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

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

Summary

OBJECTIVES:

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Iowa
• Treatments: Picibanil

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)