TerminatedPhase 2

Intra-arterial Chemotherapy for the Treatment of Intraocular Retinoblastoma

Stopped: IAC is now recognized as part of standard of care treatment options in the US.

United States10 participantsStarted 2011-03

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of Patients Who Complete Therapy Without the Need for Additional Treatment Including Systemic Chemotherapy, External Beam Radiation, or Enucleation.

Timeframe: Within the first six months after the initial treatment.

Trial details

NCT IDNCT01293539

SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-08

Results submitted2017-06-22

View on ClinicalTrials.gov More Retinoblastoma trials