iRET: Intravitreal Chemotherapy for Children with Retinoblastoma

Intravitreal Carboplatin for the Treatment of Participants with Recurrent or Refractory Intraocular Reintoblastoma

Categories:

Solid Tumor

Phase I/II

Diseases Treated:

Retinoblastoma

Eligibility Overview:

  • Age 17 or younger
  • Diagnosis of retinoblastoma that did not go away with treatment or came back after treatment
  1. Brief Summary

    Retinoblastoma (RB) is the most common intraocular tumor of childhood and represents about 3% of all pediatric cancers. Recurrent or refractory disease following therapy most often occurs due to persistence of vitreous disease and/or retinal reactivation of the main tumor mass. In most cases, the patient has already received systemic therapy. Current therapies for recurrent or refractory retinoblastoma generally focus on radiation or delivery of therapy directly to tumor cells within the eye. Brachytherapy may be an option for a limited number of patients, such as those with localized recurrence and/or limited vitreous seeding.

    New local delivery techniques, such as intravitreal injection, have revolutionized the treatment of recurrent retinoblastoma by enabling direct administration of chemotherapeutic agents into the eye. Previous studies have shown some promise using this technique to treat refractory and recurrent retinoblastoma but have used melphalan. In this study, St. Jude researchers will evaluate carboplatin for intravitreal injection. Patients will undergo ultrasonic biomicroscopy before injecting carboplatin directly into the vitreous.

    Primary Objective

    • To determine the safety and toxicity profile associated with intravitreal carboplatin for the treatment of recurrent or progressive intraocular retinoblastoma with vitreous seeding

    Eligibility Criteria

    Inclusion criteria include:

    • Age 17 or younger
    • Refractory or recurrent retinoblastoma with vitreous seeding meeting eligibility criteria by ultrasonic biomicroscopy:
      • At least 3 consecutive clock hours of disease-free, attached peripheral retina through which the intraocular injection may be administered
    • Adequate liver and renal function
    • ECOG Performance Score less than or equal to 2 within 2 weeks prior to registration

    Exclusion Criteria include:

    • Metastatic disease or gross orbital involvement
    • Invasive infection at time of protocol entry

    Study Sites

    St. Jude Children’s Research Hospital
    Memphis, Tennessee

  2. About this Study

    Retinoblastoma is a pediatric eye cancer that is usually diagnosed before a child reaches the age of 3. If left untreated, the cancer can spread through the eye and into other parts of the body. Standard treatment may include giving cancer fighting medicine called chemotherapy, surgery and/or radiation therapy. Freezing treatments, also called cryotherapy, and laser treatments may also be used.

    Recently, some doctors have started using a new method of giving the chemotherapy drugs directly into the eye of cancer patients. Normally, chemotherapy drugs are given through a vein or IV. With this new technique, the doctor injects the medicine directly into the jelly-like fluid, called vitreous, that fills the eye. This method is called intravitreal injection.

    In this study, St. Jude researchers will use this new method to give a chemotherapy drug called carboplatin to children who have retinoblastoma that did not go away with treatment or came back after treatment. The injections will be given while the child is asleep under anesthesia. Treatments can be given every 2 weeks, and a child may receive up to 8 injections over several weeks. After treatment on this study is completed, each participant will continue to receive care and follow-up for up to 5 years.

    Purpose of this Clinical Trial

    The main purpose of this study is to learn the good and bad effects of injecting carboplatin directly into the vitreous of children and adolescents who have retinoblastoma that is hard to treat.  Researchers also want to know how hard or easy it is to give the injections to these patients. Finally, they want to find out if this method improves the chance of saving the child’s eye.

    Eligibility Overview

    • Age 17 or younger
    • Diagnosis of retinoblastoma that did not go away after treatment or came back after treatment
  3. iRet Quick View
    Sponsor St. Jude Children’s Research Hospital
    ClinicalTrials.gov identifier NCT02792036
    Trial Start Date June 2016
    Estimated Enrollment 18
    Study Type Interventional
    Study Phase Phase I
    Conditions Retinoblastoma
    Ages 17 years or younger
    Principal investigator Rachel C. Brennan, MD
    Study Sites St. Jude Children’s Research Hospital
    For a consultation or to discuss iRET St. Jude Physician/Patient Referral Office
    1-888-226-4343
    referralinfo@stjude.org

Contact

Rachel C. Brennan, MD

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.