Retinoblastoma Phase II Expanded Access Clinical Trial
ConditionRetinoblastoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeUp to 8
SponsorTargeted Therapy Technologies, LLC
About this trial
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.
Eligibility criteria
Qualifiers
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).
Must have demonstrated intraocular calcium in the tumor-containing eye by ophthalmic ultrasound or by neuroimaging as part of standard retinoblastoma diagnosis.
Study eye must have vision potential, at least light perception vision in the tumor-bearing eye either with pupil response testing or demonstration of avoidance behavior to light presentation in the affected eye, and no clinical features suggestive of high risk of extraocular extension.
Disqualifiers
tumor involving the optic nerve rim
clinical or EUA evidence of extraocular extension
evidence of metastatic retinoblastoma
existing neuroimaging showing suspicion of, or definitive, optic nerve invasion, trilateral retinoblastoma or extra-ocular extension.
Trial design
Treatments tested in this trial
- Chemoplaque also referred to as Episcleral Topotecan
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Targeted Therapy Technologies, LLC
Lead sponsor
Morgan Stanley Children's Hospital
Collaborator
Source ClinicalTrials.gov