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Intra-arterial Chemotherapy for Advanced Intraocular Retinoblastoma

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ClinicalTrials.gov 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Recruitment Status : Withdrawn (Study abandoned; Could not obtain final SRC approval due to IND disagreements)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
Sponsor:
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

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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. ]


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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.

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

Responsible Party: Stanford University
ClinicalTrials.gov 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:
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