Study and Treatment Plan for Children with Intraocular Retinoblastoma

Sponsor: St. Jude Children's Research Hospital

Sponsor score: 60

ClinicalTrials ID:NCT01783535

This clinical trial is designed to evaluate the effectiveness of different treatments for children with intraocular retinoblastoma, a type of eye cancer. The study aims to preserve vision and cure the disease using various therapies, including chemotherapy, cryotherapy, and surgery, if necessary.

Patient Parameters

Program Overview

The main goal of this study is to see how well chemotherapy, given directly into the eye, works for children with advanced retinoblastoma in one or both eyes. Researchers also want to learn more about how this cancer develops by studying tissue samples. The study offers a range of treatments to try to save the eye and vision while curing the cancer. All children with non-spreading retinoblastoma at St. Jude can join this study.

Description

Children in the study will be divided into four groups based on whether the cancer is in one or both eyes and how advanced it is. The study will also look at how the cancer affects children's development and how the body processes the drug topotecan.

Treatment Plan

Group A:

  • Children 6 months or older: 8 cycles of vincristine and carboplatin every 3-4 weeks.
  • Infants under 6 months: 6 cycles of chemotherapy, alternating between vincristine-carboplatin and vincristine-topotecan every 3-4 weeks.
  • Additional treatments like cryotherapy and laser therapy may be used as needed.

Group B:

  • Children without extensive cancer spread in the eye: 2 cycles of vincristine and topotecan every 3-4 weeks.
  • If the cancer responds well, more cycles of vincristine-topotecan and vincristine-carboplatin will follow.
  • If the cancer does not respond well, 6 cycles of vincristine-carboplatin-etoposide will be given.
  • Children with extensive cancer spread will receive different combinations of these drugs based on their response.

Group C:

  • Children with advanced cancer in one eye will have the eye removed.
  • Depending on the cancer's spread, some may receive additional chemotherapy or radiation.

Group D:

  • Children with cancer in both eyes may have one eye removed if the disease is advanced.
  • Treatment for the remaining eye will depend on the cancer's stage and the removed eye's condition.
  • Additional treatments may include chemotherapy and radiation.

Focal treatments like cryotherapy and laser therapy will be used as needed.

Inclusion Criteria:

  • Newly diagnosed with intraocular retinoblastoma.
  • Children who have had surgery or focal therapy for one eye and then develop cancer in the other eye can join.
  • Must have good liver and kidney function.
  • Legal guardians must agree to the study and understand the potential benefits and risks.

Exclusion Criteria:

  • Children who have already received treatment for retinoblastoma.
  • Cancer that has spread beyond the eye.
  • Active infections at the time of joining the study.
  • Legal guardians who do not agree to participate.

Eligibility Criteria

Inclusion Criteria

  • Newly diagnosed with intraocular retinoblastoma.
  • Children who have had surgery or focal therapy for one eye and then develop cancer in the other eye can join.
  • Must have good liver and kidney function.
  • Legal guardians must agree to the study and understand the potential benefits and risks.

Exclusion Criteria

  • Children who have already received treatment for retinoblastoma.
  • Cancer that has spread beyond the eye.
  • Active infections at the time of joining the study.
  • Legal guardians who do not agree to participate.

Locations

FACILITYZIPCITYSTATE
St. Jude Children's Research Hospital38105MemphisTennessee

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