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Status:

COMPLETED

Vincristine, Carboplatin, and Etoposide or Observation Only in Treating Patients Who Have Undergone Surgery for Newly Diagnosed Retinoblastoma

Lead Sponsor:

Children's Oncology Group

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Intraocular Retinoblastoma

Eligibility:

All Genders

Up to 6 years

Phase:

PHASE3

Brief Summary

This phase III trial is studying vincristine, carboplatin, and etoposide to see how well they work compared to observation only in treating patients who have undergone surgery for newly diagnosed reti...

Detailed Description

OBJECTIVES: I. Prospectively determine the prevalence of high-risk histopathologic features, such as choroidal involvement, optic nerve invasion, and scleral and anterior segment involvement, in pati...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Newly diagnosed unilateral retinoblastoma
  • Underwent enucleation as primary therapy within the past 5 weeks
  • Must enroll and submit pathology slides within 21 days of enucleation
  • Adjuvant chemotherapy must begin within 35 days after enucleation
  • Disease with or without high-risk histopathologic features
  • High-risk features are defined as any of the following:
  • Posterior uveal invasion (includes choroidal invasion)
  • Any degree of concomitant choroid and/or optic nerve involvement
  • Tumor involving the optic nerve posterior to the lamina cribrosa as an independent finding
  • Scleral invasion
  • Anterior chamber seeding
  • Ciliary body infiltration
  • Iris infiltration
  • No evidence of extraocular retinoblastoma clinically, by CT scan, or by MRI of the brain and orbits with and without gadolinium
  • No tumor at the cut end of the optic nerve on any eye enucleated as evidenced by histologic examination prior to study entry
  • No systemic metastases as evidenced by bone marrow scan, bone scan, or any other additional test at study entry
  • Lansky performance status 50-100%
  • Hemoglobin \> 8 g/dL
  • Absolute neutrophil count ≥ 1,000/mm³
  • Platelet count ≥ 100,000/mm³
  • Creatinine adjusted according to age as follows:
  • No greater than 0.4 mg/dL (≤ 5 months)
  • No greater than 0.5 mg/dL (6 months -11 months)
  • No greater than 0.6 mg/dL (1 year-23 months)
  • No greater than 0.8 mg/dL (2 years-5 years)
  • No greater than 1.0 mg/dL (6 years-9 years)
  • No greater than 1.2 mg/dL (10 years-12 years)
  • No greater than 1.4 mg/dL (13 years and over \[female\])
  • No greater than 1.5 mg/dL (13 years to 15 years \[male\])
  • No greater than 1.7 mg/dL (16 years and over \[male\])
  • Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN) for age
  • AST or ALT \< 2.5 times ULN for age
  • No prior therapy other than enucleation
  • No prior chemotherapy

Exclusion

    Key Trial Info

    Start Date :

    December 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    September 30 2020

    Estimated Enrollment :

    331 Patients enrolled

    Trial Details

    Trial ID

    NCT00335738

    Start Date

    December 1 2005

    End Date

    September 30 2020

    Last Update

    February 18 2021

    Active Locations (56)

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    Page 1 of 14 (56 locations)

    1

    University of Alabama at Birmingham

    Birmingham, Alabama, United States, 35294

    2

    University of Arizona Health Sciences Center

    Tucson, Arizona, United States, 85724

    3

    Children's Oncology Group

    Arcadia, California, United States, 91006-3776

    4

    Southern California Permanente Medical Group

    Downey, California, United States, 90242