Retinoblastoma Clinical Trial
Official title:
Evaluation of Chemotherapy as Initial Treatment for 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.
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.
;
Primary Purpose: Treatment
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