OncoMatch/Clinical Trials/NCT06679634
Retinoblastoma Phase II Expanded Access Clinical Trial
Is NCT06679634 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Chemoplaque also referred to as Episcleral Topotecan for retinoblastoma.
Treatment: Chemoplaque also referred to as Episcleral Topotecan — 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.
Check if I qualifyExtracted eligibility criteria
Disease stage
Required: Stage GROUP D, EARLIER-STAGE (IIRC)
Group D or earlier-stage intraocular retinoblastoma
Prior therapy
Cannot have received: chemotherapy
Participants who have received chemotherapy, other focal retinoblastoma therapy or any other investigational agent within 3 weeks of Episcleral Topotecan placement are not eligible.
Cannot have received: focal retinoblastoma therapy
Participants who have received chemotherapy, other focal retinoblastoma therapy or any other investigational agent within 3 weeks of Episcleral Topotecan placement are not eligible.
Cannot have received: investigational agent
Participants who have received chemotherapy, other focal retinoblastoma therapy or any other investigational agent within 3 weeks of Episcleral Topotecan placement are not eligible.
Lab requirements
Blood counts
Peripheral absolute neutrophil count (ANC) ≥ 1000/mm3; Platelet count ≥ 100,000/mm3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 Days prior to enrollment); Hemoglobin ≥ 8.0 g/dL at baseline (may receive RBC transfusions).
Kidney function
Creatinine clearance or radioisotope GFR ≥70ml/min/1.73 m2 or a serum creatinine based on age/gender as specified.
Liver function
Bilirubin (sum of conjugated + unconjugated) ≤ 1.5 x ULN for age; SGPT (ALT) ≤ 110 U/L (ULN for SGPT is 45 U/L); Serum albumin ≥ 2 g/dL.
Organ Function Requirements: Adequate Bone Marrow Function, Renal Function, Liver Function as specified.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- NewYork Presbyterian Morgan Stanley Children's Hospital · New York, New York
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