Spots Global Cancer Trial Database for Neoadjuvant Carboplatin and Vincristine and Standard Local Ophthalmic Therapy in Treating Patients With Intraocular Retinoblastoma
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Trial Identification
Brief Title: Neoadjuvant Carboplatin and Vincristine and Standard Local Ophthalmic Therapy in Treating Patients With Intraocular Retinoblastoma
Official Title: Trial of Systemic Neoadjuvant Chemotherapy for Group B Intraocular Retinoblastoma
Study ID: NCT00079417
Conditions
Study Description
Brief Summary: This phase III trial is studying how well giving carboplatin and vincristine together with standard local ophthalmic therapy works in treating children with intraocular retinoblastoma. Drugs used in chemotherapy, such as carboplatin and vincristine, work in different ways to stop tumor from dividing so they stop growing or die. It is not yet known whether neoadjuvant chemotherapy combined with standard local ophthalmic therapy is effective in treating intraocular retinoblastoma.
Detailed Description: PRIMARY OBJECTIVES: I. Determine the 2-year event-free survival of patients with Group B intraocular retinoblastoma treated with neoadjuvant chemoreduction comprising carboplatin and vincristine and standardized local ophthalmic therapy. SECONDARY OBJECTIVES: I. Determine the response rate after one course of chemoreduction (before standardized local ophthalmic therapy) in these patients. II. Correlate response rate with event-free survival in patients treated with this regimen. III. Determine the incidence of toxic effects in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive chemoreduction comprising carboplatin IV over 60 minutes followed by vincristine IV over 1-2 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the first course of chemoreduction, patients undergo standardized local ophthalmic therapy comprising local laser therapy, cryotherapy, and/or radioactive plaque comprising iodine I 125 or ruthenium Ru 106. Patients are followed every 3-4 weeks until there is no active tumor seen on a minimum of 3 ophthalmic exams under anesthesia, every 6-8 weeks until 3 years of age, every 4-6 months until 10 years of age, and then annually thereafter.
Keywords
Eligibility
Minimum Age:
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
Locations
Children's Hospital Los Angeles, Los Angeles, California, United States
Lurie Children's Hospital-Chicago, Chicago, Illinois, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States
Duke University Medical Center, Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
Children's Oncology Group, Philadelphia, Pennsylvania, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center, Houston, Texas, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Contact Details
Name: Debra L Friedman
Affiliation: Children's Oncology Group
Role: PRINCIPAL_INVESTIGATOR
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