RecruitingPhase 2NCT05504291

A Study to Give Treatment Inside the Eye to Treat Retinoblastoma

Intravitreal Melphalan for Intraocular Retinoblastoma


Sponsor

Children's Oncology Group

Enrollment

26 participants

Start Date

Nov 4, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Max Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Biospecimen Collection, a drug called Carboplatin, and others for people with bilateral retinoblastoma, childhood intraocular retinoblastoma, and other related conditions. The study is currently recruiting participants at 20 locations. People eligible for this study include up to age 18 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo aqueous humor, tissue, and blood sample collection

DRUGCarboplatin

Given IV

DRUGEtoposide

Given IV

PROCEDUREExamination Under Anesthesia

Undergo imaging of the eye during EUA

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

DRUGMelphalan

Given I-VITRE

PROCEDUREUltrasound Biomicroscopy

Undergo UBM during EUA

DRUGVincristine

Given IV


Locations(20)

Children's Hospital of Alabama

Birmingham, Alabama, United States

Children's Hospital Los Angeles

Los Angeles, California, United States

Lucile Packard Children's Hospital Stanford University

Palo Alto, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Children's Healthcare of Atlanta - Arthur M Blank Hospital

Atlanta, Georgia, United States

C S Mott Children's Hospital

Ann Arbor, Michigan, United States

Washington University School of Medicine

St Louis, Missouri, United States

Duke University Medical Center

Durham, North Carolina, United States

Children's Hospital Medical Center of Akron

Akron, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Saint Jude Children's Research Hospital

Memphis, Tennessee, United States

Dell Children's Medical Center of Central Texas

Austin, Texas, United States

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, United States

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, United States

M D Anderson Cancer Center

Houston, Texas, United States

Primary Children's Hospital

Salt Lake City, Utah, United States

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States

Royal Children's Hospital

Parkville, Victoria, Australia

Perth Children's Hospital

Perth, Western Australia, Australia

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec, Canada

View Full Details on ClinicalTrials.gov

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NCT05504291


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