Systemic Chemotherapy and Subtenon Carboplatin, and Local Ophthalmic Therapy in Children With Intraocular Retinoblastoma
Completed · Phase 3
Conditions studied: Intraocular Retinoblastoma
In brief
Phase III trial to determine the effectiveness of combining systemic chemotherapy and subtenon carboplatin with ophthalmic therapy in treating children who have intraocular retinoblastoma. Drugs used in chemotherapy, such as vincristine, carboplatin, and etoposide, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether systemic chemotherapy and subtenon (under the conjunctiva of the eye) carboplatin combined with ophthalmic therapy is effective in treating intraocular (within the eyeball) retinoblastoma.
Key facts
- Study ID
- NCT00072384
- Run by
- Children's Oncology Group
- People needed
- 30
- Starts
- 2007-04-16
- Expected to finish
- 2021-06-30
- Last updated by the study team
- 2021-07-30
Who can join
Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of bilateral retinoblastoma with at least 1 eye group C or D intraocular retinoblastoma by ophthalmologic examination, defined by the International Classification System for Intraocular Retinoblastoma as the following:
- Group C: Discrete localized disease with minimal subretinal and/or vitreous seeding
- Subretinal fluid, without prior or concurrent seeding, involving ≤ one quarter of the retina
- Local fine vitreous seeding may be present close to discrete tumor
- Local subretinal seeding < 3 mm from tumor
- Group D: Diffuse disease with significant vitreous and/or subretinal seeding
- Tumor(s) may be massive or diffuse
- Subretinal fluid, without prior or concurrent seeding, involving up to total retinal detachment
- Diffuse or massive vitreous disease may include "greasy" seeds or avascular tumor masses
- Diffuse subretinal seeding may include subretinal plaques or tumor nodules
- Prior enucleation of 1 eye allowed provided the remaining eye is group C or D
- No tumor present on histologic examination at the cut end of the optic nerve on any eye enucleated prior to study entry
- Evidence of choroidal and/or optic nerve invasion past the lumina cribrosa is allowed
- No extraocular retinoblastoma clinically or by MRI of brain and orbits with and without gadolinium or CT scan with and without contrast of brain and orbits
- No evidence of systemic metastases by bone marrow, lumbar puncture, bone scan, and/or any other additional test
- Performance status - Karnofsky 50-100% (over 16 years of age)
- Performance status - Lansky 50-100% (16 and under)
- Bilirubin ≤ 1.5 times upper limit of normal (ULN) for age
- AST and ALT < 2.5 times ULN for age
- Creatinine adjusted according to age as follows:
- No greater than 0.4 mg/dL (≤ 5 months)
- No greater than 0.5 mg/dL (6 months -11 months)
- No greater than 0.6 mg/dL (1 year-23 months)
- No greater than 0.8 mg/dL (2 years-5 years)
- No greater than 1.0 mg/dL (6 years-9 years)
Where it is running
- Children's Oncology Group — Arcadia, California, United States
- Southern California Permanente Medical Group — Downey, California, United States
- Children's Hospital Los Angeles — Los Angeles, California, United States
- Yale University — New Haven, Connecticut, United States
- Lombardi Comprehensive Cancer Center at Georgetown University — Washington D.C., District of Columbia, United States
- Children's Healthcare of Atlanta - Egleston — Atlanta, Georgia, United States
- University of Illinois — Chicago, Illinois, United States
- Duke University Medical Center — Durham, North Carolina, United States
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
- Baylor College of Medicine — Houston, Texas, United States
- M D Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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