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Carboplatin Plus Vincristine in Treating Children With Retinoblastoma

NCT ID: NCT00002794

Last Updated: 2011-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-02-29

Study Completion Date

2001-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Retinoblastoma

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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carboplatin

Intervention Type DRUG

vincristine sulfate

Intervention Type DRUG

Eligibility Criteria

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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 specified

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

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

St. Jude Children's Research Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Carlos Rodriguez-Galindo, MD

Role: STUDY_CHAIR

St. Jude Children's Research Hospital

Locations

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University of Tennessee, Memphis Cancer Center

Memphis, Tennessee, United States

Site Status

Saint Jude Children's Research Hospital

Memphis, Tennessee, United States

Site Status

Countries

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United States

Related Links

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http://www.stjude.org

St. Jude Children's Research Hospital

Other Identifiers

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P30CA021765

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P01CA023099

Identifier Type: NIH

Identifier Source: secondary_id

View Link

SJCRH: RET3

Identifier Type: -

Identifier Source: secondary_id

NCI-H96-0935

Identifier Type: -

Identifier Source: secondary_id

CDR0000064874

Identifier Type: -

Identifier Source: org_study_id