Spots Global Cancer Trial Database for Study of Picibanil (OK432) Sclerotherapy in Children With Macrocystic Lymphatic Malformations
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Trial Identification
Brief Title: Study of Picibanil (OK432) Sclerotherapy in Children With Macrocystic Lymphatic Malformations
Official Title: Treatment of Cystic Hygroma (Lymphangiomas) in Children- Picibanil(OK432) Sclerotherapy-Multicenter Trial
Study ID: NCT00010452
Conditions
Interventions
Study Description
Brief Summary: OBJECTIVES: I. Determine the efficacy of picibanil sclerotherapy in children with macrocystic lymphangioma.
Detailed 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
Eligibility
Minimum Age: 6 Months
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Children's Associated Medical Group, San Diego, California, United States
Children's Hospital of Denver, Denver, Colorado, United States
Childrens National Medical Center, Washington, District of Columbia, United States
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
Children's Hospital of the Kings Daughter, Norfolk, Virginia, United States
University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States
Children's Hospital of Wisconsin, Milwaukee, Wisconsin, United States
Contact Details
Name: Richard J Smith
Affiliation: University of Iowa
Role: STUDY_CHAIR
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