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

Purpose

OBJECTIVES:

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

Condition	Intervention	Phase
Lymphatic Malformations	Drug: picibanil	Phase II Phase III

Drug Information available for:

Picibanil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

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

Further study details as provided by FDA Office of Orphan Products Development:

Primary Outcome Measures:

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 ]

Enrollment:	150
Study Start Date:	April 2000
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Intervention Details:

Up to .2 mg per injection, given intralesionally every 6-8 weeks

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.

Eligibility

Ages Eligible for Study:	6 Months to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00010452

Locations


United States, California
	Children's Associated Medical Group
	San Diego, California, United States, 92123

United States, Colorado
	Children's Hospital of Denver
	Denver, Colorado, United States, 80218

United States, District of Columbia
	Childrens National Medical Center
	Washington, District of Columbia, United States

United States, Florida
	All Children's Hospital
	St. Petersburg, Florida, United States, 33701

United States, Iowa
	University of Iowa Hospitals and Clinics
	Iowa City, Iowa, United States, 52242

United States, Minnesota
	Children's Hospitals and Clinics - Minneapolis
	Minneapolis, Minnesota, United States, 55404

United States, New York
	SUNY Upstate Medical University
	Syracuse, New York, United States, 13210

United States, Oregon
	Oregon Health Sciences University
	Portland, Oregon, United States

United States, Tennessee
	Vanderbilt University
	Nashville, Tennessee, United States

United States, Texas
	Texas Pediatric Otolaryngology Center
	Houston, Texas, United States, 77030

United States, Virginia
	Children's Hospital of the Kings Daughter
	Norfolk, Virginia, United States, 23507

United States, Wisconsin
	Children's Hospital of Wisconsin
	Milwaukee, Wisconsin, United States, 53201
	University of Wisconsin Hospital and Clinics
	Madison, Wisconsin, United States, 53792-0001

Sponsors and Collaborators

University of Iowa

Chugai Pharmaceutical

Investigators


Study Chair:	Richard J Smith	University of Iowa

More Information

Responsible Party:	University of Iowa Health Care ( Richard JH Smith, MD )
Study ID Numbers:	199/15706, UIHC-FDR001774
First Received:	February 2, 2001
Last Updated:	March 28, 2008
ClinicalTrials.gov Identifier:	NCT00010452
Health Authority:	United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:

cystic hygroma

lymphangiomas

lymphatic malformations

Study placed in the following topic categories:

Lymphatic Abnormalities

Lymphatic Diseases

Picibanil

Congenital Abnormalities

Lymphangioma, Cystic

Additional relevant MeSH terms:

Lymphatic Vessel Tumors

Neoplasms

Neoplasms by Histologic Type

Antineoplastic Agents

Therapeutic Uses

Pharmacologic Actions

Lymphangioma

ClinicalTrials.gov processed this record on November 20, 2008

Sponsors and Collaborators:	University of Iowa Chugai Pharmaceutical
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00010452