107 Participants Needed

Individualized Therapy for Retinoblastoma

Age: Any Age
Sex: Any
Trial Phase: Phase 3
Sponsor: St. Jude Children's Research Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

Retinoblastoma is a childhood cancer which affects the retina of the eye. The retina is the light sensitive layer of tissue that lines the back of the eyeball; sends visual messages through the optic nerve to the brain. When only one eye is affected, this is known as unilateral retinoblastoma and when both eyes are affected, it is called bilateral retinoblastoma. Treatment for retinoblastoma is individualized for each patient and is based on the form and the stage of the disease (inside the eye or has moved outside). The main goal is always to cure the cancer, and save the life of the child. Treatments are also designed with the hope of saving the vision, while completely destroying the tumor. Therapies may involve surgery, chemotherapy, radiation, and other treatments called focal treatments. Focal treatments may be laser therapy, freezing, or heat treatments meant to shrink and kill the tumor.In this study, researchers want to investigate how different participants respond to different therapies that are individualized specifically for them. Participants will be divided into three main groups, depending on whether the disease is unilateral or bilateral, and the stage of the disease. One of the main objectives of the study is to investigate how advanced tumors in children with bilateral disease respond to a new combination of chemotherapy with topotecan and vincristine, with G-CSF support. In order to improve results, some children with very advanced disease may receive carboplatin chemotherapy given around the eye at the same time that they receive topotecan by vein. Also, because children with retinoblastoma are diagnosed so early in life and the vision may be significantly impaired, this study will investigate how children develop and how the brain adjusts and compensates for the visual deficits. Finally, this study also investigates the biology of retinoblastoma, in order to understand better how this cancer develops.

Who Is on the Research Team?

IQ

Ibrahim Qaddoumi, M.D.

Principal Investigator

St. Jude Children's Research Hospital

Are You a Good Fit for This Trial?

This trial is for children with newly diagnosed retinoblastoma, a type of eye cancer. They must have good liver and kidney function, be expected to live at least 8 weeks, and have a performance status showing they can do some daily activities. Kids who've had surgery or focal treatments on one eye but then get cancer in the other are also eligible. Children with spread of cancer outside the eye or an active infection cannot join.

Inclusion Criteria

I have a new diagnosis of eye cancer and haven't been treated, or I had treatment for cancer in one eye and now the other is affected.
Must have a life expectancy of at least 8 weeks.
I am able to get out of my bed or chair and move around.
See 3 more

Exclusion Criteria

I do not have a serious infection right now.
Patients who have received treatment for this condition before.
My cancer has spread to other parts of my body or affects my eye socket.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive individualized treatment based on the form and stage of retinoblastoma, including chemotherapy, surgery, and focal treatments.

6-12 months
Regular visits for chemotherapy cycles and focal treatments

Follow-up

Participants are monitored for ocular survival and event-free survival, as well as cognitive and developmental assessments.

5 years
Annual visits for assessments and monitoring

Long-term Follow-up

Participants are monitored for changes in visual cortex function and development of pineal cysts.

6 years after last patient enrollment

What Are the Treatments Tested in This Trial?

Interventions

  • Carboplatin
  • Doxorubicin
  • Enucleation
  • Etoposide
  • External Beam Radiation
  • Focal Therapies
  • G-CSF
  • Periocular carboplatin
  • Vincristine
  • Vincristine and Carboplatin
  • Vincristine and Topotecan
  • Vincristine, Carboplatin and Etoposide
Trial Overview The study tests various treatments based on whether one or both eyes are affected and how advanced the disease is. It includes chemotherapy combinations like topotecan and vincristine (with G-CSF support), carboplatin around the eye, plus potential surgeries and focal therapies like laser treatment. The aim is to cure cancer, save vision, understand how kids adapt visually post-treatment, and learn more about retinoblastoma biology.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Stratum CExperimental Treatment5 Interventions
Group II: Stratum BExperimental Treatment8 Interventions
Group III: Stratum AExperimental Treatment5 Interventions

Carboplatin is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Paraplatin for:
🇪🇺
Approved in European Union as Carboplatin for:
🇨🇦
Approved in Canada as Carboplatin for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

St. Jude Children's Research Hospital

Lead Sponsor

Trials
451
Recruited
5,326,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security