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Home > "C" Clinical Trials Conditions > Carboplatin Plus Vincristine in Treating Children With Retinoblastoma  Carboplatin Plus Vincristine in Treating Children With Retinoblastoma
Carboplatin Plus Vincristine in Treating Children With Retinoblastoma
For Condition: intraocular retinoblastoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , St. Jude Children's Research Hospital
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /10 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy - Endocrine therapy: Not specified - Radiotherapy: No prior radiotherapy - Surgery: Not specified --Patient Characteristics-- - Age: 10 and under - Performance status: Not specified - Life Expectancy: Not specified - Hematopoietic: Not specified - Hepatic: Not specified - Renal: Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CharlesPratt, Study Chair, St. Jude Children's Research Hospital
Saint Jude Children's Research Hospital
Memphis, Tennessee, 38105-2794
United States
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, 38103
United States
Additional Information:
Study ID Numbers: CDR0000064874; SJCRH-RET-3,NCI-H96-0935
Study Start Date: February 1996
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002794
Other Intraocular Retinoblastoma Studies:
1. Systemic Vincristine, Carboplatin, and Etoposide, Subtenon Carboplatin, and Local Ophthalmic Therapy With or Without Low-Dose Radiation Therapy in Treating Children With Intraocular Retinoblastoma
2. Carboplatin Plus Vincristine in Treating Children With Retinoblastoma
3. Combination Chemotherapy, Radiation Therapy, and Bone Marrow Transplantation in Treating Patients With Retinoblastoma
4. Neoadjuvant Carboplatin and Vincristine and Standard Local Ophthalmic Therapy in Treating Patients With Intraocular Retinoblastoma
Related Studies:
Other intraocular retinoblastoma Clinical Trials
Other Tennessee Clinical Trials
Other Memphis Clinical Trials
Carboplatin Plus Vincristine in Treating Children With Retinoblastoma
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