A Study of Intra-Ophthalmic Artery Topotecan Infusion for the Treatment of Retinoblastoma (IARB1)
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|ClinicalTrials.gov Identifier: NCT01466855|
Recruitment Status : Terminated (Competing studies)
First Posted : November 8, 2011
Last Update Posted : March 1, 2017
This study will test if giving topotecan directly into the blood vessel of the eye will improve the treatment of retinoblastoma. This method is referred to as "selective intra-ophthalmic artery chemotherapy" (SIOAC).
The goals of this study are:
- To find out if topotecan is an effective treatment for retinoblastoma when delivered directly to the ophthalmic artery (SIOAC delivery)
- To find out what kind of effects (good and bad) can be expected when topotecan is given by SIOAC
- To assess visual pathway function before and after the study therapy
- To learn more about the pharmacology (how your body handles the drug) of topotecan when delivered directly to the ophthalmic artery
|Condition or disease||Intervention/treatment||Phase|
|Retinoblastoma||Drug: Intra-Ophthalmic Artery Topotecan Infusion||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Intra-Ophthalmic Artery Topotecan Infusion for the Treatment of Retinoblastoma|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||October 2015|
U.S. FDA Resources
Experimental: Treatment of Retinoblastoma
Study of Intra-Ophthalmic Artery Topotecan infusion for the Treatment of Retinoblastoma.
Drug: Intra-Ophthalmic Artery Topotecan Infusion
Topotecan via intra-ophthalmic artery delivery infused over 30 minutes on Day 1 of every 21-day cycle.
- 1-year event-free survival (event defined as the need for external beam radiation or enucleation) [ Time Frame: 1 year ]
- Response rate of retinoblastoma to topotecan when administered directly into the ophthalmic artery. [ Time Frame: Up to 18 weeks ]EUA and retCAM imaging will be used to assess response rate.
- Local (ocular) toxicities associated with the proposed regimen. Toxicities assessed using clinical examinations (EUA and Teller cards and Allan figures or Snellen visual acuity charts or other measures as appropriate for child's age.) [ Time Frame: Up to 12 months ]
- For non-verbal infants we will employ Teller cards or Reacts to Light (if vision is too poor for Teller cards)
- For pre-school age verbal toddlers/children we will employ LEA Symbols or HOTV, and possibly Allen figures
- For older children capable of reading an alphabet we will employ Snellen visual acuity charts. Standard methods to assess color vision will also be employed when feasible.
- Patterns of response of retinoblastoma to topotecan when administered directly into the ophthalmic artery. [ Time Frame: Up to 18 weeks ]Physical examination of the tumors will be recorded at baseline and at every tumor assessment visit. Tumors will be classified as having Type I, II, III, IV, V or O response based on characteristic features identified during physical examination.
- Visual pathway function [ Time Frame: Up to 12 months ]Evaluation of visual pathway function will be measured using visual acuity, electroretinogram, visual evoked potential, and functional magnetic resonance imaging.
- Pharmacokinetics (Cmax and AUC) of topotecan when administered directly into the ophthalmic artery. [ Time Frame: Samples taken 15 and 60 minutes after topotecan administration on Day 1 of Cycle 1 (optional for patients) ]
- Histologic findings in the eyes ultimately requiring enucleation. [ Time Frame: At time of enucleation, only if indicated ]Any eye requiring enucleation will be assessed for the presence or absence of 'high risk' features defined as scleral or massive choroidal invasion of viable tumor, anterior chamber involvement, invasion of the optic nerve posterior to the lamina cribrosa, ciliary body or iris invasion.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01466855
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|Principal Investigator:||James Geller, MD||Children's Hospital Medical Center, Cincinnati|