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

Completed · Phase 3

Conditions studied: Intraocular Retinoblastoma

In brief

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 retinoblastoma. Drugs used in chemotherapy, such as vincristine, carboplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, no additional treatment is needed for the tumor until it progresses. In this case, observation may be sufficient.

Key facts

Study ID

NCT00335738

Run by

Children's Oncology Group

People needed

331

Starts

2005-12-01

Expected to finish

2020-09-30

Last updated by the study team

2021-02-18

Who can join

Age: any, up to 6. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

Where it is running

• University of Arizona Health Sciences Center — Tucson, Arizona, United States
• Children's Oncology Group — Arcadia, California, United States
• Southern California Permanente Medical Group — Downey, California, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Rady Children's Hospital - San Diego — San Diego, California, United States
• University of California San Francisco Medical Center-Parnassus — San Francisco, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Lombardi Comprehensive Cancer Center at Georgetown University — Washington D.C., District of Columbia, United States
• University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida, United States
• University of Illinois — Chicago, Illinois, United States
• Childrens Memorial Hospital — Chicago, Illinois, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• University of Kentucky — Lexington, Kentucky, United States
• Kosair Children's Hospital — Louisville, Kentucky, United States
• Maine Children's Cancer Program — Scarborough, Maine, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Wayne State University — Detroit, Michigan, United States
• University of Minnesota Medical Center-Fairview — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• The Childrens Mercy Hospital — Kansas City, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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