Intra-arterial Chemotherapy for the Treatment of Intraocular Retinoblastoma

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Brief Title

Intra-arterial Chemotherapy for the Treatment of Intraocular Retinoblastoma

Official Title

Intra-arterial Chemotherapy for the Treatment of Intraocular Retinoblastoma

Brief 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.
    

Detailed Description

      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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

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


Condition

Retinoblastoma

Intervention

Melphalan hydrochloride

Study Arms / Comparison Groups

 Intraocular Retinoblastoma Patients
Description:  Single group assignment of patients with intraocular retinoblastoma, unilateral or bilateral.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

10

Start Date

March 2011

Completion Date

August 2016

Primary Completion Date

August 2016

Eligibility 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
      

Gender

All

Ages

N/A - 18 Years

Accepts Healthy Volunteers

No

Contacts

Monica Pearl, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01293539

Organization ID

J1071

Secondary IDs

NA_00040637

Responsible Party

Sponsor

Study Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins


Study Sponsor

Monica Pearl, M.D., Principal Investigator, Johns Hopkins University


Verification Date

November 2018