Study of Picibanil (OK432) Sclerotherapy in Children With Macrocystic Lymphatic Malformations
NCT ID: NCT00010452
Last Updated: 2015-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
150 participants
INTERVENTIONAL
2000-04-30
2007-11-30
Brief Summary
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I. Determine the efficacy of picibanil sclerotherapy in children with macrocystic lymphangioma.
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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picibanil
Up to .2 mg per injection, given intralesionally every 6-8 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
--Disease Characteristics--
* Diagnosis of macrocystic lymphangioma of the head and/or neck Cystic spaces at least 2.0 mL confirmed by radiographic imaging (MRI or CT) Mixed lymphangiomas (macrocystic and microcystic disease) allowed if macrocystic component comprises at least 50% of the total disease burden
* No mixed hemangioma-lymphangioma lesions
* At least 6 months since prior surgery for lymphangioma
--Patient Characteristics--
* Hematopoietic: No clinically significant hematologic disease No hemodynamic instability
* Hepatic: No clinically significant hepatic disorder
* Renal: No clinically significant renal disease No personal or family history of post-streptococcal glomerulonephritis
* Cardiovascular: No personal or family history of rheumatic heart disease
* Pulmonary: No respiratory failure
Other:
* Not pregnant or nursing
* Negative pregnancy test
* No history of allergy to penicillin
* No concurrent temperature of 100.5 degrees or greater
* No active upper respiratory infection
* No personal or family history of obsessive-compulsive or tic disorders
* No personal or family history of PANDA (pediatric autoimmune neuro- psychiatric disorder associated with streptococcal infections)
* No history of hypersensitivity to iodine, Omnipaque, or gadolinium (if fluoroscopy is considered necessary)
* No history of poor health (including congenital disorders, chronic diseases, or immunologic dysfunction)
6 Months
18 Years
ALL
No
Sponsors
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University of Iowa
OTHER
Responsible Party
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University of Iowa Health Care
Principal Investigators
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Richard J Smith
Role: STUDY_CHAIR
University of Iowa
Locations
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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
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
Countries
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References
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Smith MC, Zimmerman MB, Burke DK, Bauman NM, Sato Y, Smith RJ; OK-432 Collaborative Study Group. Efficacy and safety of OK-432 immunotherapy of lymphatic malformations. Laryngoscope. 2009 Jan;119(1):107-15. doi: 10.1002/lary.20041.
Other Identifiers
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UIHC-FDR001774
Identifier Type: -
Identifier Source: secondary_id
199/15706
Identifier Type: -
Identifier Source: org_study_id
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