Status:
COMPLETED
Systemic Chemotherapy and Subtenon Carboplatin, and Local Ophthalmic Therapy in Children With Intraocular Retinoblastoma
Lead Sponsor:
Children's Oncology Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Intraocular Retinoblastoma
Eligibility:
All Genders
Up to 17 years
Phase:
PHASE3
Brief Summary
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 ...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the event-free survival at 12 months of pediatric patients' eyes with group D intraocular retinoblastoma treated with systemic chemotherapy comprising vincristine, ca...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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)
- No greater than 1.2 mg/dL (10 years-12 years)
- No greater than 1.4 mg/dL (13 years and over \[female\])
- No greater than 1.5 mg/dL (13 years to 15 years \[male\])
- No greater than 1.7 mg/dL (16 years and over \[male\])
- Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min/1.73m\^2
- Not pregnant or nursing
- Fertile patients must use effective contraception
- Negative pregnancy test in postmenarchal females
- No prior chemotherapy
- No other concurrent chemotherapy
- No prior radiotherapy
- No other concurrent radiotherapy
Exclusion
Key Trial Info
Start Date :
April 16 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00072384
Start Date
April 16 2007
End Date
June 30 2021
Last Update
July 30 2021
Active Locations (11)
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1
Children's Oncology Group
Arcadia, California, United States, 91006-3776
2
Southern California Permanente Medical Group
Downey, California, United States, 90242
3
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
4
Yale University
New Haven, Connecticut, United States, 06520-8032