Study of Treatment for Patients With Cancer of the Eye -Retinoblastoma

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Brief Title

Study of Treatment for Patients With Cancer of the Eye -Retinoblastoma

Official Title

Protocol for the Study and Treatment of Patients With Intraocular Retinoblastoma

Brief Summary

      Retinoblastoma is a childhood cancer which affects the retina of the eye. The retina is the
      light sensitive layer of tissue that lines the back of the eyeball; sends visual messages
      through the optic nerve to the brain. When only one eye is affected, this is known as
      unilateral retinoblastoma and when both eyes are affected, it is called bilateral
      retinoblastoma. Treatment for retinoblastoma is individualized for each patient and is based
      on the form and the stage of the disease (inside the eye or has moved outside). The main goal
      is always to cure the cancer, and save the life of the child. Treatments are also designed
      with the hope of saving the vision, while completely destroying the tumor. Therapies may
      involve surgery, chemotherapy, radiation, and other treatments called focal treatments. Focal
      treatments may be laser therapy, freezing, or heat treatments meant to shrink and kill the
      tumor.

      In this study, researchers want to investigate how different participants respond to
      different therapies that are individualized specifically for them. Participants will be
      divided into three main groups, depending on whether the disease is unilateral or bilateral,
      and the stage of the disease. One of the main objectives of the study is to investigate how
      advanced tumors in children with bilateral disease respond to a new combination of
      chemotherapy with topotecan and vincristine, with G-CSF support. In order to improve results,
      some children with very advanced disease may receive carboplatin chemotherapy given around
      the eye at the same time that they receive topotecan by vein. Also, because children with
      retinoblastoma are diagnosed so early in life and the vision may be significantly impaired,
      this study will investigate how children develop and how the brain adjusts and compensates
      for the visual deficits. Finally, this study also investigates the biology of retinoblastoma,
      in order to understand better how this cancer develops.
    

Detailed Description

      This study will determine the following:

      PRIMARY OBJECTIVE:

        -  To estimate the ocular survival and event-free survival of bilateral disease patients
           with advanced intraocular retinoblastoma in either eye (R-E IV-V) responding to the
           vincristine/topotecan window, with alternating cycles of vincristine and carboplatin
           with vincristine, topotecan, and periocular carboplatin, with intensive focal
           treatments.

      SECONDARY OBJECTIVES:

        -  To estimate the ocular survival of eye and event-free survival of eye of bilateral
           disease patients with advanced intraocular retinoblastoma in either eye (R-E IV-V)
           responding to the vincristine/topotecan window, with alternating cycles of vincristine
           and carboplatin with vincristine, topotecan, and periocular carboplatin, with intensive
           focal treatments.

        -  To estimate the ocular survival and event free survival of patients with advanced
           intraocular retinoblastoma (R-E IV-V) not responding to the vincristine/topotecan
           window, with a combination of vincristine, carboplatin, etoposide, and periocular
           carboplatin, with intensive focal treatments.

        -  To estimate the ocular survival and event free survival of eye of patients with advanced
           intraocular retinoblastoma (R-E IV-V) not responding to the vincristine/topotecan
           window, with a combination of vincristine, carboplatin, etoposide, and periocular
           carboplatin, with intensive focal treatments.

        -  To estimate the ocular survival and event-free survival of patients with early stage
           intraocular retinoblastoma (R-E I-III) with vincristine and carboplatin with intensive
           focal treatments.

        -  To estimate the ocular survival of eye and event-free survival of eye of patients with
           early stage intraocular retinoblastoma (R-E I-III) with vincristine and carboplatin with
           intensive focal treatments.

        -  To estimate the response rate of early stage eyes (R-E I-III) in patients with
           contralateral advanced disease treated with vincristine and topotecan.

        -  To estimate the ocular survival and event-free survival of early stage eyes (R-E I-III)
           of patients with contralateral advanced disease treated with vincristine and topotecan.

        -  To describe the outcome of intraocular retinoblastoma with respect to the new
           International Classification for Intraocular Retinoblastoma and the AJCC.

        -  To describe primary visual cortex function in patients with unilateral and bilateral
           retinoblastoma.

        -  To describe the cognitive, adaptive, and social/emotional development of children with
           retinoblastoma.

        -  To describe changes in the pineal gland during treatment in patients with bilateral
           retinoblastoma.

        -  To assess the relation between CYP3A4/5 genotype and the pharmacokinetics and
           pharmacodynamics of topotecan.

        -  To assess the relation between ABCG2 genotype and the pharmacokinetics and
           pharmacodynamics of topotecan.

        -  To determine if carboplatin can produce changes in cochlear function that are detectable
           with measurement of otoacoustic emissions.

        -  To evaluate the need for and feasibility of starting early intervention support during
           the first year after the diagnosis of retinoblastoma.

      EXPLORATORY OBJECTIVES:

        -  To provide insight into molecular pathogenesis of retinoblastoma.

        -  To describe the incidence and type of germline mutations of the RB gene in patients with
           retinoblastoma.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Stratum B Response to Window Therapy

Secondary Outcome

 Stratum B Response Rate of Early Stage Eyes to Window Therapy

Condition

Retinoblastoma

Intervention

Enucleation

Study Arms / Comparison Groups

 Stratum A
Description:  Patients with early bilateral or unilateral, or patients with bilateral that have already had the advanced eye enucleated. Treatment included vincristine and carboplatin for 8 courses, given at 3-4 week intervals. Focal therapies any time after second course can include cryotherapy, laser photocoagulation, thermotherapy, and 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

Procedure

Estimated Enrollment

107

Start Date

April 7, 2005

Completion Date

September 2021

Primary Completion Date

November 2013

Eligibility Criteria

        Inclusion Criteria:

          -  Must have newly diagnosed intraocular retinoblastoma, previously untreated. Patients
             previously diagnosed with unilateral retinoblastoma treated surgically (or with focal
             therapies), who develop asynchronous involvement of the contralateral eye, will be
             eligible for study.

          -  Must have a life expectancy of at least 8 weeks.

          -  Must have Performance Status (ECOG) of 0-2.

          -  Patients must have an adequate liver function, as defined by bilirubin less than or
             equal to 3 x normal, and SGOT and SGPT less than or equal to 3x normal.

          -  Patients must have adequate renal function as defined by serum creatinine less than or
             equal to 3x normal for age.

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

        Exclusion Criteria:

          -  Previously treated patients

          -  Presence of metastatic disease or orbital involvement

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

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Ibrahim Qaddoumi, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00186888

Organization ID

RET5

Secondary IDs

P01CA023099

Responsible Party

Sponsor

Study Sponsor

St. Jude Children's Research Hospital

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Ibrahim Qaddoumi, M.D., Principal Investigator, St. Jude Children's Research Hospital


Verification Date

February 2021