Intra-arterial Chemotherapy for the Treatment of Intraocular Retinoblastoma
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Intra-arterial Chemotherapy for the Treatment of Intraocular Retinoblastoma|
- Number of Patients Who Complete Therapy Without the Need for Additional Treatment Including Systemic Chemotherapy, External Beam Radiation, or Enucleation. [ Time Frame: Within the first six months after the initial treatment. ]The primary objective of this study is to show that intra-arterial delivery of the chemotherapeutic agent is successful in treating intraocular retinoblastoma, defined as avoiding systemic chemotherapy, external beam radiation, and enucleation.
|Study Start Date:||March 2011|
|Estimated Study Completion Date:||August 2021|
|Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
Intraocular Retinoblastoma Patients
Single group assignment of patients with intraocular retinoblastoma, unilateral or bilateral.
Drug: Melphalan hydrochloride
Drug administered intra-arterially (injection in the artery).
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 Name: Alkeran
Please refer to this study by its ClinicalTrials.gov identifier: NCT01293539
|United States, Maryland|
|The Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Monica Pearl, M.D.||Johns Hopkins University|