Retinoblastoma Clinical Trial
— IAC-RBOfficial title:
Intra-arterial (Ophthalmic Artery) Chemotherapy for Retinoblastoma
Verified date | December 2016 |
Source | Wills Eye |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | April 2014 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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) |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Oncology Service, Wills Eye Institute | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Wills Eye | Thomas Jefferson University |
United States,
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. — View Citation
Tuncer S, Balci Ö, Tanyildiz B, Kebudi R, Shields CL. Intravitreal Lower-Dose (20 µg) 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tumor control | after 5 cycles of chemotherapy | Yes |
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