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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by FDA Office of Orphan Products Development.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Chugai Pharmaceutical
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00010452
First received: February 2, 2001
Last updated: March 28, 2008
Last verified: January 2008
  Purpose

OBJECTIVES:

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


Condition Intervention Phase
Lymphatic Malformations
Drug: picibanil
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Cystic Hygroma (Lymphangiomas) in Children- Picibanil(OK432) Sclerotherapy-Multicenter Trial

Resource links provided by NLM:


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:
    Drug: picibanil
    Up to .2 mg per injection, given intralesionally every 6-8 weeks
    Other Name: OK432
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792-0001
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53201
Sponsors and Collaborators
University of Iowa
Chugai Pharmaceutical
Investigators
Study Chair: Richard J Smith University of Iowa
  More Information

No publications provided by FDA Office of Orphan Products Development

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Richard JH Smith, MD, University of Iowa Health Care
ClinicalTrials.gov Identifier: NCT00010452     History of Changes
Other Study ID Numbers: 199/15706, UIHC-FDR001774
Study First Received: February 2, 2001
Last Updated: March 28, 2008
Health Authority: United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:
cystic hygroma
lymphangiomas
lymphatic malformations

Additional relevant MeSH terms:
Congenital Abnormalities
Lymphatic Abnormalities
Lymphatic Diseases
Picibanil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014