A Study of the Effectiveness of a Local Injection of Chemotherapy for Retinoblastoma

Study Overview
=================
Brief Summary
-----------------
Over the past 15 years, intravenous chemotherapy has become the most popular conservative (eye-saving) method for retinoblastoma treatment because it is often effective and usually safe. In recent years, there has been much interest in providing highly focused (focal) chemotherapy to a diseased organ including the liver, brain, and eye. With focused chemotherapy, the chemotherapy drugs are injected directly into the ophthalmic artery (the artery that supplies blood to the eye). A benefit of focal chemotherapy delivery is that it decreases the chance of toxicity to other organs such as bone marrow suppression (causing low blood counts) and the development of other cancers in the future.

Detailed Description
-----------------
The management of retinoblastoma includes systemic chemotherapy (carboplatin, etoposide, and vincristine), thermotherapy, cryotherapy (freezing treatment), laser photocoagulation, plaque radiotherapy, external beam radiotherapy, and enucleation. The treatment is tailored to each individual case. Over the past 15 years, intravenous chemotherapy has risen as the most popular conservative (eye-saving) method for retinoblastoma management because it is effective and safe. In recent years, there has been keen interest in providing chemotherapy more focally to a diseased organ including the liver, brain, and eye. The benefit of focal chemotherapy delivery is to avoid toxicity to other organs and this toxicity includes the risk of future cancers.

Official Title
-----------------
Intra-arterial (Ophthalmic Artery) Chemotherapy for Retinoblastoma

Conditions
-----------------
Retinoblastoma

Intervention / Treatment
-----------------
* Drug: Melphalan, Carboplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced retinoblastoma in one or both eyes Recurrent retinoblastoma after failure of previous treatment No age limit (usually kids presenting with retinoblastoma present in the 1st two decades of life) Judged by principal investigator to be medically and physically able to undergo the procedure Exclusion Criteria: Recurrent retinoblastoma which is treatable with other conservative measures Invasive retinoblastoma (retinoblastoma that has grown locally outside of the eye, for example, into the bone around the eye)
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chemotherapy<br>Chemotherapy using Melphalan, Carboplatin. | Drug: Melphalan, Carboplatin<br>* Intra-arterial chemotherapy.<br>* Other names: ALKERAN,PARAPLATIN;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor control |  | after 5 cycles of chemotherapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
retinoblastoma, Intraarterial, Chemotherapy, Melphalan, Carboplatin