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Intra-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Withdrawn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
Stanford University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinoblastoma

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

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

First Posted
March 4, 2010
Last Updated
May 10, 2012
Sponsor
Stanford University
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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Withdrawn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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