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

Sponsor

University of Iowa (Other)

Overall Status

Completed

CT.gov ID

NCT00010452

Collaborator

(none)

150

Enrollment

Locations

Duration (Months)

11.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

OBJECTIVES:

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

Condition or Disease	Intervention/Treatment	Phase
Lymphatic Malformations	Drug: picibanil	Phase 2/Phase 3

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.

Completion date provided represents the completion date of the grant per OOPD records

Study Design

Study Type:

Interventional

Actual Enrollment :

150 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2000

Actual Primary Completion Date :

Jun 1, 2006

Actual Study Completion Date :

Nov 1, 2007

Outcome Measures

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. [indefinate]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Children's Associated Medical Group	San Diego	California	United States	92123
2	Children's Hospital of Denver	Denver	Colorado	United States	80218
3	Childrens National Medical Center	Washington	District of Columbia	United States
4	All Children's Hospital	St. Petersburg	Florida	United States	33701
5	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242
6	Children's Hospitals and Clinics - Minneapolis	Minneapolis	Minnesota	United States	55404
7	SUNY Upstate Medical University	Syracuse	New York	United States	13210
8	Oregon Health Sciences University	Portland	Oregon	United States
9	Vanderbilt University	Nashville	Tennessee	United States
10	Texas Pediatric Otolaryngology Center	Houston	Texas	United States	77030
11	Children's Hospital of the Kings Daughter	Norfolk	Virginia	United States	23507
12	University of Wisconsin Hospital and Clinics	Madison	Wisconsin	United States	53792-0001
13	Children's Hospital of Wisconsin	Milwaukee	Wisconsin	United States	53201