RetinoblastomaIAC-RBNCT00857519
A Study of the Effectiveness of a Local Injection of Chemotherapy for Retinoblastoma
A study testing Melphalan, Carboplatin in people with Retinoblastoma, run by Wills Eye at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Retinoblastoma
- What is being tested?
- Melphalan, Carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Oncology Service, Wills Eye Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: Intra-arterial (Ophthalmic Artery) Chemotherapy for Retinoblastoma
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.
- Conditions
- Retinoblastoma
- Being tested
- Melphalan, Carboplatin
- Keywords
- retinoblastoma, Intraarterial, Chemotherapy, Melphalan, Carboplatin
- Medical subject headings
- Retinoblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melphalan, CarboplatinDrug
Also called ALKERAN,PARAPLATIN
Intra-arterial chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy | Experimental | Chemotherapy using Melphalan, Carboplatin. Receives: Drug: Melphalan, Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor control
Measured: after 5 cycles of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2009 (estimated)
- Study startJan 2009
- Primary completionMar 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for RetinoblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wills Eye
- Sponsor type
- University, hospital or other
- Collaborators
- Thomas Jefferson University
- Responsible party
- Principal investigator, Carol L Shields, Wills Eye
- Investigators
- Carol L Shields, MD, Principal investigator, Oncology Service, Wills Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00857519
- Sponsor's protocol ID
- 08-885
- Acronym
- IAC-RB
- Status last verified
- Dec 2016
- First submitted
- 4 Mar 2009
- Last updated
- 12 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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 26469234Shields 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-arterial (Ophthalmic Artery) Chemotherapy for Retinoblastoma
- ClinicalTrials.gov ID
- NCT00857519
- Acronym / sponsor ID
- IAC-RB / 08-885
- Conditions
- Retinoblastoma
- Keywords
- retinoblastoma, Intraarterial, Chemotherapy, Melphalan, Carboplatin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Wills EyeUniversity, hospital or other
- Collaborators
- Thomas Jefferson University
- Study start
- Jan 2009
- Primary completion
- Mar 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 6 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy | Experimental | Drug: Melphalan, CarboplatinChemotherapy using Melphalan, Carboplatin. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melphalan, CarboplatinAlso: ALKERAN,PARAPLATINIntra-arterial chemotherapy. | Drug | Chemotherapy |
Primary outcome
Tumor control
Time frame: after 5 cycles of chemotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2016.
- Background: PubMed 26469234Tuncer 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.
- Background: PubMed 24407202Shields 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carol L Shields, MD principal investigator
Oncology Service, Wills Eye Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melphalan, Carboplatin in people with Retinoblastoma, run by Wills Eye at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor control (time frame: after 5 cycles of chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00857519, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2016.