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

Sponsored by University of Iowa

About this trial

Last updated 11 years ago

Study ID

199/15706

Status

Completed

Type

Interventional

Phase

Phase 2

Placebo

No

Accepting

6 to 18 Years
All Sexes

Trial Timing

Ended 19 years ago

What is this trial about?

OBJECTIVES: I. Determine the efficacy of picibanil sclerotherapy in children with macrocystic lymphangioma.

What are the Participation Requirements?

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)