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

University of Iowa

Status and phase

Completed

Phase 3

Phase 2

Conditions

Lymphatic Malformations

Treatments

Drug: picibanil

Study type

Interventional

Funder types

Other

Identifiers

NCT00010452

199/15706

UIHC-FDR001774

Details and patient eligibility

About

OBJECTIVES:

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

Full description

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

Enrollment

150 patients

Sex

All

Ages

6 months to 18 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)