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Combination Chemotherapy and Cyclosporine Followed by Focal Therapy for Bilateral Retinoblastoma
Sponsor: The Hospital for Sick Children
Summary
RATIONALE: Drugs used in chemotherapy, such as carboplatin, etoposide, and vincristine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sometimes when chemotherapy is given, it does not stop the growth of tumor cells. The tumor is said to be resistant to chemotherapy. Giving cyclosporine together with chemotherapy may reduce drug resistance and allow the tumor cells to be killed. Cryotherapy kills tumor cells by freezing them. Laser therapy uses light to kill tumor cells. Giving combination chemotherapy together with cyclosporine followed by cryotherapy and/or laser therapy may be an effective treatment for retinoblastoma. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with cyclosporine followed by cryotherapy and/or laser therapy works in treating patients with newly diagnosed retinoblastoma in both eyes.
Official title: Multicenter Phase II Study for International Intraocular Retinoblastoma Classification Groups B, C & D Tumors Treated With Carboplatin-Etoposide-Vincristine-Cyclosporine-Focal Therapy Multimodality Protocol (OCRN Multicenter RB 2003)
Key Details
Gender
All
Age Range
30 Days - Any
Study Type
INTERVENTIONAL
Enrollment
71
Start Date
2004-06
Completion Date
2024-12-31
Last Updated
2024-04-17
Healthy Volunteers
No
Conditions
Interventions
filgrastim
Given after chemo cycle for 7 days or until neutrophil counts return to normal.
Carboplatin
Given at 28 mg/kg/dose.
Cyclosporine
Given at 33 mg/kg/dose
Etoposide
Given at 12 mg/kg/dose
vincristine sulfate
Given at 0.025 mg/kg/dose for the first cycle and 0.05 mg/kg/dose for subsequent cycles if first cycle well-tolerated
cryosurgery
Local application of extreme cold to destroy residual tumor.
laser therapy
Local and precise application of laser beams to destroy residual tumor.
Locations (6)
Children's and Women's Hospital of British Columbia
Vancouver, British Columbia, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
Montreal Children's Hospital at McGill University Health Center
Montreal, Quebec, Canada
Hospital San Juan de Dios
Santiago, Chile
Sankara Nethralaya Super Specialty Clinic
Chennai, India
Kandang Kerbau Women's and Children's Hospital
Singapore, Singapore