Intra-arterial Chemotherapy for the Treatment of Intraocular Retinoblastoma

• Status: Terminated
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Treatments: Melphalan

Criteria

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