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Clinical Trial Details — Status: Withdrawn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Status Withdrawn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Status Withdrawn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


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
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