Back to resultsIntra-arterial Chemotherapy for Advanced Intraocular Retinoblastoma
Primary Purpose
Retinoblastoma, Eye Cancer
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Intra-arterial infusion of chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Retinoblastoma
Eligibility Criteria
Inclusion Criteria:
- Patients diagnosed with advanced intraocular retinoblastoma (International Retinoblastoma Classification group D or E*).
- Patients with tumor recurrence or vitreous seeding following completion of systemic chemotherapy or previous radiation therapy.
Exclusion Criteria:
- Congenital brain anomaly identified on MRI.
- History of systemic coagulopathy.
- Evidence of extra ocular retinoblastoma on clinical examination or neuroimaging.
Sites / Locations
- Stanford University School of Medicine
Outcomes
Primary Outcome Measures
Response: Globe salvage rate (Eyes saved/Eyes treated). This will be determined by clinical ocular examination.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01151748
Brief Title
Intra-arterial Chemotherapy for Advanced Intraocular Retinoblastoma
Official Title
Intra-arterial Chemotherapy for Advanced Intraocular Retinoblastoma
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Study abandoned; Could not obtain final SRC approval due to IND disagreements
Study Start Date
September 2010 (undefined)
Primary Completion Date
March 2011 (Anticipated)
Study Completion Date
March 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
4. Oversight
5. Study Description
Brief Summary
Phase II study of selective intra-arterial infusion of chemotherapy for intraocular retinoblastoma
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinoblastoma, Eye Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Intra-arterial infusion of chemotherapy
Primary Outcome Measure Information:
Title
Response: Globe salvage rate (Eyes saved/Eyes treated). This will be determined by clinical ocular examination.
Time Frame
Follow-up will be performed for one year from treatment date.
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients diagnosed with advanced intraocular retinoblastoma (International Retinoblastoma Classification group D or E*).
Patients with tumor recurrence or vitreous seeding following completion of systemic chemotherapy or previous radiation therapy.
Exclusion Criteria:
Congenital brain anomaly identified on MRI.
History of systemic coagulopathy.
Evidence of extra ocular retinoblastoma on clinical examination or neuroimaging.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan W Kim
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Intra-arterial Chemotherapy for Advanced Intraocular Retinoblastoma
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