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A Study to Give Treatment Inside the Eye to Treat Retinoblastoma
NCT05504291 · View on ClinicalTrials.gov ↗
Study Summary
This phase II trial tests the safety and side effects of adding melphalan (by injecting it into the eye) to standard chemotherapy in early treatment of patients with retinoblastoma (RB). RB is a type of cancer that forms in the tissues of the retina (the light-sensitive layers of nerve tissue at the back of the eye). It may be hereditary or nonhereditary (sporadic). RB is considered harder to treat (higher risk) when there are vitreous seeds present. Vitreous seeds are RB tumors in the jelly-like fluid of the eye (called the vitreous humor). The term, risk, refers to the chance of the cancer not responding to treatment or coming back after treatment. Melphalan is in a class of medications called alkylating agents. It may kill cancer cells by damaging their deoxyribonucleic acid (DNA) and stopping them from dividing. Other chemotherapy drugs given during this trial include carboplatin, vincristine, and etoposide. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Adding melphalan to standard chemotherapy early in treatment may improve the ability to treat vitreous seeds and may be better than standard chemotherapy alone in treating retinoblastoma.
Conditions Studied
Interventions
- DRUG Carboplatin
- PROCEDURE Biospecimen Collection
- PROCEDURE Magnetic Resonance Imaging
- DRUG Etoposide
- PROCEDURE Examination Under Anesthesia
Study Locations (20)
Texas
- Dell Children's Medical Center of Central Texas — Austin
- UT Southwestern/Simmons Cancer Center-Dallas — Dallas
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center — Houston
- M D Anderson Cancer Center — Houston
California
- Children's Hospital Los Angeles — Los Angeles
- Lucile Packard Children's Hospital Stanford University — Palo Alto
Ohio
- Children's Hospital Medical Center of Akron — Akron
- Cleveland Clinic Foundation — Cleveland
Alabama
- Children's Hospital of Alabama — Birmingham
Colorado
- Children's Hospital Colorado — Aurora
Georgia
- Children's Healthcare of Atlanta - Arthur M Blank Hospital — Atlanta
Michigan
- C S Mott Children's Hospital — Ann Arbor
Missouri
- Washington University School of Medicine — St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2022-11-04 |
| Est. Completion | 2028-03-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05504291
The ClinicalTrials.gov registry entry for NCT05504291 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Oncology Group, which has 318 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Unilateral Retinoblastoma appearing as the primary indexed condition, and to 5 interventions — of which Carboplatin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05504291 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Texas, California, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05504291 about?
NCT05504291 is a clinical study titled "A Study to Give Treatment Inside the Eye to Treat Retinoblastoma". This phase II trial tests the safety and side effects of adding melphalan (by injecting it into the eye) to standard chemotherapy in early treatment of patients with retinoblastoma (RB). RB is a type of cancer that forms in the tissues of the retina (the light-sensitive layers of nerve tissue at the...
What is the current status of trial NCT05504291?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2022-11-04. Estimated completion is 2028-03-31.
What conditions does trial NCT05504291 study?
This clinical trial studies the following conditions: Unilateral Retinoblastoma, Bilateral Retinoblastoma, Childhood Intraocular Retinoblastoma, Group D Retinoblastoma, Stage I Retinoblastoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05504291?
The interventions under investigation include: Carboplatin (DRUG), Biospecimen Collection (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Etoposide (DRUG), Examination Under Anesthesia (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05504291?
This trial is sponsored by Children's Oncology Group, which has 318 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05504291 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Georgia, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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