Study of Picibanil (OK432) Sclerotherapy in Children With Macrocystic Lymphatic Malformations

Study Overview
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Brief Summary
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OBJECTIVES: I. Determine the efficacy of picibanil sclerotherapy in children with macrocystic lymphangioma.

Detailed Description
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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

Official Title
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Treatment of Cystic Hygroma (Lymphangiomas) in Children- Picibanil(OK432) Sclerotherapy-Multicenter Trial

Conditions
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Lymphatic Malformations

Intervention / Treatment
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* Drug: picibanil


Participation Criteria
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Eligibility Criteria
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PROTOCOL ENTRY 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)

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: picibanil|Up to .2 mg per injection, given intralesionally every 6-8 weeks|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to establish whether OK432 sclerotherapy is an effective form of treatment for lymphatic malformations versus the traditional form of treatment, which is surgical excision. |  | indefinate | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cystic hygroma, lymphangiomas, lymphatic malformations