Intra-arterial Chemotherapy for Advanced Intraocular Retinoblastoma

This study has been withdrawn prior to enrollment.
(Study abandoned; Could not obtain final SRC approval due to IND disagreements)
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01151748
First received: March 4, 2010
Last updated: May 10, 2012
Last verified: May 2012
  Purpose

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


Condition Intervention Phase
Retinoblastoma
Eye Cancer
Procedure: Intra-arterial infusion of chemotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intra-arterial Chemotherapy for Advanced Intraocular Retinoblastoma

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: September 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01151748

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Jonathan W Kim Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01151748     History of Changes
Other Study ID Numbers: PEDSEYE0001, SU-07072009-3000
Study First Received: March 4, 2010
Last Updated: May 10, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Eye Neoplasms
Retinoblastoma
Neoplasms by Site
Neoplasms
Eye Diseases
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Retinal Neoplasms
Retinal Diseases

ClinicalTrials.gov processed this record on April 15, 2014