Intravitreal Carboplatin for the Treatment of Participants With Recurrent or Refractory Intraocular Retinoblastoma

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Brief Title

Intravitreal Carboplatin for the Treatment of Participants With Recurrent or Refractory Intraocular Retinoblastoma

Official Title

Intravitreal Carboplatin for the Treatment of Participants With Recurrent or Refractory Intraocular Retinoblastoma

Brief Summary

      Retinoblastoma (RB) is the most common intraocular tumor of childhood. Recurrent or
      refractory disease following therapy most often occurs due to persistence of vitreous disease
      and/or retinal reactivation of the main tumor mass. With this treatment protocol,
      investigators seek to identify a less invasive method of local drug delivery that does not
      disrupt the eye's integrity.

      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.

      SECONDARY OBJECTIVES:

        -  To estimate the ocular salvage rate after treatment with intravitreal carboplatin in
           patients with recurrent or progressive intraocular retinoblastoma with vitreous seeding.

        -  To evaluate the effects of intravitreal carboplatin therapy on the histopathology of
           eyes enucleated for progressive or recalcitrant disease while on therapy.
    

Detailed Description

      The eye(s) will be sterilized prior to injection. Aqueous fluid (0.1-0.15ml) will be
      withdrawn and sent for pathology review. Carboplatin diluted in normal saline will be
      administered via intravitreal injection under anesthesia once to each eligible eye
      approximately every 14 days. Following the injection, triple freeze/thaw cryotherapy is
      applied to the injection site and the eye is washed with water. The eye is gently "shaken" in
      all directions to evenly distribute the drug.

      This trial will use a traditional phase I design for dose de-escalation with two dose levels.
      The first 6 patients will be enrolled at dose level 1 and will be observed for dose-limiting
      toxicity (DLT) throughout the treatment period up to approximately 5 months after start of
      therapy. If 0-2 (of the first 6) participants experience DLT, a second cohort of 6 patients
      will be enrolled at the same dose level 1. Study accrual would be completed at 12.

      However, if 3 or more of the first 6 patients experience DLT at dose level 1, the dose level
      would be de-escalated to level -1 and 6 patients enrolled at this level (dose -1). If 0-2
      patients experience DLT at dose level -1, a second cohort of 6 patients will be enrolled at
      dose level -1, and the study accrual would be complete. If 3 or more patients experience DLT
      at dose level -1, accrual would also be complete.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Number of participants who develop dose-limiting toxicity (DLT)


Condition

Retinoblastoma

Intervention

Carboplatin

Study Arms / Comparison Groups

 Treatment
Description:  Participants with retinoblastoma that is refractory or has relapsed inside the eye.
Interventions: Carboplatin, Maxitrol® , focal therapy, plaque radiotherapy.

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

8

Start Date

November 1, 2016

Completion Date

October 4, 2019

Primary Completion Date

October 4, 2019

Eligibility Criteria

        Inclusion Criteria:

          -  Refractory or recurrent retinoblastoma with vitreous seeding meeting eligibility
             criteria by ultrasonic biomicroscopy performed during examination under anesthesia
             (EUA) by an ophthalmologist:

               -  At least three consecutive clock hours of disease-free, attached peripheral
                  retina through which the intraocular injection may be administered.

               -  Absence of invasion in anterior and posterior chamber.

               -  Absence of anterior hyaloid detachment.

               -  Absence of retinal detachment at the entry site.

               -  Absence of tumor at the entry site.

          -  ECOG Performance Score must be ≤ 2 within two weeks prior to registration.

          -  Participants must have an adequate liver function, as defined by bilirubin ≤3 x upper
             limit of normal (ULN), and SGOT and SGPT ≤3 x ULN.

          -  Participants must have adequate renal function as defined by serum creatinine ≤3 x ULN
             for age.

          -  Legal guardians must sign an informed consent indicating that they are aware of this
             study, the possible benefits, and toxic side effects. Legal guardians will be given a
             signed copy of the consent form.

        Exclusion Criteria:

          -  Presence of metastatic disease or gross orbital involvement.

          -  Participants must not have an invasive infection at time of protocol entry.

          -  Inability or unwillingness of research participant or legal guardian/representative to
             give written informed consent.
      

Gender

All

Ages

N/A - 17 Years

Accepts Healthy Volunteers

No

Contacts

Rachel Brennan, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02792036

Organization ID

iRET

Secondary IDs

NCI-2016-00848

Responsible Party

Sponsor

Study Sponsor

St. Jude Children's Research Hospital


Study Sponsor

Rachel Brennan, MD, Principal Investigator, St. Jude Children's Research Hospital


Verification Date

February 2020