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

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

This study is ongoing, but not recruiting participants.

Study NCT00010452. Last updated on March 28, 2008. Information provided by FDA Office of Orphan Products Development

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

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 ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

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 ]

Secondary Outcome Measure ^†

Condition ^†

Lymphatic Malformations

Intervention ^†

Drug: picibanil

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

150

Start Date ^†

April 2000

Completion Date

Eligibility 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)

Gender

Both

Ages

6 Months to 18 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00010452

Organization ID

199/15706

Secondary IDs ^††

UIHC-FDR001774

Study Sponsor ^†

University of Iowa

Collaborators ^††

Chugai Pharmaceutical

Investigators ^†

Study Chair:

Richard J Smith

University of Iowa

Information Provided By

FDA Office of Orphan Products Development

Verification Date

January 2008

First Received Date ^†

February 2, 2001

Last Updated Date

March 28, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.