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


Phase 2/Phase 3
6 Months
18 Years
Open (Enrolling)
Both
Lymphatic Malformations

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Trial Information

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


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.

Inclusion 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)

Type of Study:

Interventional

Study Design:

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

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.

Outcome Time Frame:

indefinate

Safety Issue:

Yes

Principal Investigator

Richard J Smith

Investigator Role:

Study Chair

Investigator Affiliation:

University of Iowa

Authority:

United States: Federal Government

Study ID:

199/15706

NCT ID:

NCT00010452

Start Date:

April 2000

Completion Date:

Related Keywords:

  • Lymphatic Malformations
  • cystic hygroma
  • lymphangiomas
  • lymphatic malformations
  • Congenital Abnormalities
  • Lymphangioma
  • Lymphangioma, Cystic
  • Lymphatic Abnormalities

Name

Location

Childrens National Medical CenterWashington, District of Columbia  
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
Children's Hospital of DenverDenver, Colorado  80218
All Children's HospitalSt. Petersburg, Florida  33701
Children's Hospitals and Clinics - MinneapolisMinneapolis, Minnesota  55404
University of Wisconsin Hospital and ClinicsMadison, Wisconsin  53792-0001
Vanderbilt UniversityNashville, Tennessee  37232-6305
Children's Associated Medical GroupSan Diego, California  92123
SUNY Upstate Medical UniversitySyracuse, New York  13210
Oregon Health Sciences UniversityPortland, Oregon  
Texas Pediatric Otolaryngology CenterHouston, Texas  77030
Children's Hospital of the Kings DaughterNorfolk, Virginia  23507
Children's Hospital of WisconsinMilwaukee, Wisconsin  53201