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

NCT ID: NCT00857519

Last Updated: 2016-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2014-04-30

Brief Summary

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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

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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.

Conditions

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Retinoblastoma

Keywords

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retinoblastoma Intraarterial Chemotherapy Melphalan Carboplatin

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Chemotherapy

Chemotherapy using Melphalan, Carboplatin.

Group Type EXPERIMENTAL

Melphalan, Carboplatin

Intervention Type DRUG

Intra-arterial chemotherapy.

Interventions

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Melphalan, Carboplatin

Intra-arterial chemotherapy.

Intervention Type DRUG

Other Intervention Names

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ALKERAN,PARAPLATIN

Eligibility Criteria

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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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Thomas Jefferson University

OTHER

Sponsor Role collaborator

Wills Eye

OTHER

Sponsor Role lead

Responsible Party

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Carol L Shields

Carol L. Shields, MD Co-Director, Ocular Onology Service

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carol L Shields, MD

Role: PRINCIPAL_INVESTIGATOR

Oncology Service, Wills Eye Institute

Locations

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Oncology Service, Wills Eye Institute

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 26469234 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24407202 (View on PubMed)

Other Identifiers

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08-885

Identifier Type: -

Identifier Source: org_study_id