Carboplatin Plus Vincristine in Treating Children With Retinoblastoma

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Brief Title

Carboplatin Plus Vincristine in Treating Children With Retinoblastoma

Official Title

Evaluation of Chemotherapy as Initial Treatment for Retinoblastoma

Brief 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.
    

Detailed 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.
    

Study Phase

Phase 2

Study Type

Interventional




Condition

Retinoblastoma

Intervention

carboplatin


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

25

Start Date

February 1996

Completion Date

June 2001

Primary Completion Date

June 2001

Eligibility 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
      

Gender

All

Ages

N/A - 10 Years

Accepts Healthy Volunteers

No

Contacts

Carlos Rodriguez-Galindo, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00002794

Organization ID

CDR0000064874

Secondary IDs

P30CA021765


Study Sponsor

St. Jude Children's Research Hospital

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Carlos Rodriguez-Galindo, MD, Study Chair, St. Jude Children's Research Hospital


Verification Date

October 2011