NCT04342572已完成1 期
Intra-arterial Chemotherapy for Retinoblastoma (IAC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Feasibility of intra-arterial chemotherapy as measured by the number of participants who receive 3 intra-arterial injections of melphalan
研究概览
简要总结
Children with retinoblastoma who may benefit from intra-arterial chemotherapy will receive up to 3 doses of melphalan and will be assessed for feasibility, toxicity, and response.
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
- 4 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with retinoblastoma >4 months of age16
- •Patients whose other treatment options would require systemic chemotherapy, radiotherapy, or enucleation
- •Patient or parent/legal guardian must sign a written informed consent
- •One of a, b, or c:
- •Patients who have bilateral COG stage B, C, D, or E retinoblastoma (refer to Appendix A) who have undergone systemic chemotherapy without resolution (meaning either has not had CR or has progressed despite systemic chemotherapy) and would have the following treatment options remaining:
- •enucleation of one eye
- •local radiation
- •Patients with non-germline retinoblastoma with unilateral disease who have COG A, B, C, or D tumors (refer to Appendix A).
- •Other patients may be considered on a case by case basis after discussion with pediatric ophthalmology, hematology/oncology, and interventional neuroradiology.
排除标准
- •Opaque or hazy media which precluded visualization of the fundus.
- •New or recurrent retinoblastoma that can be controlled with other conservative measures such as cryotherapy, thermotherapy, or plaque radiotherapy.
- •Unilateral COG group E retinoblastoma (refer to Appendix A) with very poor visual prognosis as defined by pediatric ophthalmologist.
- •Patients who would benefit from systemic chemotherapy.
- •Patients with clinical or radiological evidence suggestive of retinoblastoma invasion of the optic nerve, choroid, sclera, orbit or metastatic sites.
- •Currently receiving any other investigational agents.
- •A history of allergic reactions attributed to compounds of similar chemical or biologic composition to melphalan or other agents used in the study.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
- •Pregnant and/or breastfeeding. Participants of childbearing potential must have a negative pregnancy test within 14 days of study entry.
- •Patients with HIV are eligible unless their CD4+ T-cell counts are < 350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended.
研究组 & 干预措施
Intra-arterial injections of melphalan
Experimental
-Participants will receive intra-arterial injections of melphalan Q4W for 3 cycles.
干预措施: Melphalan (Drug)
结局指标
主要结局
Feasibility of intra-arterial chemotherapy as measured by the number of participants who receive 3 intra-arterial injections of melphalan
时间窗: Completion of enrollment and treatment of all patients (estimated to be 32 months)
-Feasibility is defined as the ability to receive 3 intra-arterial injections of melphalan per patient.
次要结局
- Visual acuity as measured by Cardiff testing(6 months post-treatment)
- Rate of ocular salvage(2 years post-treatment)
- Rate of procedure-related complications(Through 30 days following completion of treatment (estimated to be 4 months))
- Rate of metastatic disease(Completion of treatment (estimated to be 3 months))
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Intrathecal Chemotherapy for Central Nervous System Metastasis in RetinoblastomaRetinoblastoma, ExtraocularNCT04903678Eye & ENT Hospital of Fudan University18
撤回
2 期
Intra-arterial Chemotherapy for Advanced Intraocular RetinoblastomaEye CancerRetinoblastomaNCT01151748Stanford University
已完成
1 期
Intra-arterial Chemotherapy(Chemosurgery) for RetinoblastomaRetinoblastomaNCT00901238Weill Medical College of Cornell University100
已完成
2 期
Chemotherapy Treatment for Children With Intraocular Germ-Line RetinoblastomaRetinal NeoplasmsRetinoblastomaNCT00179920Ann & Robert H Lurie Children's Hospital of Chicago30
已完成
1 期
Intravitreal Carboplatin for the Treatment of Participants With Recurrent or Refractory Intraocular RetinoblastomaRetinoblastomaNCT02792036St. Jude Children's Research Hospital8