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

Retinoblastoma Clinical Trial

— IAC-RB  

Official title:

Intra-arterial (Ophthalmic Artery) Chemotherapy for Retinoblastoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00857519
• Other study ID #: 08-885
• Status: Completed
• Phase: N/A
• First received: March 4, 2009
• Last updated: December 9, 2016
• Start date: January 2009
• Est. completion date: April 2014

Study information

• 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

Clinical 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. 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.

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.

Recruitment information / eligibility

• 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)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Retinoblastoma

Intervention

Drug:
• Melphalan, Carboplatin
Intra-arterial chemotherapy.

Locations

Country	Name	City	State
United States	Oncology Service, Wills Eye Institute	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Wills Eye	Thomas Jefferson University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor control		after 5 cycles of chemotherapy	Yes