Home/Get Matched/NCT05504291
Phase 2Recruiting
View on ClinicalTrials.gov

Testing Biospecimen Collection with Carboplatin for bilateral retinoblastoma

Official title: A Study to Give Treatment Inside the Eye to Treat Retinoblastoma

Intravitreal Melphalan for Intraocular Retinoblastoma

Condition: Bilateral RetinoblastomaSponsor: Children's Oncology GroupTarget enrollment: 26
  • Phase 2
  • 1 group
  • One site, in Montreal
  • Recruiting
Centre Hospitalier Universitaire Sainte-Justine, Montreal, Quebec

Interventions (8)

  • Medical procedure

    Biospecimen Collection

    Undergo aqueous humor, tissue, and blood sample collection

  • Medication

    Carboplatin

    Given IV

  • Medication

    Etoposide

    Given IV

Canadian Sites (1)

1 of 1 recruiting

  • Centre Hospitalier Universitaire Sainte-Justine

    Montreal, Quebec

    Recruiting

Eligibility Criteria

See who this study is looking for35 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +Patient must have newly diagnosed intraocular (localized) retinoblastoma and meet one of the following criteria:
  • +Patient must be \< 18 years of age at enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →
  • +Unilateral Group D retinoblastoma with vitreous seeding; OR
  • +Bilateral retinoblastoma with worst eye Group D, with vitreous seeding present and the contralateral eye is Group A-C; OR
  • +Bilateral Group D retinoblastoma with at least one eye with vitreous seeding; OR
  • +Bilateral retinoblastoma with one Group D eye with vitreous seeding and one Group E eye where the Group E eye has been enucleated prior to any therapy. Note exclusionExclusion criteriaThe things that would prevent someone from taking part.Read more → for high-risk features
  • +Bilateral retinoblastoma with one Group D eye with vitreous seeding and one Group E eye where the Group E eye has not been enucleated prior to any therapy at the discretion of the treating physician. Note exclusion for patients with evidence of metastatic or extra orbital spread
  • +Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients \> 16 years of age and Lansky for patients =\<16 years of age
  • +Peripheral absolute neutrophil count (ANC) \>= 750/uL (must be performed within 7 days prior to enrollment unless otherwise indicated)
  • +Platelet count \>= 75,000/uL (transfusion independent) (must be performed within 7 days prior to enrollment)
  • +A serum creatinine based on age/sex as follows (must be performed within 7 days prior to enrollment; must be repeated prior to the start of protocolProtocolThe detailed plan a study must follow.Read more → therapy if \> 7 days have elapsed from their most recent prior assessment):
  • +1 month to \< 6 months = 0.4 (male and female)
  • +6 months to \< 1 year = 0.5 (male and female)
  • +1 to \< 2 years = 0.6 (male and female)
  • +2 to \< 6 years = 0.8 (male and female)
  • +6 to \< 10 years = 1.0 (male and female)
  • +10 to \< 13 years = 1.2 (male and female)
  • +13 to \< 16 years = 1.5 (male) and 1.4 (female)
  • +\>= 16 years = 1.7 (male) and 1.4 (female) OR - a 24-hour urine Creatinine clearance \>= 70 mL/min/1.73 m\^2 OR - a glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2. GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard)
  • +Note: Estimated GFR (eGFR) from serum creatinine, cystatin C or other estimates are not acceptable for determining eligibilityEligibility criteriaThe full list of requirements for taking part in a study.Read more →
  • +For patients \< 1 month of age, serum creatinine levels must be \< 1.5 x the treating institution's creatinine upper limit of normal (ULN) for patients \< 1 month of age or the creatinine clearance or radioisotope GFR must be \>= 70 mL/min/1.73 m\^2
  • +The threshold creatinine values were derived from the Schwartz formula for estimating GFR utilizing child length and stature data published by the Center for Disease ControlControl groupThe group a new treatment is measured against.Read more → (CDC)
  • +Total bilirubin =\< 1.5 x upper limit of normal (ULN) for age (must be performed within 7 days prior to enrollment; must be repeated prior to the start of protocol therapy if \> 7 days have elapsed from their most recent prior assessment)
  • +Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 135 U/L (must be performed within 7 days prior to enrollment; must be repeated prior to the start of protocol therapy if \> 7 days have elapsed from their most recent prior assessment)
  • +Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L

Exclusion

  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
  • Patients with evidence of metastatic or extra-orbital spread
  • Patients must not have an invasive infection at time of protocolProtocolThe detailed plan a study must follow.Read more → entry
  • Note: A study eye is defined as being Group D with vitreous seeding. Patients may have had enucleation of one eye as long as the remaining eye is Group D with vitreous seeds
  • Patients with bilateral disease who undergo enucleation of a Group E eye prior to initiation of therapy and show evidence of high-risk histopathology features in the enucleated eye. High-risk histopathology includes choroid involvement \>= 3 mm, post lamina optic nerve involvement, full thickness scleral invasion or optic nerve invasion to the cut end
  • All patients and/or their parents or legal guardians must sign a written informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
  • Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential
  • Lactating females who plan to breastfeed their infants
  • Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation
  • Patients must not have had any prior anti-cancer therapy other than cryotherapy and/or laser therapy (green or infrared) to the study eye(s) and non-study eye, including systemic chemotherapy, intra-arterial chemotherapy, radioactive plaque, brachytherapy, or radiation therapy.
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is testing a treatment for a condition.

Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

Everyone in this study receives Melphalan, together with one or more of: Biospecimen Collection, Carboplatin, Etoposide, Examination Under Anesthesia, Magnetic Resonance Imaging, Ultrasound Biomicroscopy and Vincristine.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

There is only one group in this study, so there is no assignment to different treatments.

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists a maximum age of 18 years.

The study is open to people of any sex.

The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.maximumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 26 people.

The study is currently expected to finish around March 2028.

The main measurement is taken over: Up to cycle 6 (1 cycle = 28 days).

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

Feasibility success rate of intravitreal melphalan injection in combination with systemic chemotherapy — measured over Up to cycle 6 (1 cycle = 28 days).

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT05504291 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About Biospecimen CollectionProcedure

Undergo aqueous humor, tissue, and blood sample collection

From the trial registry — its own words, unedited.

What a procedure is here: A surgery, technique or clinical procedure being studied.

Read the full explanation → · in clinical review

About CarboplatinDrug

Given IV

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About EtoposideDrug

Given IV

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About Examination Under AnesthesiaProcedure

Undergo imaging of the eye during EUA

From the trial registry — its own words, unedited.

What a procedure is here: A surgery, technique or clinical procedure being studied.

Read the full explanation → · in clinical review

About Magnetic Resonance ImagingProcedure

Undergo MRI

From the trial registry — its own words, unedited.

What a procedure is here: A surgery, technique or clinical procedure being studied.

Read the full explanation → · in clinical review

About MelphalanDrug

Given I-VITRE

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About Ultrasound BiomicroscopyProcedure

Undergo UBM during EUA

From the trial registry — its own words, unedited.

What a procedure is here: A surgery, technique or clinical procedure being studied.

Read the full explanation → · in clinical review

About VincristineDrug

Given IV

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.

There is only one group in this study, so there is no assignment to different treatments.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

It is open to people of any sex.

It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: Up to cycle 6 (1 cycle = 28 days).

The study as a whole is currently expected to finish around 2028-03-31.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 26 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists 2 locations, including: Montreal, Quebec, Canada; Ann Arbor, Michigan, United States.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

About This Trial

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.

Other Sites (1)

C S Mott Children's Hospital

Ann Arbor, Michigan, United States

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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.