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

Lymphatic Malformations Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00010452
• Other study ID #: 199/15706
• Secondary ID: UIHC-FDR001774
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 2, 2001
• Last updated: March 24, 2015
• Start date: April 2000
• Est. completion date: November 2007

Study information

• Verified date: January 2008
• Source: FDA Office of Orphan Products Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

OBJECTIVES:

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 2007
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 18 Years

Eligibility

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)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congenital Abnormalities
• Lymphatic Abnormalities
• Lymphatic Malformations

Intervention

Drug:
• picibanil
Up to .2 mg per injection, given intralesionally every 6-8 weeks

Locations

Country	Name	City	State
United States	Children's Hospital of Denver	Denver	Colorado
United States	Texas Pediatric Otolaryngology Center	Houston	Texas
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin
United States	Children's Hospitals and Clinics - Minneapolis	Minneapolis	Minnesota
United States	Vanderbilt University	Nashville	Tennessee
United States	Children's Hospital of the Kings Daughter	Norfolk	Virginia
United States	Oregon Health Sciences University	Portland	Oregon
United States	Children's Associated Medical Group	San Diego	California
United States	All Children's Hospital	St. Petersburg	Florida
United States	SUNY Upstate Medical University	Syracuse	New York
United States	Childrens National Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to establish whether OK432 sclerotherapy is an effective form of treatment for lymphatic malformations versus the traditional form of treatment, which is surgical excision.		indefinate	Yes