (ANC) >= 1,000/mm^3
- •Platelets >= 100,000/mm^3
- •Hemoglobin >= 8gm/dl
- •Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase [SGOT]) =< 2.5 x local laboratory upper limit of normal (ULN)
- •Serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) =< 2.5 x local laboratory upper limit of normal (ULN)
- •Creatinine =< 2.0 mg/dl
- •PT, INR, and PTT =< 1.5 times institutional upper limits of normal
- •Total serum bilirubin =< 1.5
- •Patients with a history of NF may have other stable CNS tumors, such as schwannoma, acoustic neuroma, or ependymoma, but ONLY if these lesions have been stable in size for the preceding 6 months
- •No history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix) unless in complete remission and off all therapy for the disease for a minimum of 5 years
- •Patients may not have a history of prior treatment with inhibitors of the VEGF pathway (eg: VEGF trap, cediranib, vatalanib, sunitinib, sorafenib, etc.)
- •No concurrent treatment on another clinical trial; supportive care trials or non-treatment trials, e.g. QOL, are allowed
- •No history of known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness or other active infection
- •Anticoagulation with therapeutic warfarin (INR <3) and low molecular weight heparin is allowed
- •Pregnancy or breast-feeding (Patients must be surgically sterile, postmenopausal, or agree to use effective contraception during the period of therapy; the definition of effective contraception will be based on the judgment of the principal investigator or a designated associate)
- •Male patients must be surgically sterile or agree to use effective contraception; women of childbearing potential must have a negative B-HCG pregnancy test documented within 14 days prior to registration
- •Patient must be able to comply with the study and follow-up procedures
- •Life expectancy greater than 12 weeks
- •Adequately controlled hypertension (defined as systolic blood pressure =< 150 mmHg and/or diastolic blood pressure =< 100 mmHg)
- •No history of hypertensive crisis or hypertensive encephalopathy
- •Patients must not have New York Heart Association (NYHA) Grade II or greater congestive heart failure
- •No history of myocardial infarction or unstable angina within 12 months prior to Day 1 of treatment
- •No history of stroke or transient ischemic attack
- •Patients must not have significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1 of treatment
- •No history of hemoptysis (>= 1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1 of treatment
- •No evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
- •No history of major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 of treatment or anticipation of need for major surgical procedure during the course of the study
- •No history of minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1 of treatment
- •No history of abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1 of treatment
- •Patients must not have serious non-healing wound, active ulcer, or unhealed bone fracture
- •Urine protein:creatinine (UPC) ratio =< 1.0 at screening OR urine dipstick for proteinuria < 2 (patients discovered to have >= 2 proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate =< 1g of protein in 24 hours to be eligible)
- •No known hypersensitivity to any component of bevacizumab
- •Patients may not have a prior history of bowel perforation
排除标准
- 未提供
研究组 & 干预措施
Arm I
Experimental
Patients receive bevacizumab IV over 30-90 minutes every 2 weeks for 6 months. Patients may then receive bevacizumab IV every 3 weeks for up to 12 months. Treatment continues in the absence of disease progression or unacceptable toxicity.
干预措施: bevacizumab (Biological)
结局指标
主要结局
Progression Free Survival (PFS) of Patients With Recurrent or Progressive Meningiomas Treated With Bevacizumab at 6 Months
时间窗: From the start of treatment and up until 6 months of treatment or follow up
Progression Free Survival (PFS) of patients with recurrent or progressive benign and atypical/malignant Meningiomas (grades I-III), despite prior therapy treated with bevacizumab will be defined from the time of registration to the study until the time of first documentation of progressive disease or death from any cause. Progressive disease will be assessed based on the Macdonald Criteria and is defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, or clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR clear worsening or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer).
次要结局
- Safety Profile of Bevacizumab(Every 2 weeks or 3 weeks while on treatment up to 30 days after the last dose. The maximum duration any one patient was on treatment was approximately 5 years.)
- Number of Patients With Each Response(From start of treatment and approximately every 8 weeks for up to approximately 5 years ( maximum duration any one patient was on treatment))
- Levels of VEGF, VEGRfR2 and HER2 Expression in Tumor Tissue as Compared to Response(At baseline and every 8 weeks until disease progression or death. The maximum duration any one patient was on treatment was approximately 5 years.)
- Number of Patients Alive at 1 Year, 2 Years and 3 Years Post Treatment Initiation (Overall Survival) for Patients With Recurrent or Progressive Meningiomas Treated With Bevacizumab(At 1 year, 2 years, 3 years post treatment initiation)
研究者
研究点 (5)
Loading locations...
相似试验
已完成
2 期
Bevacizumab and Sorafenib in Treating Patients With Recurrent Glioblastoma MultiformeBrain and Central Nervous System TumorsNCT00621686Alliance for Clinical Trials in Oncology54
已完成
2 期
Bevacizumab, Cisplatin, Etoposide, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung CancerLung CancerNCT00387699Eastern Cooperative Oncology Group79
已完成
2 期
Bevacizumab, Temozolomide, and External Beam Radiation Therapy as First-Line Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or GliosarcomaBrain and Central Nervous System TumorsNCT01013285Jonsson Comprehensive Cancer Center70
已完成
2 期
Bevacizumab in Treating Patients With Relapsed or Refractory Multiple MyelomaMultiple Myeloma and Plasma Cell NeoplasmNCT00482495Mayo Clinic42
Unknown
2 期
Bevacizumab, Hormone Therapy, and Radiation Therapy in Treating Patients With Locally Advanced Prostate CancerProstate CancerNCT00348998Virginia Mason Hospital/Medical Center18