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Trial Summary


Protocol No.PHO-COG-FALLON-ARET0321
StatusCLOSED TO ACCRUAL
Principal InvestigatorBatra, Sandeep
ScopeNational
PhasePhase III
Age GroupChildren
TitleA Trial of Intensive Multi-Modality Therapy for Extra-Ocular Retinoblastoma
DescriptionThis phase III trial is studying the side effects and how well giving combination chemotherapy together with autologous stem cell transplant and/or radiation therapy works in treating young patients with extraocular retinoblastoma. Giving chemotherapy before an autologous stem cell transplant stops the growth of tumor cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood and/or bone marrow and stored. More chemotherapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Radiation therapy uses high energy x-rays to kill tumor cells. Giving radiation therapy after combination chemotherapy and/or autologous stem cell transplant may kill any remaining tumor cells.
Key EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:

  • Be 10 years of age or younger
  • Have a histologic or cytologic verification of extra-ocular retinoblastoma; extra-ocular disease includes orbital disease, optic nerve involvement at the surgical margin, regional nodal disease, and/or overt distant metastatic disease (at sites such as bone, bone marrow, liver and/or the central nervous system); patients with trilateral retinoblastoma will also be included in this protocol
  • Have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age
  • Have had no prior chemotherapy or radiotherapy for the extra-ocular retinoblastoma may have been administered prior to entering this study; prior treatment (chemotherapy and/or radiation therapy) for intra-ocular retinoblastoma is permissible
For a full list of participation criteria, please visit clinicaltrials.gov.
Applicable Disease SitesEye and Orbit
Participating InstitutionsIndiana University (IU)
    Treatment TypeTreatment
    ContactMelissa Lee, Phone: +1 317-944-4281
    Pager: 312-1228
    Email: mellee@iu.edu