IRB Number:

07-007430

Trial Status:

Open for Enrollment

Phase: III

Why is this study being done?

Patients are being asked to take part in this study because they have unilateral retinoblastoma. Retinoblastoma is an eye cancer which affects young children and is found in the retinal layer of the eye (the back layer of the eye). Unilateral means the disease is in only one eye.


Why Is This Study Being Done?
The purpose of this study is to collect information about patients who have retinoblastoma in only one eye and have had the eye removed. Based on an exam of the eye that was removed, doctors will try to see if the patient is more likely (at high risk) to have the cancer come back. They also hope to find out whether or not chemotherapy keeps the cancer from coming back in patients who are high risk. Patients whose cancer has not spread to other parts of the body are called low risk. Low risk patients will only have surgery and will be carefully watched by the study doctor to see if the cancer spreads to other parts of the body. The research staff hope this information will help them to better treat retinoblastoma.

Who is Eligible to Participate in the Study?

-Age 0 to 6 years old
-Newly diagnosed with Unilateral Retinoblastoma and have had surgery to remove the eye

*More specific, detailed eligibility and/ or exclusion criteria are associated with this trial.

What is Involved With this Study?

The tumor from the eye that was removed will be looked at carefully under a microscope by several different doctors. If it looks like the tumor has spread to other parts of the eye or its nerves, the doctors may suggest that more treatment be given to the patient (chemotherapy). Chemotherapy treatment involves the use of three drugs called, Carboplatin, Vincristine and Etoposide. Children whose eyes may not have had the cancer spread to
different parts of the eye will be watched to make sure the cancer does not come back or spread into other parts of the body, but will not get chemotherapy. Approximately 90 percent of the children in this study will not require chemotherapy and will be observed only.

BEFORE BEGINNING THE STUDY
Patients will need to have the following exams, tests or procedures to find out if they can be in the study. These things are part of regular cancer care and may be done even if the patient does not join the study. If the patient has had some of the tests recently, they may not need to be repeated. This will be up to the study doctor. Patients may have:
- Physical exams
- Blood tests
- CT/MRI scans (to see if any cancer can be found outside the eye)

DURING THE STUDY
If the exams show that the patient can be in the study, and they choose to take part, then the patient will need the following tests and procedures. They are also part of regular cancer care, and will be performed whether the patient takes part in the study or not. Patients will have:
- Physical exams
- Blood tests

Patients will need other tests and procedures that are part of this study and also part of the standard follow-up care even if they are not taking part in the study. The frequency of these studies may be different in this study and also usually varies from institution to institution. These studies are:
- Eye exams under anesthesia (while asleep)
- Tumor Disease Evaluations ( CT/MRI scans to see if any cancer can be found outside the eye or whether it has come back)

Some of the tumor tissue, slides and blood already taken, will be sent to central review centers as part of COG quality control where eye pathologists around the country will be reviewing the slides and also will be sent to be stored for future research uses.

How long will the Study run?

Patients who are not getting chemotherapy will be watched to make sure that the disease does not come back and will also have follow-up exams for at least five years. If the doctors feel that the patient might benefit from chemotherapy they will get chemotherapy for six months. After the patient is done with the chemotherapy, the
study doctor will ask the patient to visit the office for follow-up exams for at least five years.

The researchers would like to keep track of the patient for at least 10 years after the study closes to new patients or for as long as the patient is willing to let the research staff. Keeping in touch with the patient and checking on how their health is every year for a while after the study closes helps researchers understand the long-term effects (anything that might happen years after the patient has completed treatment) of the study.

Sponsor(s): Children's Oncology Group (COG)

Study Activation/Registration Date: 02/29/2008

IRB Review and Approval Date: 01/31/2008

Study Type: Treatment/Observation

Projected Accrual: The plan is to have up to 600 patients participate from multiple medical centers.

Costs of Study:There may be standard patient care costs related to participating in a cancer research study.

Principal Investigator: Shakila P. Khan, MD

Who can I Contact for Additional Information on this Trial?

Complete Request Form for Cancer Clinical Trial Information at Mayo Clinic or
For more information about this study or other clinical trial options, please contact our Mayo Clinic Cancer Center Clinical Trials Referral Office.

• Patients living within the United States, call 507-538-7623, or e-mail cancerclinicaltrials@mayo.edu


• Patients living outside the United States may call our International Office at 507-284-8884, or e-mail intl.mcr@mayo.edu.

What is/are the Locations of this Clinical Trial?

• Rochester, MN

Last updated: 05/13/2008