A Multi-institutional Feasibility Study of Intra-arterial Chemotherapy Given in the Ophthalmic Artery of Children With Retinoblastoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 12
- 主要终点
- Number of Patients Experiencing Feasibility Failure
研究概览
简要总结
This pilot clinical trial studies whether unilateral group D retinoblastoma, or retinoblastoma affecting one eye that has spread to the inner jelly like part of the eye, can be treated with a new technique for delivering chemotherapy directly into the blood vessel that supplies the affected eye. This new technique is called intra-arterial injection. Giving melphalan via intra-arterial injection may make it less likely that children will need surgery to remove the eye and may reduce the amount of treatment side effects.
详细描述
PRIMARY OBJECTIVES:
I. To study the feasibility of delivering melphalan directly into the ophthalmic artery in children with newly diagnosed unilateral group D retinoblastoma, who would otherwise be considered for enucleation.
SECONDARY OBJECTIVES:
I. To estimate the ocular salvage rate after treatment with intra-arterial melphalan in children with newly diagnosed unilateral retinoblastoma with group D disease.
II. To evaluate the toxicities and adverse events associated with delivering multiple doses of intra-arterial chemotherapy.
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
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed patients with unilateral group D retinoblastoma
- •Magnetic resonance imaging (MRI) (or computed tomography [CT] if MRI is not available) of the brain must be performed within 14 days prior to study entry
- •Diagnostic examination under anesthesia (EUA) must be performed within 14 days prior to study entry
- •Rapid central review confirmation of group D disease based on RetCam images from diagnostic EUA must be obtained before starting treatment
- •Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2
- •Patients must have a life expectancy of >= 8 weeks
- •Patients must have adequate renal function, defined as:
- •Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or
- •A serum creatinine based on age/gender as follows:
- •1 month to < 6 months: 0.4 mg/dL
- •6 months to < 1 year: 0.5 mg/dL
- •1 to < 2 years: 0.6 mg/dL
- •2 to < 6 years: 0.8 mg/dL
- •6 to < 10 years: 1 mg/dL
- •10 to < 13 years: 1.2 mg/dL
- •13 to < 16 years: 1.5 mg/dL (male); 1.4 mg/dL (female)
- •>= 16 years: 1.7 mg/dL (male); 1.4 mg/dL (female)
- •Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
- •Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x upper limit of normal (ULN) for age
排除标准
- •Patients with bilateral disease
- •Unilateral retinoblastoma with group A, B, C, or E eyes
- •Prior chemotherapy or radiation therapy for this disease (laser and cryotherapy are allowed and are not considered exclusion criteria)
- •Clinical or neuroimaging evidence of extraocular disease or orbital optic nerve involvement
研究组 & 干预措施
Treatment (melphalan)
Patients receive melphalan IA on day 1. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
干预措施: Melphalan (Drug)
结局指标
主要结局
Number of Patients Experiencing Feasibility Failure
时间窗: Up to 4 months
Feasibility failure is defined as a) interventional radiologist is unable to access the ophthalmic artery for the 1st chemotherapy administration for any reason; b) patient develops central retinal artery occlusion after the 1st or 2nd course that does not reopen by the time the next injection is due; or c) the patient cannot receive all three treatments because of Common Terminology Criteria for Adverse Events (CTCAE) complications grade III or IV that are considered possibly, probably or likely related treatment.
次要结局
- Incidence of Grade 3 or Higher CTCAE Adverse Events Associated With Multiple Doses of IA Chemotherapy(Up to 30 days after completion of study treatment)
- Probability of Ocular Salvage(2 years)
- Rate of Metastases of Retinoblastoma(Up to 2 years)
- Vision Acuity, Assessed According to the Amblyopia Treatment Study Visual Acuity Testing Protocol(1 year after therapy)