Trial of Systemic Neoadjuvant Chemotherapy for Group B Intraocular Retinoblastoma
N/A
5 Years
Both
Intraocular Retinoblastoma
Trial Information
Trial of Systemic Neoadjuvant Chemotherapy for Group B Intraocular Retinoblastoma
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 standardized local ophthalmic therapy.
SECONDARY OBJECTIVES:
I. Determine the response rate after one course of chemoreduction (before standardized local
ophthalmic therapy) in these patients.
II. Correlate response rate with event-free survival in patients treated with this regimen.
III. Determine the incidence of toxic effects in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive chemoreduction comprising carboplatin IV over 60 minutes followed by
vincristine IV over 1-2 minutes on day 1. Treatment repeats every 28 days for 6 courses in
the absence of disease progression or unacceptable toxicity. After the first course of
chemoreduction, patients undergo standardized local ophthalmic therapy comprising local
laser therapy, cryotherapy, and/or radioactive plaque comprising iodine I 125 or ruthenium
Ru 106.
Patients are followed every 3-4 weeks until there is no active tumor seen on a minimum of 3
ophthalmic exams under anesthesia, every 6-8 weeks until 3 years of age, every 4-6 months
until 10 years of age, and then annually thereafter.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Event-free survival
Outcome Description:
Observed survival experience to the expected distribution using a method adapted from Woolson will be used. The difference between the number of observed and expected failures is approximately normally distributed with independent increments and may be used for interim monitoring using standard group sequential boundaries. Outcome data will be formally reviewed, using the Lan-DeMets α-spending function implementation of sequential boundaries, after every expected failure, corresponding approximately to 33%, 66% and 100% of the expected information.
Outcome Time Frame:
At 2 years
Safety Issue:
No
Principal Investigator
Debra Friedman
Investigator Role:
Principal Investigator
Investigator Affiliation:
Children's Oncology Group
Authority:
United States: Institutional Review Board
Study ID:
ARET0331
NCT ID:
NCT00079417
Start Date:
December 2005
Completion Date:
Related Keywords:
- Intraocular Retinoblastoma
- Retinoblastoma
Name | Location |
|---|---|
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |
| Children's Oncology Group | Arcadia, California 91006-3776 |
