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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


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, 

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