Intra-arterial Chemotherapy for the Treatment of Intraocular Retinoblastoma
NCT ID: NCT01293539
Last Updated: 2018-11-27
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
10 participants
INTERVENTIONAL
2011-03-31
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intraocular Retinoblastoma Patients
Single group assignment of patients with intraocular retinoblastoma, unilateral or bilateral.
Melphalan hydrochloride
Drug administered intra-arterially (injection in the artery).
Standard dose:
2.5mg (3-6 month old) 3.0 mg (6-12 month old) 4.0 mg (1-3 year old) 5.0 mg (\>3 years old)
Dose modification: decrease standard dose by 25% if there are signs of toxicity. Increase the dose by 25% if there is inadequate tumor response.
Frequency: 2 treatment cycles at 3-4 week intervals, with a third treatment cycle administered if the tumor requires it.
Dose not to exceed 0.5mg/kg, per treatment cycle.
Interventions
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Melphalan hydrochloride
Drug administered intra-arterially (injection in the artery).
Standard dose:
2.5mg (3-6 month old) 3.0 mg (6-12 month old) 4.0 mg (1-3 year old) 5.0 mg (\>3 years old)
Dose modification: decrease standard dose by 25% if there are signs of toxicity. Increase the dose by 25% if there is inadequate tumor response.
Frequency: 2 treatment cycles at 3-4 week intervals, with a third treatment cycle administered if the tumor requires it.
Dose not to exceed 0.5mg/kg, per treatment cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with intraocular retinoblastoma, unilateral or bilateral, who would be treated either by systemic chemotherapy, EBR, or enucleation would be considered for this study.
Exclusion Criteria
* Patients with small, localized intraocular Rb amenable to focal therapy (laser or cryotherapy).
* Patients with extraocular disease evident on MRI (extension into the optic nerve), massive choroidal/uveal invasion (grade IIC or IID per ARET0332) or disease outside the globe evident on MRI or physical examination.
* Documented hypercoagulable disorders or vasculopathies.
18 Years
ALL
No
Sponsors
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
OTHER
Responsible Party
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Principal Investigators
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Monica Pearl, M.D.
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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The Johns Hopkins Hospital
Baltimore, Maryland, United States
Countries
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References
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Abramson DH, Dunkel IJ, Brodie SE, Kim JW, Gobin YP. A phase I/II study of direct intraarterial (ophthalmic artery) chemotherapy with melphalan for intraocular retinoblastoma initial results. Ophthalmology. 2008 Aug;115(8):1398-404, 1404.e1. doi: 10.1016/j.ophtha.2007.12.014. Epub 2008 Mar 14.
Abramson DH. Chemosurgery for retinoblastoma: what we know after 5 years. Arch Ophthalmol. 2011 Nov;129(11):1492-4. doi: 10.1001/archophthalmol.2011.354. No abstract available.
Other Identifiers
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NA_00040637
Identifier Type: OTHER
Identifier Source: secondary_id
J1071
Identifier Type: -
Identifier Source: org_study_id
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