NCT00857519

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2009

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

December 12, 2016

Status Verified

December 1, 2016

Enrollment Period

5.2 years

First QC Date

March 4, 2009

Last Update Submit

December 9, 2016

Conditions

Retinoblastoma

Keywords

retinoblastomaIntraarterialChemotherapyMelphalanCarboplatin

Outcome Measures

Primary Outcomes (1)

  • Tumor control

    after 5 cycles of chemotherapy

Study Arms (1)

Chemotherapy

EXPERIMENTAL

Chemotherapy using Melphalan, Carboplatin.

Drug: Melphalan, Carboplatin

Interventions

Melphalan, CarboplatinDRUG

Intra-arterial chemotherapy.

Also known as: ALKERAN,PARAPLATIN
Chemotherapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oncology Service, Wills Eye Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (2)

  • 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.

    PMID: 26469234BACKGROUND

  • 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.

    PMID: 24407202BACKGROUND

MeSH Terms

Conditions

Retinoblastoma

Interventions

MelphalanCarboplatin

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueRetinal NeoplasmsEye NeoplasmsNeoplasms by SiteEye Diseases, HereditaryEye DiseasesRetinal Diseases

Intervention Hierarchy (Ancestors)

Nitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsCoordination Complexes

Study Officials

  • Carol L Shields, MD

    Oncology Service, Wills Eye Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Carol L. Shields, MD Co-Director, Ocular Onology Service

Study Record Dates

First Submitted

March 4, 2009

First Posted

March 6, 2009

Study Start

January 1, 2009

Primary Completion

March 1, 2014

Study Completion

April 1, 2014

Last Updated

December 12, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)