Intra-arterial Chemotherapy for Advanced Intraocular Retinoblastoma

Phase 2

Withdrawn

• Conditions: Eye Cancer; Retinoblastoma

• Registration Number: NCT01151748
• Lead Sponsor: Stanford University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-03-04
• Study First Submitted QC: 2010-06-25
• Study First Posted: 2010-06-28
• Study Start: 2010-09
• Primary Completion: 2011-03
• Study Completion: 2012-03
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-10
• Last Update Posted: 2012-05-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States