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Evaluation of Chemotherapy as Initial Treatment for Retinoblastoma

Phase 2
10 Years
Not Enrolling

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Trial Information

Evaluation of Chemotherapy as Initial Treatment for 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.

Inclusion Criteria

DISEASE CHARACTERISTICS: Newly diagnosed retinoblastoma Bilateral or multifocal unilateral
disease in children under age 10 Unilateral, multifocal tumors less than 5 dd in children
under age 2 No metastatic disease Disease evidenced by ophthalmoscopic/imaging exam,
ultrasound, CT, or MRI Fundus drawings and photographs required

PATIENT CHARACTERISTICS: Age: 10 and under Performance status: Not specified Life
Expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery:
Not specified

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Carlos Rodriguez-Galindo, MD

Investigator Role:

Study Chair

Investigator Affiliation:

St. Jude Children's Research Hospital


United States: Federal Government

Study ID:




Start Date:

February 1996

Completion Date:

June 2001

Related Keywords:

  • Retinoblastoma
  • intraocular retinoblastoma
  • Retinoblastoma



University of Tennessee, Memphis Cancer Center Memphis, Tennessee  38103
Saint Jude Children's Research Hospital Memphis, Tennessee  38105-2794