This phase III trial is studying how well giving carboplatin and vincristine together with standard local ophthalmic therapy works in treating children with intraocular retinoblastoma. Drugs used in chemotherapy, such as carboplatin and vincristine, work in different ways to stop tumor from dividing so they stop growing or die. It is not yet known whether neoadjuvant chemotherapy combined with standard local ophthalmic therapy is effective in treating intraocular retinoblastoma.
PRIMARY OBJECTIVES: I. Determine the 2-year event-free survival of patients with Group B intraocular retinoblastoma treated with neoadjuvant chemoreduction comprising carboplatin and vincristine and standardized local ophthalmic therapy. SECONDARY OBJECTIVES: I. Determine the response rate after one course of chemoreduction (before standardized local ophthalmic therapy) in these patients. II. Correlate response rate with event-free survival in patients treated with this regimen. III. Determine the incidence of toxic effects in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive chemoreduction comprising carboplatin IV over 60 minutes followed by vincristine IV over 1-2 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the first course of chemoreduction, patients undergo standardized local ophthalmic therapy comprising local laser therapy, cryotherapy, and/or radioactive plaque comprising iodine I 125 or ruthenium Ru 106. Patients are followed every 3-4 weeks until there is no active tumor seen on a minimum of 3 ophthalmic exams under anesthesia, every 6-8 weeks until 3 years of age, every 4-6 months until 10 years of age, and then annually thereafter.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Children's Hospital Los Angeles
Los Angeles, California, United States
Lurie Children's Hospital-Chicago
Chicago, Illinois, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Event-free Survival
Proportion of patients with event free survival at 2 years. An event is defined as the need for non-protocol therapy, defined as additional on-protocol chemotherapy, enucleation or external beam radiation, among patients with Group B intraocular tumors with a schedule of neoadjuvant 2-agent (Vincristine/Carboplatin) chemotherapy (chemo-reduction) and standardized local ophthalmic therapy.
Time frame: At 2 years
Response Rate (RR) at Patient Level After the First Course of Therapy
RR will be estimated. The response after 1 course of chemotherapy will be used to better define response to this neoadjuvant systemic chemotherapy, prior to the use of local ophthalmic therapy. Response to subsequent courses will help define response to combined systemic chemotherapy and local ophthalmic therapy. Number of patients with Type I, II, III or IV response after first course of therapy
Time frame: 1 month after enrollment
Response Rate (RR) at Eye Levels After the First Course of Therapy
RR will be estimated. The response after 1 course of chemotherapy will be used to better define response to this neoadjuvant systemic chemotherapy, prior to the use of local ophthalmic therapy. Response to subsequent courses will help define response to combined systemic chemotherapy and local ophthalmic therapy. Number eyes with Type I, II, III or IV response after first course of therapy
Time frame: 1 month after enrollment
Event-free Survival Rate (EFSR) Defined as the Need for Non-protocol Chemotherapy, Enucleation, or EBRT at the Patient Level
EFSR will be estimated for patients who respond to vincristine and carboplatin after an initial 1 cycle of chemoreduction
Time frame: 2 years after enrollment
Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0
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Undergo radioactive therapy
Undergo radioactive therapy
Undergo radioactive therapy
Given IV
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States
Duke University Medical Center
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Oncology Group
Philadelphia, Pennsylvania, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Participants with Grade 3 and higher reported on protocol therapy
Time frame: 6 months after enrollment