CClinicalTrials.gg
CompletedNCT00857519IAC-RBUpdated Dec 12, 2016

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

An interventional study of Melphalan, Carboplatin in Retinoblastoma, sponsored by Wills Eye. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2016-12-12.

Sponsored by Wills Eye · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Retinoblastoma

Browse trials for

Keywords

  • retinoblastoma
  • Intraarterial
  • Chemotherapy
  • Melphalan
  • Carboplatin
03

In context

Retinoblastoma

124 studies on the registry are indexed under Retinoblastoma; 23 are open to participants now.

This study's enrollment of 10 is below the median of 29 across 78 interventional studies indexed under Retinoblastoma.

Browse Retinoblastoma studies →

Lead sponsor

Wills Eye is the lead sponsor of 74 studies on the registry; 3 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 10 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Chemotherapy

    Chemotherapy using Melphalan, Carboplatin.

    Drug: Melphalan, Carboplatin

Interventions

  • DrugMelphalan, Carboplatin

    Intra-arterial chemotherapy.

    Also known as: ALKERAN,PARAPLATIN

06

What researchers measure

Primary outcomes

  1. Tumor control

    Time frame: after 5 cycles of chemotherapy

07

Study locations

1 site
  • Oncology Service, Wills Eye Institute
    Philadelphia, Pennsylvania 19107, United States
08

References and documents

Publications

  • 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. PubMed 26469234 ↗
  • 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. PubMed 24407202 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00857519
Lead sponsor
Wills Eye
Collaborators
Thomas Jefferson University
Responsible party
Carol L Shields (Carol L. Shields, MD Co-Director, Ocular Onology Service, Wills Eye) — Principal investigator
First posted
Mar 6, 2009
Start date
Jan 2009
Primary completion
Mar 2014
Completion
Apr 2014
Last update
Dec 12, 2016

Study contacts

Carol L Shields, MD
principal investigator · Oncology Service, Wills Eye Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion