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
Status
Type
Phase
Placebo
Accepting
Trial Timing
Ended 19 years ago
What is this trial about?
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)
