Retinoblastoma Phase II Expanded Access Clinical Trial
Targeted Therapy Technologies, LLC
Summary
In this research study investigators want to learn more about treatment of advanced or recurrent retinoblastoma. For children with retinoblastoma that have an advanced stage of presentation in one eye or if they have failed all conventional treatment, eye removal is considered. This study will investigate the utility of a chemoplaque(s) to salvage eyes involved with retinoblastoma. The goal of the study is to further determine/assess the safety and efficacy and optimal chemotherapy dose for retinoblastoma.
Description
The chemoplaque will be placed during the first exam under anesthesia (EUA) and this involves a surgery wherein the reservoir that will release the chemotherapy medication will be placed under the conjunctiva (surface lining of the eye) and will be applied with tissue adhesive to the sclera (coating of the eye). The chemoplaque will remain on the eye until day 56 when the chemoplaque will be removed. Eye exam under anesthesia (EUAs) will be performed on Day 0, Day 28, Day 56 (prior to chemoplaque removal), and Day 84 (final visit). Blood will be drawn periodically for testing the blood paramet…
Eligibility
- Age range
- Up to 8 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age: Participants must be \< 8 years of age. * Diagnosis and Treatment. Participants must have: Group D or earlier-stage intraocular retinoblastoma in which enucleation is a recommended therapy, OR Active residual or recurrent intraocular retinoblastoma in at least one eye following completion of first- line therapy (focal therapy for IIRC Group A eyes, or systemic or intra-arterial chemotherapy). If both eyes require treatment, there will receive independent and individual treatment. Non-study eye will be treated by standard of care, with only focal therapy during the…
Interventions
- DrugChemoplaque also referred to as Episcleral Topotecan
Sustained Release Episcleral Topotecan
Locations (2)
- NewYork Presbyterian Morgan Stanley Children's HospitalNew York, New York
- Children's WisconsinMilwaukee, Wisconsin