Status:
COMPLETED
Neoadjuvant Carboplatin and Vincristine and Standard Local Ophthalmic Therapy in Treating Patients With Intraocular Retinoblastoma
Lead Sponsor:
Children's Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Intraocular Retinoblastoma
Eligibility:
All Genders
Up to 5 years
Phase:
PHASE3
Brief Summary
This phase III trial is studying how well giving carboplatin and vincristine together with standard local ophthalmic therapy works in treating children with intraocular retinoblastoma. Drugs used in c...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the 2-year event-free survival of patients with Group B intraocular retinoblastoma treated with neoadjuvant chemoreduction comprising carboplatin and vincristine and ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Newly diagnosed Group B intraocular retinoblastoma meeting 1 of the following criteria:
- Group B tumor(s) in 1 eye
- Group B tumor(s) in both eyes
- Group A tumor in 1 eye and Group B tumor(s) in the other eye
- Group E tumor in 1 eye that has been enucleated and Group B tumor(s) in the remaining eye at the time of enucleation of the Group E tumor
- Defined by the International Classification System for Intraocular Retinoblastoma as follows:
- Group A: Small tumors (≤ 3 mm in greatest dimension) confined to the retina, away from foveola and disc meeting the following criteria:
- More than 3 mm from fovea
- More than 1.5 mm from optic disk
- Group B: Tumors more than 3 mm meeting the following criteria:
- Confined to the retina in any location not in Group A
- Tumor associated subretinal fluid \< 3 mm from the tumor margin with no subretinal seeding
- Group E: Must have ≥ 1 of the following present:
- Tumor touching the lens
- Tumor anterior to anterior vitreous face involving ciliary body or anterior segment
- Diffuse infiltrating retinoblastoma
- Neovascular glaucoma
- Opaque media from hemorrhage
- Tumor necrosis with aseptic orbital cellulites
- Phthisis bulbi
- Confirmation of diagnosis by CT scan or MRI of the brain and orbits AND an ophthalmologic evaluation under anesthesia within the past 3 weeks
- No choroidal and/or optic nerve invasion past the lamina cribosa
- No evidence of extraocular retinoblastoma clinically or by head and orbital MRI and/or CT scan
- No tumor present on histological exam at the cut end of the optic nerve for any Group E eye enucleated before study entry
- Performance status - ECOG 0-2
- Bilirubin ≤ 1.5 times upper limit of normal (ULN) for age
- AST or ALT \< 2.5 times ULN for age
- Creatinine clearance (based on Schwartz formula) or radioisotope glomerular filtration rate ≥ 70mL/min/1.73 m\^2
- No prior chemotherapy
- No other concurrent chemotherapy
- No prior radiotherapy
- No other concurrent radiotherapy, including intensity-modulated stereotactic, or proton beam radiotherapy
- Prior enucleation of one eye allowed provided the remaining eye is Group B
- No concurrent enucleation
- No prior local ophthalmic therapy for retinoblastoma
- No other prior therapy for retinoblastoma
- No local therapy during chemotherapy course 1
Exclusion
Key Trial Info
Start Date :
December 26 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2017
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00079417
Start Date
December 26 2005
End Date
March 31 2017
Last Update
March 13 2023
Active Locations (10)
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1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
2
Lurie Children's Hospital-Chicago
Chicago, Illinois, United States, 60611
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
4
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States, 48201