Intra-arterial Chemotherapy for Advanced Intraocular Retinoblastoma

Retinoblastoma Clinical Trial

Official title:

Intra-arterial Chemotherapy for Advanced Intraocular Retinoblastoma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01151748
• Other study ID #: PEDSEYE0001
• Secondary ID: SU-07072009-3000
• Status: Withdrawn
• Phase: Phase 2
• First received: March 4, 2010
• Last updated: May 10, 2012
• Start date: September 2010
• Est. completion date: March 2012

Study information

• Verified date: May 2012
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Phase II study of selective intra-arterial infusion of chemotherapy for intraocular retinoblastoma

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2012
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

1. Patients diagnosed with advanced intraocular retinoblastoma (International Retinoblastoma Classification group D or E*).

2. Patients with tumor recurrence or vitreous seeding following completion of systemic chemotherapy or previous radiation therapy.

Exclusion Criteria:

1. Congenital brain anomaly identified on MRI.

2. History of systemic coagulopathy.

3. Evidence of extra ocular retinoblastoma on clinical examination or neuroimaging.

Study Design

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

Related Conditions & MeSH terms

• Eye Cancer
• Retinoblastoma

Intervention

Procedure:
• Intra-arterial infusion of chemotherapy

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response: Globe salvage rate (Eyes saved/Eyes treated). This will be determined by clinical ocular examination.		Follow-up will be performed for one year from treatment date.	No