Clinical trial NCT00857519: A Study of the Effectiveness of a Local Injection of Chemotherapy for Retinoblastoma
Official title: Intra-arterial (Ophthalmic Artery) Chemotherapy for Retinoblastoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinoblastoma
Keywords: retinoblastoma
Intraarterial
Chemotherapy
Melphalan
Carboplatin
Lead sponsor: Wills Eye
Sponsor class: OTHER
Collaborators: name: Thomas Jefferson University
First posted: 2009-03-06
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Tumor control
timeFrame: after 5 cycles of chemotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Oncology Service, Wills Eye Institute
state: Pennsylvania
Study officials:
affiliation: Oncology Service, Wills Eye Institute
name: Carol L Shields, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tuncer S, Balci O, Tanyildiz B, Kebudi R, Shields CL. Intravitreal Lower-Dose (20 microg) Melphalan for Persistent or Recurrent Retinoblastoma Vitreous Seeds. Ophthalmic Surg Lasers Imaging Retina. 2015 Oct;46(9):942-8. doi: 10.3928/23258160-20151008-07.
citation: Shields CL, Manjandavida FP, Arepalli S, Kaliki S, Lally SE, Shields JA. Intravitreal melphalan for persistent or recurrent retinoblastoma vitreous seeds: preliminary results. JAMA Ophthalmol. 2014 Mar;132(3):319-25. doi: 10.1001/jamaophthalmol.2013.7666.