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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase III Study of Systemic Chemotherapy Comprising Vincristine, Carboplatin, and Etoposide, Subtenon Carboplatin, and Local Ophthalmic Therapy in Pediatric Patients With Group C or D Intraocular Retinoblastoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Active	Under 18	NCI	COG-ARET0231 ARET0231, NCT00072384

Trial Description

Purpose:

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.

Phase III trial to determine the effectiveness of combining systemic chemotherapy and subtenon carboplatin with ophthalmic therapy in treating children who have intraocular retinoblastoma.

Eligibility:

Eligibility criteria include the following:

• Younger than 18 years old
• Retinoblastoma in both eyes
• No retinoblastoma that has spread beyond the eye
• No previous chemotherapy or radiation therapy
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will receive an infusion of vincristine on day 1 and 1-hour infusions of carboplatin and etoposide on days 1 and 2. Beginning on day 3, they will receive an injection of filgrastim once a day until blood counts return to normal. Treatment may be repeated every 4 weeks for up to six courses. One day before beginning courses two, three, and four, patients will also receive an injection of carboplatin into the space below the conjuctiva of the eye. Beginning with course three, patients will also undergo laser therapy and/or cryotherapy to the eyes on day 1.

Patients will be evaluated periodically until they are 5 years old and once a year for up to 10 years.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Children's Oncology Group

Rima Jubran, MD, Protocol chair		Ph: 323-669-5639 Email: rjubran@chla.usc.edu
Timothy Murray, MD, Protocol co-chair		Ph: 305-326-6000

U.S.A.
California
	Los Angeles
	Childrens Hospital Los Angeles
		Leo Mascarenhas	Ph:  323-361-2529
Florida
	Miami
	University of Miami Sylvester Comprehensive Cancer Center - Miami
		University of Miami Sylvester Comprehensive Cancer Center Clinical Trial Matching Service	Ph:  866-574-5124
			Email: Sylvester@emergingmed.com
Georgia
	Atlanta
	Winship Cancer Institute of Emory University
		Howard Katzenstein	Ph:  404-785-0853
Illinois
	Chicago
	Children's Memorial Hospital - Chicago
		Stewart Goldman	Ph:  773-880-3270
	University of Illinois Cancer Center
		Clinical Trial Office - University of Illinois Cancer Center	Ph:  312-355-3046
North Carolina
	Durham
	Duke Comprehensive Cancer Center
		Clinical Trials Office - Duke Comprehensive Cancer Center	Ph:  888-275-3853
Ohio
	Cincinnati
	Cincinnati Children's Hospital Medical Center
		Clinical Trials Office - Cincinnati Children's Hospital Medical Center	Ph:  513-636-2799
Texas
	Houston
	Baylor University Medical Center - Houston
		Patrick Thompson	Ph:  832-824-4029
	M. D. Anderson Cancer Center at University of Texas
		Clinical Trials Office - M. D. Anderson Cancer Center at the University of Texas	Ph:  713-792-3245
Washington
	Seattle
	Children's Hospital and Regional Medical Center - Seattle
		Julie Park	Ph:  206-987-2106

Registry Information
Official Title		A Single Arm Trial of Systemic And Subtenon Chemotherapy For Groups C And D Intraocular Retinoblastoma
Trial Start Date		2007-04-16
Trial Completion Date		2010-02-14 (estimated)
Registered in ClinicalTrials.gov		NCT00072384
Date Submitted to PDQ		2003-09-30
Information Last Verified		2009-11-25
NCI Grant/Contract Number		CA98543

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