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ACTIVE NOT RECRUITING
NCT00110110
PHASE2

Combination Chemotherapy and Cyclosporine Followed by Focal Therapy for Bilateral Retinoblastoma

Sponsor: The Hospital for Sick Children

View on ClinicalTrials.gov

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

BIOLOGICAL

filgrastim

Given after chemo cycle for 7 days or until neutrophil counts return to normal.

DRUG

Carboplatin

Given at 28 mg/kg/dose.

DRUG

Cyclosporine

Given at 33 mg/kg/dose

DRUG

Etoposide

Given at 12 mg/kg/dose

DRUG

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

PROCEDURE

cryosurgery

Local application of extreme cold to destroy residual tumor.

PROCEDURE

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