Status:
COMPLETED
Study of Treatment for Patients With Cancer of the Eye -Retinoblastoma
Lead Sponsor:
St. Jude Children's Research Hospital
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Retinoblastoma
Retinal Neoplasm
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
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 ...
Detailed Description
This study will determine the following: PRIMARY OBJECTIVE: * To estimate the ocular survival and event-free survival of bilateral disease patients with advanced intraocular retinoblastoma in either...
Eligibility Criteria
Inclusion
- Must have newly diagnosed intraocular retinoblastoma, previously untreated. Patients previously diagnosed with unilateral retinoblastoma treated surgically (or with focal therapies), who develop asynchronous involvement of the contralateral eye, will be eligible for study.
- Must have a life expectancy of at least 8 weeks.
- Must have Performance Status (ECOG) of 0-2.
- Patients must have an adequate liver function, as defined by bilirubin less than or equal to 3 x normal, and SGOT and SGPT less than or equal to 3x normal.
- Patients must have adequate renal function as defined by serum creatinine less than or equal to 3x normal for age.
- Legal guardians must sign an informed consent indicating that they are aware of this study, its possible benefits, and toxic side effects. Legal guardians will be given a copy of the consent form.
Exclusion
- Previously treated patients
- Presence of metastatic disease or orbital involvement
- Patients must not have an invasive infection at time of protocol entry.
Key Trial Info
Start Date :
April 7 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 12 2024
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT00186888
Start Date
April 7 2005
End Date
November 12 2024
Last Update
September 4 2025
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105