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

• Register: ClinicalTrials.gov
• Last refreshed on: 7 April 2015
• Main ID: NCT00010452
• Date of registration: 02/02/2001
• Prospective Registration: No
• Primary sponsor: University of Iowa
• Public title: Study of Picibanil (OK432) Sclerotherapy in Children With Macrocystic Lymphatic Malformations
• Scientific title: Treatment of Cystic Hygroma (Lymphangiomas) in Children- Picibanil(OK432) Sclerotherapy-Multicenter Trial
• Date of first enrolment: April 2000
• Target sample size: 150
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00010452
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2/Phase 3

Countries of recruitment

United States

Contacts

• Name: Richard J Smith
• Affiliation: University of Iowa

Key inclusion & 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)



Age minimum: 6 Months
Age maximum: 18 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Lymphatic Malformations

Intervention(s)

Drug: picibanil

Primary Outcome(s)

to establish whether OK432 sclerotherapy is an effective form of treatment for lymphatic malformations versus the traditional form of treatment, which is surgical excision. [Time Frame: indefinate]

Secondary ID(s)

UIHC-FDR001774

199/15706

Source(s) of Monetary Support

Please refer to primary and secondary sponsors