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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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT01151748
First Posted: June 28, 2010
Last Update Posted: May 14, 2012
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.
Information provided by (Responsible Party):
Stanford University
  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
Intervention Model: Single Group Assignment
Masking: None (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. ]

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

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
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
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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01151748     History of Changes
Other Study ID Numbers: PEDSEYE0001
SU-07072009-3000 ( Other Identifier: Stanford University )
First Submitted: March 4, 2010
First Posted: June 28, 2010
Last Update Posted: May 14, 2012
Last Verified: May 2012

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