NCT00895180已完成2 期
An Open Label, Phase 2 Study Evaluating the Safety and Efficacy of IMC-3G3 or IMC-1121B in Patients With Recurrent Glioblastoma Multiforme
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins11 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2010年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 11
- 主要终点
- Percentage of Participants Who Achieved Progression-Free Survival Rate at 6 Months (PFS-6)
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as ramucirumab and anti-PDGFR alpha monoclonal antibody IMC-3G3 (Olaratumab), 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 ramucirumab or anti-PDGFR alpha monoclonal antibody IMC-3G3 works in treating patients with recurrent glioblastoma multiforme.
详细描述
OBJECTIVES:
Primary
- To assess the progression-free survival rate at 6 months after treatment with ramucirumab or anti-PDGFR alpha monoclonal antibody IMC-3G3 in patients with recurrent glioblastoma multiforme.
Secondary
- To evaluate the acute and late toxicities associated with these regimens.
- To assess the objective tumor response rate.
- To estimate the overall survival of these patients.
- To describe the pharmacokinetic and pharmacodynamic profiles and immunogenicity of these regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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 supratentorial glioblastoma multiforme (GBM)
- •Patients with prior low-grade glioma who progressed after radiotherapy ± chemotherapy and are biopsied and found to have GBM are eligible
- •Progressive or recurrent disease after radiotherapy ± chemotherapy
- •Measurable disease by contrast-enhanced MRI or CT scan
- •PATIENT CHARACTERISTICS:
- •Karnofsky performance status 60-100%
- •Life expectancy ≥ 3 months
- •Absolute neutrophil count ≥ 1,500/millimeter cubed (mm³)
- •Platelet count ≥ 100,000/mm³
- •Hemoglobin ≥ 9 gram/deciliter (g/dL)
- •Creatinine ≤ 1.5 milligram/deciliter (mg/dL) OR creatinine clearance > 60 mL/min
- •Total bilirubin ≤ 1.5 mg/dL
- •Transaminases ≤ 3 times upper limit of normal (ULN)
- •Urine protein ≤ 2+ by dipstick or urinalysis or ≤ 1,000 mg by 24-hour urine collection
- •International Normalized Ratio (INR) ≤ 1.5
- •Partial Thromboplastin Time (PTT) ≤ 5 seconds above ULN
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for ≥ 12 weeks after completion of study treatment
- •Mini Mental State Exam score ≥ 15
- •Able to undergo magnetic resonance imaging (MRI) (i.e., no pacemaker, aneurysm clip, or claustrophobia)
- •No concurrent serious infection or medical illness that would jeopardize the ability of the patient to receive the treatment outlined in this study with reasonable safety including, but not limited to, any of the following:
- •Uncontrolled hypertension
- •Symptomatic congestive heart failure
- •Unstable angina pectoris
- •Cardiac arrhythmia
- •Psychiatric illness/social situation that would limit compliance with study requirements
- •No other malignancy within the past 5 years, except curatively treated carcinoma in situ or basal cell carcinoma of the skin
- •No major bleeding episode within the past 3 months
- •No myocardial infarction, unstable angina pectoris, cerebrovascular accident, or transient ischemic attack within the past 6 months
- •No serious or non-healing wound, ulcer, or bone fracture
- •No uncontrolled or poorly controlled hypertension, despite standard medical management
- •No known allergy to any of the treatment components
- •No known HIV positivity or AIDS-related illness
- •No uncontrolled thrombotic or hemorrhagic disorders
- •No grade 3-4 gastrointestinal bleeding within the past 3 months
- •No gross hemoptysis (≥ ½ teaspoon) within the past 2 months
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Recovered from prior therapy
- •At least 3 months since prior radiotherapy
- •At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)
- •At least 2 weeks since prior FDA-approved, non-cytotoxic agents (e.g., celecoxib, thalidomide)
- •At least 3 weeks since prior investigational, non-cytotoxic agents
- •More than 28 days since prior major surgery, including brain biopsy
- •More than 7 days since prior subcutaneous venous access device placement
- •No prior treatment with other agents that directly inhibit Platelet-Derived Growth Factor Receptor (PDGFR)α/β, Platelet-Derived Growth Factor (PDGF), Vascular Endothelial Growth Factor (VEGF), or Vascular Endothelial Growth Factor Receptor (VEGFR)s
- •No concurrent therapeutic anticoagulation, chronic daily treatment with aspirin (> 325 mg/day), or other known inhibitors of platelet function
- •No concurrent prophylactic hematopoietic growth factors (e.g., erythropoietin, Granulocyte Colony Stimulating Factor (G-CSF), Granulocyte-macrophage Colony Stimulating Factor (GM-CSF), or Interleukin (IL-11) during the first course of treatment
- 另有 3 项未显示
排除标准
- 未提供
研究组 & 干预措施
Group 2
Experimental
Patients receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
干预措施: olaratumab (Biological)
Group 1
Experimental
Patients receive ramucirumab IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
干预措施: ramucirumab (Biological)
结局指标
主要结局
Percentage of Participants Who Achieved Progression-Free Survival Rate at 6 Months (PFS-6)
时间窗: Start of treatment to PD or Death Up To 6 Months
PFS was defined as the start of treatment to the earliest date of tumor progression or death from any cause based on the modified Response Assessment in Neuro-Oncology Group through the American Society of Clinical Oncology (RANO) criteria. Progression is defined by any of the following: ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions; any new lesion; or clinical deterioration. RANO is a standardized response criteria using bi-dimensional measurements of the largest contrast-enhancing area (Macdonald, 1990).
次要结局
- Number of Participants With Treatment Emergent Adverse Events as Assessed by NCI CTCAE v4.0 (National Cancer Institute-Common Terminology Criteria for Adverse Events)(Start of Treatment to End of Study (Up to 13 Months))
- Percentage of Participants With Anti-Olaratumab Antibodies (ADA)(Start of Treatment to 30-day Post Infusion Follow Up (Up to 6 Months))
- Median Overall Survival (OS)(Start of Treatment to Death Up To 27 Months)
- Percentage of Participants With Anti-Ramucirumab Antibodies (ADA)(Start of Treatment to 30-day Post Infusion Follow Up (Up to 6 Months))
- Pharmacokinetics (PK): Concentration Maximum (Cmax) and Concentration Minimum (Cmin) of Ramucirumab(Cycle 7, Day 1: Prior to Infusion,1 hour (hr) Post Infusion)
- Percentage of Participants (Pts) With Complete Response (CR), Partial Response (PR) and Minor Response (MR) (Objective Response Rate [ORR])(Start of Treatment to PD Up To 20 Months)
- Pharmacodynamics (PD) Profiles(Cycle 7, Day 1: Prior to Infusion, 1 hr Post Infusion)
- PK: Cmax and Cmin of Olaratumab(Cycle 3, Day 1: Prior to Infusion, 1 hr Post Infusion)
研究者
研究点 (11)
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