NCT01462695已完成2 期
A Phase II Study of Sunitinib (NSC# 736511) in Recurrent, Refractory or Progressive High Grade Glioma and Ependymoma Tumors in Pediatric and Young Adult Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 96
- 主要终点
- Sustained Objective Response Rate
研究概览
简要总结
This phase II trial studies how well sunitinib malate works in treating younger patients with recurrent, refractory, or progressive malignant glioma or ependymoma. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
详细描述
PRIMARY OBJECTIVES:
I. To estimate the objective response rate (partial response [PR] or complete response [CR] ≥ 8 weeks) to sunitinib in 2 strata (recurrent/progressive/refractory high-grade glioma vs ependymoma) of recurrent or progressive brain tumors in pediatric and young adult patients.
SECONDARY OBJECTIVES:
I. To explore and report descriptively the safety and tolerability of sunitinib in pediatric and young adult brain tumor patients who have not received prior anthracycline or radiotherapy involving the heart.
II. To describe the pharmacokinetic profile of pediatric and young adult patients taking sunitinib malate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be diagnosed with ependymoma or high-grade glioma (World Health Organization [WHO] grade III/IV):
- •Stratum A: recurrent/progressive/refractory malignant glioma (i.e., anaplastic astrocytoma, glioblastoma multiforme [including giant cell and gliosarcoma types], anaplastic oligodendroglioma, anaplastic oligoastrocytoma, or anaplastic ganglioglioma) within the brain with or without spinal cord disease
- •Stratum B: recurrent/progressive/refractory ependymoma (including ependymoma variants) within the brain with or without spinal cord disease
- •Patients with diffuse intrinsic pontine glioma are not eligible
- •A histological diagnosis from either the initial presentation or at the time of recurrence is required
- •Patients must have radiographically documented measurable disease in the brain, defined as at least one lesion that can be accurately measured in at least 2 planes
- •To document the degree of residual tumor, the following must be obtained:
- •All patients must have a brain MRI with and without gadolinium and a spine magnetic resonance imaging (MRI), if clinically indicated,with and without gadolinium, performed within 2 weeks prior to study enrollment
- •Patients with evidence of new central nervous system (CNS) hemorrhage of more than punctate size and/or more than 3 foci of punctate hemorrhage on baseline MRI obtained within 14 days prior to study enrollment are not eligible
- •Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1, or 2 (use Karnofsky for patients > 16 years of age and Lansky for patients ≤ 16 years of age)
- •Neurological deficits in patients must have been relatively stable for a minimum of 1 week prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
- •Peripheral absolute neutrophil count (ANC) ≥ 1,000/μL
- •Platelet count ≥ 75,000/μL (transfusion independent, defined as not receiving platelet transfusions within the 7-day period prior to enrollment)
- •Hemoglobin ≥ 8.0 g/dL (may receive red blood cell [RBC] transfusions)
- •Creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 70 mL/min OR serum creatinine based on age/gender as follows:
- •0.4 mg/dL (1 month to < 6 months of age)
- •0.5 mg/dL (6 months to < 1 year of age)
- •0.6 mg/dL (1 to < 2 years of age)
- •0.8 mg/dL (2 to < 6 years of age)
- •1.0 mg/dL (6 to < 10 years of age)
- •1.2 mg/dL (10 to < 13 years of age)
- •1.5 mg/dL (male) or 1.4 mg/dL (female) (13 to < 16 years of age)
- •1.7 mg/dL (male) or 1.4 mg/dL (female) (≥ 16 years of age)
- •Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •Serum glutamic oxaloacetic transaminase (SGOT/AST) and serum glutamic pyruvic transaminase (SGPT/ALT) ≤ 2.5 times ULN
- •Shortening fraction of ≥ 27% by echocardiogram OR ejection fraction of ≥ 50% by radionuclide angiogram
- •Corrected QT interval < 450 msec (males) or < 470 msec (females)
- •Prothrombin time (PT) / international normalized ratio (INR) ≤ 1.5 times ULN
- •Partial thromboplastin time (PTT) ≤ 1.5 times ULN
- •Patients must not have a history of cardiac disease including, but not limited to:
- •Uncontrolled hypertension within 12 months prior to enrollment; uncontrolled hypertension is defined as follows:
- •Patients aged ≤ 17 years: greater than 95th percentile systolic and diastolic blood pressure based on age and height which is not controlled by one anti-hypertensive medication
- •Patients aged > 17 years: systolic blood pressure ≥ 140 mm Hg and/or diastolic blood pressure ≥ 90 mm Hg which is not controlled by one anti-hypertensive medication
- •Ongoing cardiac dysrhythmias ≥ grade 2 or atrial fibrillation of any grade
- •Unstable angina, symptomatic congestive heart failure, or myocardial infarction
- •Patients with a seizure disorder may be enrolled if on non-enzyme-inducing anticonvulsants and well controlled
- •Commonly used non-enzyme-inducing anticonvulsants include: gabapentin, lamotrigine, levetiracetam, tiagabine, topiramate, valproic acid, and zonisamide
- •Patients must not have had a cerebrovascular accident or transient is chemic attack within 12 months prior to enrollment
- •Patients must not have had a pulmonary embolism or other significant thromboembolic event within 12 months prior to enrollment
- •Patients must not have had grade ≥ 3 hemorrhage within 4 weeks prior to enrollment
- •Patients must not have had any of the following diagnoses within 6 months prior to enrollment: peptic ulcer disease, inflammatory bowel disease, or diverticulitis
- •Patients with a diagnosis of abdomen fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within 6 months prior to enrollment are not eligible
- •Patients who have an uncontrolled infection are not eligible
- •Patients with hypothyroidism that has not been well-controlled by medications for at least 2 weeks prior to study entry are not eligible
- •Patients who have a personal history of genetic and/or congenital cardiac abnormalities are not eligible
- •Patients who have a history of allergic reactions to compounds of similar chemical or biological composition to sunitinib are not eligible
- •Patients who have any other condition that could result in an inability to swallow capsules/sprinkles or absorb oral sunitinib administered through a gastric tube are not eligible
- •Patients with body surface area < 0.55 m^2 or > 2.18 m^2 are not eligible
- •Female patients who are pregnant are not eligible
- •Lactating females are not eligible unless they have agreed not to breastfeed their infants
- 另有 23 项未显示
排除标准
- 未提供
研究组 & 干预措施
Treatment (sunitinib)
Experimental
Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Diagnostic Laboratory Biomarker Analysis (Other)
Treatment (sunitinib)
Experimental
Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Pharmacological Study (Other)
Treatment (sunitinib)
Experimental
Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Sunitinib Malate (Drug)
结局指标
主要结局
Sustained Objective Response Rate
时间窗: Up to 5 years
Sustained objective response was defined as a PR (Partial Response: ≥ 50% decrease in the sum of the products of the 2 perpendicular diameters of all target lesions (up to 5), taking as reference the initial baseline measurements) or CR (Complete Response: disappearance of all target lesions) lasting at least 8 weeks.
次要结局
未报告次要终点
研究者
研究点 (96)
Loading locations...
相似试验
已完成
2 期
Sunitinib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic LymphomaB-cell Chronic Lymphocytic LeukemiaRecurrent Small Lymphocytic LymphomaRefractory Chronic Lymphocytic LeukemiaNCT00398112National Cancer Institute (NCI)18
已完成
2 期
A Study of Sunitinib in Recurrent and/or Metastatic Adenoid Cystic Carcinoma of the Salivary GlandsSalivary Gland CancerAdenoid Cystic CarcinomaNCT00886132University Health Network, Toronto14
已完成
2 期
Sunitinib in Treating Patients With Relapsed or Refractory Diffuse or Mediastinal Large B-Cell LymphomaAdult Diffuse Large Cell LymphomaRecurrent Adult Diffuse Large Cell LymphomaStage IV Adult Diffuse Large Cell LymphomaNCT00392496National Cancer Institute (NCI)19
已完成
2 期
Sunitinib in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the UterusRecurrent Uterine SarcomaUterine LeiomyosarcomaNCT00378911National Cancer Institute (NCI)44
已完成
2 期
Sunitinib in Treating Patients With Recurrent and/or Metastatic Head and Neck CancerMetastatic Squamous Neck Cancer With Occult Primary Squamous Cell CarcinomaRecurrent Metastatic Squamous Neck Cancer With Occult PrimaryRecurrent Squamous Cell Carcinoma of the HypopharynxRecurrent Squamous Cell Carcinoma of the LarynxRecurrent Squamous Cell Carcinoma of the Lip and Oral CavityRecurrent Squamous Cell Carcinoma of the NasopharynxRecurrent Squamous Cell Carcinoma of the OropharynxRecurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityStage IV Squamous Cell Carcinoma of the HypopharynxStage IV Squamous Cell Carcinoma of the LarynxStage IV Squamous Cell Carcinoma of the Lip and Oral CavityStage IV Squamous Cell Carcinoma of the NasopharynxStage IV Squamous Cell Carcinoma of the OropharynxStage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal CavityNCT00387335National Cancer Institute (NCI)22