Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01783535 : Protocol for the Study and Treatment of Participants With Intraocular Retinoblastoma
PhasePhase 2
AgesMin: N/A Max: N/A
Eligibility
Inclusion Criteria:

- Newly diagnosed, untreated intraocular retinoblastoma. Participants previously
diagnosed with unilateral retinoblastoma treated surgically, with focal therapy or
needing chemotherapy who develop asynchronous involvement of the contralateral eye,
or patients with unilateral retinoblastoma treated only with enucleation or focal
therapy who develop asynchronous involvement of the contralateral eye, will be
eligible for study.

- ECOG Performance Score must be ? 2 within two weeks prior to registration.

- Participants must have an adequate liver function, as defined by bilirubin ? to 3X
upper limit of normal (ULN), and SGOT and SGPT ? to 3X ULN.

- Participants must have adequate renal function as defined by serum creatinine ? to 3X
ULN for age.

- Legal guardians must sign an informed consent indicating that they are aware of this
study, the possible benefits, and toxic side effects. Legal guardians will be given a
signed copy of the consent form.

Exclusion Criteria:

- Previously treated participants.

- Presence of metastatic disease or gross (residual) orbital involvement

- Participants must not have an invasive infection at time of protocol entry.

- Inability or unwillingness of research participant or legal guardian/representative
to give written informed consent.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01783535      |      Link to official Clinicaltrials.gov listing
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