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

Tracking Information

First Received Date ^ICMJE

February 2, 2001

Last Updated Date

March 28, 2008

Start Date ^ICMJE

April 2000

Primary Completion Date

June 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00010452 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

OBJECTIVES:

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

Detailed 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.

Study Phase

Phase II, Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Lymphatic Malformations

Intervention ^ICMJE

Drug: picibanil

Study Arms / Comparison Groups

Publications *

Smith MC, Zimmerman MB, Burke DK, Bauman NM, Sato Y, Smith RJ; OK-432 Collaborative Study Group. Efficacy and safety of OK-432 immunotherapy of lymphatic malformations. Laryngoscope. 2009 Jan;119(1):107-15.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

150

Completion Date

Primary Completion Date

June 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

6 Months to 18 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00010452

Responsible Party

Richard JH Smith, MD, University of Iowa Health Care

Study ID Numbers ^ICMJE

199/15706, UIHC-FDR001774

Study Sponsor ^ICMJE

University of Iowa

Collaborators ^ICMJE

Chugai Pharmaceutical

Investigators ^ICMJE

Study Chair:

Richard J Smith

University of Iowa

Information Provided By

FDA Office of Orphan Products Development

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP