NCT00679354已完成2 期
Cilengitide (EMD 121974) (IND# 59073) in Recurrent or Progressive and Refractory Childhood High-Grade Glioma
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
- 20
- 主要终点
- Objective Response to Cilengitide
研究概览
简要总结
This phase II trial studies how well cilengitide works in treating younger patients with recurrent or progressive high-grade glioma that has not responded to standard therapy. Cilengitide may stop the growth of tumor cells by blocking blood flow to the tumor.
详细描述
PRIMARY OBJECTIVES:
I. To determine the objective response rate to cilengitide in younger patients with recurrent or progressive high-grade glioma that is refractory to standard therapy.
SECONDARY OBJECTIVES:
I. To estimate the distribution of time to progression, time to treatment failure, and time to death in these patients.
II. To estimate the rate of toxicity, especially symptomatic intratumoral hemorrhage, in these patients.
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
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed primary central nervous system (CNS) high-grade glioma, including any of the following:
- •Glioblastoma multiforme
- •Anaplastic astrocytoma
- •Anaplastic oligodendroglioma
- •High-grade astrocytoma not otherwise specified (i.e., anaplastic ganglioglioma, anaplastic mixed glioma, or anaplastic mixed glioneuronal tumors)
- •No diffuse pontine gliomas, gliomatosis cerebri, and primary spinal cord high-grade astrocytoma
- •Gliosarcoma
- •Recurrent or progressive disease that is refractory to standard therapy
- •Radiographically documented measurable disease
- •Lesion must be at least twice the thickness of the image from which it is derived (e.g., 10 mm for a 5 mm slice thickness)
- •No diffuse pontine gliomas
- •No evidence of prior CNS bleeding
- •Karnofsky performance status (PS) 50-100% (patients > 16 years of age)
- •Lansky PS 50-100% (patients =< 16 years of age)
- •Life expectancy >= 8 weeks
- •Absolute neutrophil count (ANC) >= 1,000/μL
- •Platelet count >= 100,000/μL (transfusion independent)
- •Hemoglobin >= 8.0 g/dL (red blood cell [RBC] transfusions allowed)
- •Creatinine clearance or radioisotope glomerular filtration rate >= 70mL/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 1.4mg/dL (female) (13 to < 16 years of age)
- •1.7 mg/dL (male) or 1.4mg/dL (female) (>= 16 years of age)
- •Total bilirubin =< 1.5 times upper limit of normal (ULN) for age
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 times ULN for age
- •No evidence of dyspnea at rest
- •No exercise intolerance
- •Pulse oximetry > 94%, if determination is clinically indicated
- •Seizure disorder is allowed provided it is well-controlled with anticonvulsants
- •No uncontrolled infection
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Recovered from all prior therapy
- •No more than two prior treatments for high-grade glioma (i.e., one initial treatment and one treatment for relapse)
- •More than 2 weeks since prior myelosuppressive chemotherapy (>= 6 weeks for nitrosoureas)
- •At least 1 week since prior non-myelosuppressive chemotherapy, immunotherapy, or biologic therapy
- •At least 2 weeks since prior local palliative radiotherapy (i.e., small port) to a symptomatic non-target lesion only
- •At least 3 months since prior craniospinal radiotherapy
- •At least 6 weeks since prior substantial bone marrow radiotherapy
- •At least 6 months since prior allogeneic stem cell transplant (SCT) or rescue
- •Patients who have undergone prior allogeneic SCT and who have graft-versus-host disease (GVHD) must have controlled GVHD that is =< grade 2
- •At least 1 month since prior autologous SCT
- •More than 1 week since prior growth factors (> 3 weeks for pegfilgrastim [Neulasta®])
- •No other concurrent anticancer therapy, including chemotherapy or immunomodulating agents
- •No other concurrent experimental agents or therapies
- 另有 6 项未显示
排除标准
- 未提供
研究组 & 干预措施
Treatment (cilengitide)
Experimental
Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
Treatment (cilengitide)
Experimental
Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: cilengitide (Drug)
Treatment (cilengitide)
Experimental
Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: pharmacological study (Other)
结局指标
主要结局
Objective Response to Cilengitide
时间窗: Up to 16 weeks
Objective response is defined as a complete response or partial response at 4 weeks that is sustained for at least another 4 weeks, or a stable disease at 4 weeks that is sustained for at least 12 weeks while on stable or decreasing dose of corticosteroids, except when corticosteroids are being used to control hydrocephaly unrelated to tumor progression.
次要结局
- Time to Death (TTD)(Time from study enrollment to death from any cause, assessed up to 5 years)
- Pharmacokinetic Parameter of Cilengitide in Plasma: Systemic Clearance (Cl)(At baseline and 1, 3, and 6 hours after the first dose of cilengitide)
- Time to Treatment Failure (TTF)(Time from study enrollment to tumor progression, tumor recurrence, death from any cause, or occurrence of a second malignant neoplasm, assessed up to 5 years)
- Rate of Toxicity, Especially That of Symptomatic Intratumoral Hemorrhage (ITH) Assessed by Common Terminology Criteria for Adverse Events Version 4.0(Up to 5 years)
- Pharmacokinetic Parameter of Cilengitide in Plasma: Elimination Rate Constant (Ke)(At baseline and 1, 3, and 6 hours after the first dose of cilengitide)
- Pharmacogenetic Polymorphism in Drug Transporter Gene ABCB1 and Relate to Cilengitide Disposition as Measured by AUC(At baseline)
- Pharmacogenetic Polymorphism in Drug Transporter Gene ABCB1 and Relate to Cilengitide Disposition as Measured by Systemic Clearance(At Baseline)
- Time to Tumor Progression (TTP)(Time from study enrollment to radiographically determined tumor progression or recurrence, assessed up to 5 years)
- Pharmacogenetic Polymorphism in Drug Transporter Gene ABCG2 and Relate to Cilengitide Disposition as Measured by Systemic Clearance(At baseline)
- Pharmacokinetic Parameter of Cilengitide in Plasma: Volume of Central Compartment (Vc)(At baseline and 1, 3, and 6 hours after the first dose of cilengitide)
- Pharmacokinetic Parameter of Cilengitide in Plasma: Half-life (t1/2)(At baseline and 1, 3, and 6 hours after the first dose of cilengitide)
- Pharmacogenetic Polymorphism in Drug Transporter Gene ABCG2 and Relate to Cilengitide Disposition as Measured by AUC(At baseline)
研究者
研究点 (20)
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