NCT00980551撤回不适用
A Pilot Study of Intravenous Topotecan and Vincristine in Combination With Subconjunctival Carboplatin for Patients With a History of Bilateral Retinoblastoma and Refractory/Recurrent Intraocular Disease (IND# 104,942)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- To estimate the event-free survival, where an event is defined at the ocular level as the need for non-protocol therapy defined as additional non-protocol chemotherapy, external beam radiation, or enucleation.
研究概览
简要总结
The investigators are testing subtenon carboplatin in combination with vincristine and topotecan given by vein in the hopes of finding a drug combination that may be effective against retinoblastoma that has come back (recurrent) or is resistant to other treatment (refractory).
The goals of this study are:
- To decide if the drug combination is a useful treatment for recurrent or refractory retinoblastoma
- To test the safety of the drug combination and to see what kind of effects (good and bad) can be expected from the drug combination
- To measure visual changes before and after the study therapy
- To use a special MRI scan to measure brain function involved in vision processing, both before and after the study therapy
In this study, the investigators are also testing a new experimental way of giving carboplatin "subtenon carboplatin". The carboplatin will be given directly in the eye through a needle placed under the covering of the eye. This is to try to get more carboplatin to the retinoblastoma inside the eye.
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 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: ≤ 10 years of age
- •Diagnosis: Patients must have a history of bilateral Retinoblastoma AND Recurrent/Refractory Intra-Ocular Retinoblastoma considered not amenable to cure with local therapies alone (photocoagulation with argon laser, cryotherapy, transpupillary thermotherapy, radioactive plaque therapy).
- •Therapeutic Options: Patient's disease status is one for which there are no known options proven to provide a high chance for ocular salvage or cure other than external beam radiation or enucleation.
- •Remaining visual function in target eye (s) is required
- •Life Expectancy of > 8 weeks
- •Lansky ≥ 50
- •Prior Therapy: Patients must have local relapsed/refractory disease after receiving standard upfront therapy involving at least one chemotherapeutic regimen. There is no limit to prior chemotherapeutic regimens permitted. Patients may have received previous intravenous carboplatin, but may not have received prior subtenon carboplatin or intravenous topotecan.
- •Patients must have recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study, as described below:
- •Myelosuppressive chemotherapy: patients must not have received myelosuppressive chemotherapy within 3 weeks of study enrollment
- •Biologic therapies: Patients must not have received biologic anti-cancer agents within one week of study enrollment
- •Radiation therapy: Four weeks must have elapsed since external beam radiation therapy, if given.
- •Adequate Bone Marrow Function Defined as:
- •Peripheral absolute neutrophil count (ANC) ≥ 750/µL
- •Platelet count ≥ 75,000/µL (transfusion independent, defined as not receiving platelet transfusions within a 7-day period prior to enrollment)
- •Hemoglobin ≥ 8.0 gm/dL (may receive RBC transfusions)
- •Adequate Renal Function Defined as:
- •Creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73 m2 OR threshold creatinine values based on age/gender derived from the Schwartz formula for estimating GFR
- •Adequate Liver Function Defined As:
- •Bilirubin (sum of conjugated + unconjugated) ≤ 1.5 x upper limit of normal (ULN) for age
- •SGPT (ALT) ≤ 5 x upper limit of normal (ULN) for age
- •Serum albumin ≥ 2 g/dL
排除标准
- •Extra-ocular retinoblastoma
- •Asynchronous involvement of the contralateral eye, previously untreated
- •Uncontrolled infection at time of protocol entry
- •Concomitant Medications:
- •Growth factors that support platelet or white cell number or function must not have been administered within the past 3 days
- •Patients who are currently receiving investigational drugs, or who have received an investigational drug within the last 7 days, are ineligible
- •Patients who are currently receiving other anti-cancer agents are ineligible
- •Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible
研究组 & 干预措施
Topotecan/Vincristine with subtenon Carboplatin
Experimental
干预措施: subtenon Carboplatin (Drug)
Topotecan/Vincristine with subtenon Carboplatin
Experimental
干预措施: Topotecan Hydrochloride (Drug)
Topotecan/Vincristine with subtenon Carboplatin
Experimental
干预措施: Vincristine (Drug)
Topotecan/Vincristine with subtenon Carboplatin
Experimental
干预措施: Filgrastim (Drug)
结局指标
主要结局
To estimate the event-free survival, where an event is defined at the ocular level as the need for non-protocol therapy defined as additional non-protocol chemotherapy, external beam radiation, or enucleation.
时间窗: at 1 year
To estimate the patterns of response, and response rate of locally refractory retinoblastoma to combination intravenous and peri-ocular chemotherapy.
时间窗: at 1 yr
次要结局
- To describe the toxicities associated with the proposed regimen.(at 1 yr)
- To describe the histologic findings in the eyes ultimately requiring enucleation.(at 1 yr)
- To describe the visual acuity of patients with advanced intraocular retinoblastoma before and after the proposed therapy.(at 1 yr)
- To describe primary visual cortex function in patients with retinoblastoma via functional Magnetic Resonance Imaging (fMRI) technique both before and after the proposed therapy.(at 1 yr)
研究者
研究点 (1)
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