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| Sponsor: | St. Jude Children's Research Hospital |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002794 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Retinoblastoma |
Drug: carboplatin Drug: vincristine sulfate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | EVALUATION OF CHEMOTHERAPY AS INITIAL TREATMENT FOR RETINOBLASTOMA |
| Estimated Enrollment: | 25 |
| Study Start Date: | February 1996 |
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.
Eligibility| Ages Eligible for Study: | up to 10 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Tennessee | |
| Saint Jude Children's Research Hospital | |
| Memphis, Tennessee, United States, 38105-2794 | |
| University of Tennessee, Memphis Cancer Center | |
| Memphis, Tennessee, United States, 38103 | |
| Study Chair: | Carlos Rodriguez-Galindo, MD | St. Jude Children's Research Hospital |
More Information
| Study ID Numbers: | CDR0000064874, SJCRH-RET-3, NCI-H96-0935 |
| Study First Received: | November 1, 1999 |
| Last Updated: | August 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00002794 History of Changes |
| Health Authority: | United States: Federal Government |
|
intraocular retinoblastoma |
|
Retinal Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Eye Neoplasms Antineoplastic Agents Eye Diseases Mitosis Modulators Neoplasms, Nerve Tissue Vincristine Antimitotic Agents Carboplatin Retinoblastoma |
Pharmacologic Actions Neuroectodermal Tumors Neoplasms Neoplasms by Site Therapeutic Uses Neoplasms, Germ Cell and Embryonal Tubulin Modulators Neoplasms, Neuroepithelial Antineoplastic Agents, Phytogenic Retinal Diseases Neoplasms, Glandular and Epithelial |
