Intra-arterial Chemotherapy for the Treatment of Intraocular Retinoblastoma

Stopped early · Phase 2

Conditions studied: Retinoblastoma

In brief

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.

Key facts

Study ID

NCT01293539

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

10

Starts

2011-03-01

Expected to finish

2016-08-01

Last updated by the study team

2018-11-27

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• The Johns Hopkins Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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