Retinoblastoma Phase II Expanded Access Clinical Trial (NCT06679634)

🧪 Interventions in This Study

• Chemoplaque also referred to as Episcleral Topotecan (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Age: Participants must be \< 8 years of age.
2. 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 Study Period, if required.
3. Must have demonstrated intraocular calcium in the tumor-containing eye by ophthalmic ultrasound or by neuroimaging as part of standard retinoblastoma diagnosis.
4. 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.
5. Performance Level: Lansky ≥ 50 (\<16 years of age); Karnofsky performance scale of ≥50 (≥16 years of age).
6. Organ Function Requirements:
7. Adequate Bone Marrow Function defined as:
8. Peripheral absolute neutrophil count (ANC) ≥ 1000/mm3
9. Platelet count ≥ 100,000/mm3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 Days prior to enrollment)
10. Hemoglobin ≥ 8.0 g/dL at baseline (may receive RBC transfusions)
11. Adequate Renal Function defined as:
12. Creatinine clearance or radioisotope GFR ≥70ml/min/1.73 m2 or

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (2 Sites)

• NewYork Presbyterian Morgan Stanley Children's Hospital — New York, New York
• Children's Wisconsin — Milwaukee, Wisconsin

📞 Contact the Study Coordinator

Phone: (212) 305-0011

Email: bpm2133@cumc.columbia.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Retinoblastoma

• Studying Health Outcomes After Treatment in Patients With Retinoblastoma — Chicago, Illinois
• Protocol for the Study and Treatment of Participants With Intraocular Retinoblastoma — Memphis, Tennessee
• Retinoblastoma Patient Clinical Database and Tissue Repository — Phoenix, Arizona
• Retinoblastoma Survivor Study: Assessment of General Health and Quality of Life — New York, New York

Explore by condition: All Retinoblastoma clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.