A Single Arm Trial of Systemic And Subtenon Chemotherapy For Groups C And D Intraocular Retinoblastoma
I. 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)
I. 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.
II. Determine the acute and long-term toxic effects of these regimens in these patients,
including visual outcome and incidence of secondary malignancies.
III. Determine the patterns of failure in patients treated with these regimens, in terms of
vitreous vs retinal vs both as sites of recurrence.
IV. Determine predictors of failure including findings at the on study examination under
anesthesia and response status after six courses of chemotherapy.
V. 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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of failure-free survival of patients with group C and/or D retinoblastoma
The observed failure proportion for group D eyes will be compared to the historical proportion of 0.70 using a method suggested by Rosner. The proportion of group C eyes that fail will be compared to the historical probability of 0.40 using the same method.
At 1 year
Children's Oncology Group
United States: Food and Drug Administration
|Baylor College of Medicine||Houston, Texas 77030|
|Children's Hospital Los Angeles||Los Angeles, California 90027-0700|
|Southern California Permanente Medical Group||Downey, California 90242|
|Cincinnati Children's Hospital Medical Center||Cincinnati, Ohio 45229-3039|
|Duke University Medical Center||Durham, North Carolina 27710|
|Yale University||New Haven, Connecticut 06520|
|M D Anderson Cancer Center||Houston, Texas 77030|
|Lombardi Comprehensive Cancer Center at Georgetown University||Washington, District of Columbia 20057|
|University of Illinois||Chicago, Illinois 60612|
|Children's Oncology Group||Arcadia, California 91006-3776|
|Children's Healthcare of Atlanta - Egleston||Atlanta, Georgia 30322|