A Study of the Effectiveness of a Local Injection of Chemotherapy for Retinoblastoma (IAC-RB)
Primary Purpose
Retinoblastoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Melphalan, Carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for Retinoblastoma focused on measuring retinoblastoma, Intraarterial, Chemotherapy, Melphalan, Carboplatin
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)
Sites / Locations
- Oncology Service, Wills Eye Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Chemotherapy
Arm Description
Chemotherapy using Melphalan, Carboplatin.
Outcomes
Primary Outcome Measures
Tumor control
Secondary Outcome Measures
Full Information
NCT ID
NCT00857519
First Posted
March 4, 2009
Last Updated
December 9, 2016
Sponsor
Wills Eye
Collaborators
Thomas Jefferson University
1. Study Identification
Unique Protocol Identification Number
NCT00857519
Brief Title
A Study of the Effectiveness of a Local Injection of Chemotherapy for Retinoblastoma
Acronym
IAC-RB
Official Title
Intra-arterial (Ophthalmic Artery) Chemotherapy for Retinoblastoma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wills Eye
Collaborators
Thomas Jefferson University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinoblastoma
Keywords
retinoblastoma, Intraarterial, Chemotherapy, Melphalan, Carboplatin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chemotherapy
Arm Type
Experimental
Arm Description
Chemotherapy using Melphalan, Carboplatin.
Intervention Type
Drug
Intervention Name(s)
Melphalan, Carboplatin
Other Intervention Name(s)
ALKERAN,PARAPLATIN
Intervention Description
Intra-arterial chemotherapy.
Primary Outcome Measure Information:
Title
Tumor control
Time Frame
after 5 cycles of chemotherapy
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol L Shields, MD
Organizational Affiliation
Oncology Service, Wills Eye Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oncology Service, Wills Eye Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26469234
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.
Results Reference
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PubMed Identifier
24407202
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.
Results Reference
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A Study of the Effectiveness of a Local Injection of Chemotherapy for Retinoblastoma
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