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Eye-Directed chemotherapy aims to save sight in children with retinoblastoma

NCT ID NCT01783535

Disease control Sponsor: St. Jude Children's Research Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether giving chemotherapy directly into the eye (subconjunctival carboplatin) along with systemic topotecan can shrink advanced retinoblastoma tumors in children with disease in both eyes. The goal is to preserve the eye and vision, avoiding removal. Participants also receive standard treatments like cryotherapy, laser therapy, or radiation as needed. The study includes children with newly diagnosed retinoblastoma and those whose disease spreads to the other eye after prior treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
vincristine, topotecan, filgrastim, PEG-filgrastim, carboplatin
What this could lead to
If successful, this approach could help more children with advanced retinoblastoma keep their eye and vision, reducing the need for surgical removal.
What could go wrong
This is an early-phase study, so the treatment may not work for everyone. Chemotherapy carries risks like infection, low blood counts, and potential side effects from drugs given directly into the eye.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

174 people

The number who actually took part.

Started

Jun 2013

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Newly diagnosed, untreated intraocular retinoblastoma. Participants previously diagnosed with unilateral retinoblastoma treated surgically, with focal therapy or needing chemotherapy who develop asynchronous involvement of the contralateral eye, or patients with unilateral retinoblastoma treated only with enucleation or focal therapy who develop asynchronous involvement of the contralateral eye, will be eligible for study. * ECOG Performance Score must be ≤ 2 within two weeks prior to registration. * Participants must have an adequate liver function, as defined by bilirubin ≤ to 3X upper limit of normal (ULN), and SGOT and SGPT ≤ to 3X ULN. * Participants must have adequate renal function as defined by serum creatinine ≤ to 3X ULN for age. * Legal guardians must sign an informed consent indicating that they are aware of this study, the possible benefits, and toxic side effects. Legal guardians will be given a signed copy of the consent form. Exclusion Criteria: * Previously treated participants. * Presence of metastatic disease or gross (residual) orbital involvement * Participants must not have an invasive infection at time of protocol entry. * Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.

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Conditions

The condition(s) this trial relates to.

intraocular retinoblastoma retinoblastoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Retinoblastoma

Contacts and locations

Locations

  • St. Jude Children's Research Hospital

    Memphis, Tennessee, 38105, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.