| Inclusion Criteria: | 1) Only patients less than 18 years of age at study entry are eligible.
2) Patients must be enrolled before treatment begins. Treatment must start within 5 calendar days of study enrollment. Patients will begin treatment within 14 days of fulfilling all eligibility criteria. Tests to determine eligibility must be performed within one week prior to enrollment unless otherwise indicated below.
3) Patients must have bilateral retinoblastoma with at least one eye with Group C or D intraocular retinoblastoma confirmed by ophthalmologic examination under anesthesia done within three weeks of study enrollment.
4) Patients will be registered on study based on the local EUA done for diagnostic purposes prior to study entry. The EUA done at study entry must be done within three weeks prior to study entry. RetCam images must be submitted from the diagnostic EUA. This submission must occur within three weeks after study entry. These images will be centrally reviewed within six weeks from study entry to confirm eligibility and International Classification System for Intraocular Retinoblastoma.
5) Patients must have either Group C or Group D intraocular retinoblastoma in at least one eye. GROUP C = Discrete local disease with minimal subretinal or vitreal seeding: Tumor(s) are discrete; Subretinal fluid, present or past without seeding, involving up to one quarter retina; Local fine vitreous seeding may be present close to discrete tumor. - Local subretinal seeding less than 3 mm (2DD) from the tumor.
6) (#5 continued): GROUP D = Diffuse disease with significant vitreous or subretinal seeding: Tumor(s) may be massive or diffuse; Subretinal fluid, present or past without 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. If a patient is found on central review to have neither a C nor a D eye eligible for study, then the patient will be declared inevaluable and will be removed from the study.
7) Performance level must be a score of 50 or greater. Use Karnofsky for patients > 16 years of age and Lansky for patients < / = 16 years of age.
8) A venous access device (VAD) is suggested but not required for protocol therapy.
9) Patients may have had enucleation of one eye, as long as the remaining eye is either Group C or D. Patients must not have received any prior chemotherapy or radiotherapy.
10) Adequate renal function defined as: (1) Creatinine clearance or radioisotope GFR > / = 70 mL/min/1.73 m^2; OR, (2) maximum serum creatinine (md/dL) based on age/gender as follows: 1 month to < 6 months: 0.4 md/dL; 6 months to < 1 yr: 0.5 md/dL; 1 to < 2 yrs: 0.6 md/dL; 2 to < 6 yrs: 0.8 md/dL; 6 to < 10 yrs: 1 md/dL; 10 to < 13 yrs: 1.2 md/dL; 13 to < 16 yrs: Male: 1.5 md/dL; Female: 1.4 md/dL; > / = 16 yrs: Male: 1.7 md/dL; Female: 1.4 mg/dL.
11) Adequate liver function defined as: 1) Total bilirubin should be less than or equal to 1.5 x upper limit of normal (ULN) for age; and, 2) SGOT (AST) and SGPT (ALT) < 2.5 x upper limit of normal (ULN) for age.
12) Negative serum Beta- HCG in post menarchal females.
13) Use of adequate contraception in males and females of child bearing age.
14) All patients and/or their parents or legal guardians must sign a written informed consent.
15) All institutional, FDA, and NCI requirements for human studies must be met. |