Intra-arterial Chemotherapy for Advanced Intraocular Retinoblastoma

• Sponsor: Stanford University (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT01151748
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Duration (Months): 18
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Retinoblastoma; Eye Cancer	Procedure: Intra-arterial infusion of chemotherapy	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Intra-arterial Chemotherapy for Advanced Intraocular Retinoblastoma
• Study Start Date: Sep 1, 2010
• Anticipated Primary Completion Date: Mar 1, 2011
• Anticipated Study Completion Date: Mar 1, 2012

Outcome Measures

Primary Outcome Measures

1. 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.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University School of Medicine	Stanford	California	United States	94305

Sponsors and Collaborators

• Stanford University

Investigators

• Principal Investigator: Jonathan W Kim, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stanford University
• ClinicalTrials.gov Identifier: NCT01151748
• Other Study ID Numbers: PEDSEYE0001; SU-07072009-3000
• First Posted: Jun 28, 2010
• Last Update Posted: May 14, 2012
• Last Verified: May 1, 2012

• Additional relevant MeSH terms: Retinoblastoma; Eye Neoplasms

Study Results

No Results Posted as of May 14, 2012