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

Inclusion Criteria

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)