Intra-arterial Chemotherapy for Advanced Intraocular Retinoblastoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01151748
Recruitment Status : Withdrawn (Study abandoned; Could not obtain final SRC approval due to IND disagreements)
First Posted : June 28, 2010
Last Update Posted : May 14, 2012
Information provided by (Responsible Party):
Stanford University

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 Type : Interventional  (Clinical Trial)
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 : September 2010
Estimated Primary Completion Date : March 2011
Estimated Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01151748

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

Responsible Party: Stanford University Identifier: NCT01151748     History of Changes
Other Study ID Numbers: PEDSEYE0001
SU-07072009-3000 ( Other Identifier: Stanford University )
First Posted: June 28, 2010    Key Record Dates
Last Update Posted: May 14, 2012
Last Verified: May 2012

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