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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00072384 |
RATIONALE: Drugs used in chemotherapy, such as vincristine, carboplatin, and etoposide, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether systemic chemotherapy and subtenon (under the conjunctiva of the eye) carboplatin combined with ophthalmic therapy is effective in treating intraocular (within the eyeball) retinoblastoma.
PURPOSE: Phase III trial to determine the effectiveness of combining systemic chemotherapy and subtenon carboplatin with ophthalmic therapy in treating children who have intraocular retinoblastoma.
Condition | Intervention | Phase |
---|---|---|
Retinoblastoma |
Drug: carboplatin Drug: etoposide Drug: filgrastim Drug: vincristine sulfate Procedure: cryosurgery Procedure: laser surgery |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Single Arm Trial of Systemic And Subtenon Chemotherapy For Groups C And D Intraocular Retinoblastoma |
Estimated Enrollment: | 69 |
Study Start Date: | April 2007 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive vincristine IV over 1 minute on day 1 and carboplatin IV over 1 hour and etoposide IV over 1 hour on days 1 and 2. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on day 3 and continuing until blood counts recover. Patients receive subtenon carboplatin to each group C or D eye on day 0 of courses 2-4 only. Treatment repeats every 28 days for 6 courses in the absence of occurrence of extraocular retinoblastoma or a second malignancy. Beginning with course 3 of systemic chemotherapy, patients undergo local ophthalmic therapy comprising local laser and/or cryotherapy on day 1.
Patients are followed with ophthalmology exams every 4-12 weeks until 3 years of age, every 6 months until 5 years of age, and then annually for up to 10 years.
PROJECTED ACCRUAL: A total of 69 patients will be accrued for this study within 3 years.
Ages Eligible for Study: | up to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of bilateral retinoblastoma with at least 1 eye group C or D intraocular retinoblastoma by ophthalmologic examination, defined by the International Classification System for Intraocular Retinoblastoma as the following:
Group C: Discrete localized disease with minimal subretinal and/or vitreous seeding
Group D: Diffuse disease with significant vitreous and/or subretinal seeding
No tumor present on histologic examination at the cut end of the optic nerve on any eye enucleated prior to study entry
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Creatinine adjusted according to age as follows:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, California | |
Childrens Hospital Los Angeles | Recruiting |
Los Angeles, California, United States, 90027 | |
Contact: Leo Mascarenhas 323-361-2529 | |
United States, Florida | |
University of Miami Sylvester Comprehensive Cancer Center - Miami | Recruiting |
Miami, Florida, United States, 33136 | |
Contact: University of Miami Sylvester Comprehensive Cancer Center Clin 866-574-5124 Sylvester@emergingmed.com | |
United States, Georgia | |
Winship Cancer Institute of Emory University | Recruiting |
Atlanta, Georgia, United States, 30322 | |
Contact: Howard M. Katzenstein 404-785-0853 | |
United States, Illinois | |
Children's Memorial Hospital - Chicago | Recruiting |
Chicago, Illinois, United States, 60614 | |
Contact: David O. Walterhouse 773-755-6514 | |
University of Illinois Cancer Center | Recruiting |
Chicago, Illinois, United States, 60612-7243 | |
Contact: Clinical Trial Office - University of Illinois Cancer Center 312-355-3046 | |
United States, North Carolina | |
Duke Comprehensive Cancer Center | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: Clinical Trials Office - Duke Comprehensive Cancer Center 888-275-3853 | |
United States, Ohio | |
Cincinnati Children's Hospital Medical Center | Recruiting |
Cincinnati, Ohio, United States, 45229-3039 | |
Contact: Clinical Trials Office - Cincinnati Children's Hospital Medica 513-636-0161 | |
United States, Texas | |
Baylor University Medical Center - Houston | Recruiting |
Houston, Texas, United States, 77030-2399 | |
Contact: Alberto Pappo 832-822-4248 | |
M. D. Anderson Cancer Center at University of Texas | Recruiting |
Houston, Texas, United States, 77030-4009 | |
Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U 713-792-3245 | |
United States, Washington | |
Children's Hospital and Regional Medical Center - Seattle | Recruiting |
Seattle, Washington, United States, 98105 | |
Contact: Douglas Hawkins 206-987-3096 |
Study Chair: | Rima Jubran, MD | Children's Hospital Los Angeles |
Investigator: | Timothy G. Murray, MD | Sylvester Cancer Center |
Study ID Numbers: | CDR0000339627, COG-ARET0231 |
Study First Received: | November 4, 2003 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00072384 |
Health Authority: | Unspecified |
intraocular retinoblastoma |
Retinal Neoplasms Eye Neoplasms Eye Diseases Vincristine Carboplatin Retinoblastoma Etoposide phosphate |
Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neuroepithelioma Etoposide Retinal Diseases Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Mitosis Modulators Antimitotic Agents Pharmacologic Actions |
Neoplasms Neoplasms by Site Therapeutic Uses Tubulin Modulators Neoplasms, Neuroepithelial Antineoplastic Agents, Phytogenic |