Systemic Vincristine, Carboplatin, and Etoposide, Subtenon Carboplatin, and Local Ophthalmic Therapy in Treating Children With Intraocular Retinoblastoma
Recruitment status was Active, not recruiting
RATIONALE: 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.
PURPOSE: Phase III trial to determine the effectiveness of combining systemic chemotherapy and subtenon carboplatin with ophthalmic therapy in treating children who have intraocular retinoblastoma.
Drug: vincristine sulfate
Procedure: laser surgery
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Single Arm Trial of Systemic And Subtenon Chemotherapy For Groups C And D Intraocular Retinoblastoma|
- Event-free survival at 12 months of pediatric patients' eyes with intraocular group C and/or D retinoblastoma [ Designated as safety issue: No ]
- Acute and long-term toxic effects [ Designated as safety issue: Yes ]
- Patterns of failure [ Designated as safety issue: No ]
- Predictors of failure [ Designated as safety issue: No ]
- Percentage of preservation without enucleation after failed treatment [ Designated as safety issue: No ]
|Study Start Date:||April 2007|
|Estimated Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
- Determine the event-free survival at 12 months of pediatric patients' eyes with group D intraocular retinoblastoma treated with systemic chemotherapy comprising vincristine, carboplatin, and etoposide, subtenon carboplatin, and local ophthalmic therapy. (Event defined for each eye individually as needed for nonprotocol therapy including nonprotocol chemotherapy, enucleation or any external-beam radiation)
- Determine the event-free survival at 12 months of pediatric patients' eyes with group C retinoblastoma treated with systemic chemotherapy comprising carboplatin, etoposide, vincristine, subtenon carboplatin, and local ophthalmic therapy.
- Determine the acute and long-term toxic effects of these regimens in these patients, including visual outcome and incidence of secondary malignancies.
- Determine the patterns of failure in patients treated with these regimens, in terms of vitreous vs retinal vs both as sites of recurrence.
- Determine predictors of failure including findings at the on study examination under anesthesia and response status after six courses of chemotherapy.
- Determine the percentage of group C and D eyes separately that can be preserved without enucleation after failing protocol therapy.
OUTLINE: This is a multicenter study.
Patients receive vincristine IV over 1 minute on day 1 and carboplatin IV over 1 hour and etoposide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on day 3 and continuing until blood counts recover. Patients receive subtenon carboplatin to each group C or D eye on day 0 or 1 prior of courses 2-4 only. Treatment repeats every 28 days for 6 courses in the absence of occurrence of extraocular retinoblastoma or a second malignancy. Beginning with course 3 of systemic chemotherapy, patients undergo local ophthalmic therapy comprising local laser and/or cryotherapy on day 1.
Patients are followed with ophthalmology exams every 4-12 weeks until 3 years of age, every 6 months until 5 years of age, and then annually for up to 10 years.
PROJECTED ACCRUAL: A total of 69 patients will be accrued for this study within 3 years.
|United States, California|
|Southern California Permanente Medical Group|
|Downey, California, United States, 90027|
|Childrens Hospital Los Angeles|
|Los Angeles, California, United States, 90027|
|United States, Connecticut|
|Yale Cancer Center|
|New Haven, Connecticut, United States, 06520-8028|
|United States, Delaware|
|Alfred I. duPont Hospital for Children|
|Wilmington, Delaware, United States, 19803|
|United States, District of Columbia|
|Lombardi Comprehensive Cancer Center at Georgetown University Medical Center|
|Washington, District of Columbia, United States, 20007|
|United States, Florida|
|Nemours Children's Clinic|
|Jacksonville, Florida, United States, 32207|
|University of Miami Sylvester Comprehensive Cancer Center - Miami|
|Miami, Florida, United States, 33136|
|United States, Georgia|
|AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus|
|Atlanta, Georgia, United States, 30322|
|United States, Illinois|
|Children's Memorial Hospital - Chicago|
|Chicago, Illinois, United States, 60614|
|University of Illinois Cancer Center|
|Chicago, Illinois, United States, 60612-7243|
|United States, North Carolina|
|Duke Comprehensive Cancer Center|
|Durham, North Carolina, United States, 27710|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229-3039|
|Cleveland Clinic Taussig Cancer Center|
|Cleveland, Ohio, United States, 44195|
|United States, Texas|
|Cook Children's Medical Center - Fort Worth|
|Fort Worth, Texas, United States, 76104|
|M. D. Anderson Cancer Center at University of Texas|
|Houston, Texas, United States, 77030-4009|
|Baylor University Medical Center - Houston|
|Houston, Texas, United States, 77030-2399|
|United States, Washington|
|Children's Hospital and Regional Medical Center - Seattle|
|Seattle, Washington, United States, 98105|
|Australia, New South Wales|
|Children's Hospital at Westmead|
|Westmead, New South Wales, Australia, 2145|
|Study Chair:||Rima Jubran, MD, MPH||Children's Hospital Los Angeles|
|Investigator:||Timothy G. Murray, MD||University of Miami Sylvester Comprehensive Cancer Center|