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Carboplatin Plus Vincristine in Treating Children With Retinoblastoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002794
First Posted: April 26, 2004
Last Update Posted: October 4, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
St. Jude Children's Research Hospital
  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 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Evaluation of Chemotherapy as Initial Treatment for Retinoblastoma

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Enrollment: 25
Study Start Date: February 1996
Study Completion Date: June 2001
Primary Completion Date: June 2001 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002794


Locations
United States, Tennessee
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, United States, 38103
Saint Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105-2794
Sponsors and Collaborators
St. Jude Children's Research Hospital
National Cancer Institute (NCI)
Investigators
Study Chair: Carlos Rodriguez-Galindo, MD St. Jude Children's Research Hospital
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00002794     History of Changes
Other Study ID Numbers: CDR0000064874
P30CA021765 ( U.S. NIH Grant/Contract )
P01CA023099 ( U.S. NIH Grant/Contract )
SJCRH: RET3
NCI-H96-0935
First Submitted: November 1, 1999
First Posted: April 26, 2004
Last Update Posted: October 4, 2011
Last Verified: October 2011

Keywords provided by St. Jude Children's Research Hospital:
intraocular retinoblastoma

Additional relevant MeSH terms:
Retinoblastoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Retinal Neoplasms
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Retinal Diseases
Carboplatin
Vincristine
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action


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