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

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

OBJECTIVES:

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

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

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)