Intra-arterial Chemotherapy for the Treatment of Intraocular Retinoblastoma
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|ClinicalTrials.gov Identifier: NCT01293539|
Recruitment Status : Terminated (IAC is now recognized as part of standard of care treatment options in the US.)
First Posted : February 10, 2011
Results First Posted : July 21, 2017
Last Update Posted : August 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Retinoblastoma||Drug: Melphalan hydrochloride||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intra-arterial Chemotherapy for the Treatment of Intraocular Retinoblastoma|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||August 2016|
|Estimated Study Completion Date :||August 2021|
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
- 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.
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): NCT01293539
|United States, Maryland|
|The Johns Hopkins Hospital|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Monica Pearl, M.D.||Johns Hopkins University|