OBJECTIVES: I. Determine the efficacy of picibanil sclerotherapy in children with macrocystic lymphangioma.
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Up to .2 mg per injection, given intralesionally every 6-8 weeks
Children's Associated Medical Group
San Diego, California, United States
Children's Hospital of Denver
Denver, Colorado, United States
Childrens National Medical Center
Washington D.C., District of Columbia, United States
to establish whether OK432 sclerotherapy is an effective form of treatment for lymphatic malformations versus the traditional form of treatment, which is surgical excision.
Time frame: indefinate
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All Children's Hospital
St. Petersburg, Florida, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Children's Hospitals and Clinics - Minneapolis
Minneapolis, Minnesota, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Oregon Health Sciences University
Portland, Oregon, United States
Vanderbilt University
Nashville, Tennessee, United States
Texas Pediatric Otolaryngology Center
Houston, Texas, United States
...and 3 more locations