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Intra-arterial Chemotherapy for Advanced Intraocular Retinoblastoma


Phase 2
N/A
18 Years
Not Enrolling
Both
Retinoblastoma, Eye Cancer

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Trial Information

Intra-arterial Chemotherapy for Advanced Intraocular Retinoblastoma


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response: Globe salvage rate (Eyes saved/Eyes treated). This will be determined by clinical ocular examination.

Outcome Time Frame:

Follow-up will be performed for one year from treatment date.

Safety Issue:

No

Principal Investigator

Jonathan W Kim

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Institutional Review Board

Study ID:

PEDSEYE0001

NCT ID:

NCT01151748

Start Date:

September 2010

Completion Date:

March 2012

Related Keywords:

  • Retinoblastoma
  • Eye Cancer
  • Eye Neoplasms
  • Retinoblastoma

Name

Location
Stanford University School of Medicine Stanford, California  94305-5317