Carboplatin Plus Vincristine in Treating Children With Retinoblastoma

Retinoblastoma Clinical Trial

Official title:

Evaluation of Chemotherapy as Initial Treatment for Retinoblastoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002794
• Other study ID #: CDR0000064874
• Secondary ID: P30CA021765P01CA
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: October 3, 2011
• Start date: February 1996
• Est. completion date: June 2001

Study information

• Verified date: October 2011
• Source: St. Jude Children's Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 2001
• Est. primary completion date: June 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 10 Years

Eligibility

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 specified

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Retinoblastoma

Intervention

Drug:
• carboplatin

• vincristine sulfate

Locations

Country	Name	City	State
United States	Saint Jude Children's Research Hospital	Memphis	Tennessee
United States	University of Tennessee, Memphis Cancer Center	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

External Links

•   St. Jude Children's Research Hospital