Carboplatin Plus Vincristine in Treating Children With Retinoblastoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of carboplatin plus vincristine in treating children with retinoblastoma.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Evaluation of Chemotherapy as Initial Treatment for Retinoblastoma|
|Study Start Date:||February 1996|
|Study Completion Date:||June 2001|
|Primary Completion Date:||June 2001 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Estimate the objective response rate in infants and children with retinoblastoma when treated with carboplatin (CBDCA) and vincristine (VCR) every 3 weeks for 24 weeks. II. Assess the success of this regimen in delaying radiotherapy and eliminating the need for surgery by estimating the cumulative incidence function of treatment failure. III. Estimate the cumulative incidence of failure of this regimen as measured by subsequent treatment with radiotherapy or surgery.
OUTLINE: All patients receive carboplatin and vincristine every 3 weeks for a maximum of 8 courses. Patients with disease progression after at least 2 courses are removed from study and considered for alternative therapy. Patients are followed every 6 weeks for 1 year, every 2 months for 1 year, every 3-4 months for 3 years, and yearly for 12 years.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 4.5 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002794
|United States, Tennessee|
|University of Tennessee, Memphis Cancer Center|
|Memphis, Tennessee, United States, 38103|
|Saint Jude Children's Research Hospital|
|Memphis, Tennessee, United States, 38105-2794|
|Study Chair:||Carlos Rodriguez-Galindo, MD||St. Jude Children's Research Hospital|