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.
Who can participate
Age range
30 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
\>\>INCLUSION CRITERIA\<\<
DISEASE CHARACTERISTICS:
* Clinical diagnosis of bilateral intraocular retinoblastoma (RB)
* International Intraocular Retinoblastoma Classification (IIRC) Group B, C, or D disease in 1 or both eyes
* IIRC Group E disease in 1 eye allowed provided the eye was enucleated at diagnosis AND there is no extraocular RB in the enucleated eye by histologic confirmation AND there is IIRC Group B, C, or D disease in the remaining eye
PATIENT CHARACTERISTICS:
Age
* Over 30 days
Performance status
* Not specified
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* AST and ALT \< 2 times upper limit of normal (ULN)
* Conjugated and unconjugated bilirubin \< 2 times ULN
Renal
* Creatinine \< 1.5 times ULN
* Glomerular filtration rate (GFR) ≥ 100 mL/min\* NOTE: \*A 4-hour IV hydration is allowed if GFR is low due to poor hydration or transient dehydration
Other
* Meets 1 of the following auditory criteria:
* Normal audiogram
* At least normal responses to speech by audiogram
* Documentation of hearing by acoustic emission test
* Recording of evoked potentials by auditory brain stem response
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* See Disease Characteristics
\>\>EXCLUSION CRITERIA\<\<
* IIRC Group A disease in 1 or both eyes
* unilateral RB
* extraocular or metastatic RB
* younger t…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Comparing efficacy of study treatment with historic world data, in terms of increasing the proportion of eyes that remains relapse-free while avoiding external beam radiation and/or enucleation