Status and phase
Conditions
Treatments
About
OBJECTIVES:
I. Determine the efficacy of picibanil sclerotherapy in children with macrocystic lymphangioma.
Full description
PROTOCOL OUTLINE: This is a multicenter study. Patients are stratified according to prior treatment (no prior treatment vs prior surgical treatment) and geographic area.
Patients who meet all study criteria are put in the "Immediate Treatment Group." Patients receive an intralesional injection of picibanil (OK432) with the aid of ultrasonography or transillumination for localization of cysts. Treatment repeats every 6-8 weeks for a total of up to 4 injections.
After completion of treatment, patients are followed at 6 months, 1 year, and 2 years.
Completion date provided represents the completion date of the grant per OOPD records
Enrollment
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Inclusion and exclusion criteria
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Patient Characteristics--
Other:
Primary purpose
Allocation
Interventional model
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Data sourced from clinicaltrials.gov
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