Intra-arterial Chemotherapy for the Treatment of Intraocular Retinoblastoma



Status:Terminated
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any - 18
Updated:11/29/2018
Start Date:March 2011
End Date:August 2016

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The purpose of this study is to show that chemotherapy delivered directly through the artery
supplying the eye (ophthalmic artery) to patients with retinoblastoma is a safe and effective
treatment alternative to conventional systemic chemotherapy, external beam radiation, and
surgical removal of the eye.

Delivering the chemotherapeutic agent in the arterial system through the ophthalmic artery
transforms the treatment of retinoblastoma from systemic chemotherapy to local chemotherapy.
Administration of the drug directly to the targeted site thus avoids the complications and
adverse events associated with toxicity from systemic, rather than local, chemotherapy.

Inclusion Criteria:

- Patients newborn to 18 years old.

- Patients with intraocular retinoblastoma, unilateral or bilateral, who would be
treated either by systemic chemotherapy, EBR, or enucleation would be considered for
this study.

Exclusion Criteria:

- Patients over the age of 18.

- Patients with small, localized intraocular Rb amenable to focal therapy (laser or
cryotherapy).

- Patients with extraocular disease evident on MRI (extension into the optic nerve),
massive choroidal/uveal invasion (grade IIC or IID per ARET0332) or disease outside
the globe evident on MRI or physical examination.

- Documented hypercoagulable disorders or vasculopathies.

- Laboratory exclusion criteria: GFR < 60 mL/min/1.73 m2
We found this trial at
1
site
1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
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