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

March 24, 2015 updated by: University of Iowa

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

OBJECTIVES:

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92123
        • Children's Associated Medical Group
    • Colorado
      • Denver, Colorado, United States, 80218
        • Children's Hospital of Denver
    • District of Columbia
      • Washington, District of Columbia, United States
        • Childrens National Medical Center
    • Florida
      • St. Petersburg, Florida, United States, 33701
        • All Children's Hospital
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Children's Hospitals and Clinics - Minneapolis
    • New York
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University
    • Oregon
      • Portland, Oregon, United States
        • Oregon Health Sciences University
    • Tennessee
      • Nashville, Tennessee, United States
        • Vanderbilt University
    • Texas
      • Houston, Texas, United States, 77030
        • Texas Pediatric Otolaryngology Center
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Children's Hospital of the Kings Daughter
    • Wisconsin
      • Madison, Wisconsin, United States, 53792-0001
        • University of Wisconsin Hospital and Clinics
      • Milwaukee, Wisconsin, United States, 53201
        • Children's Hospital of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
indefinate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Iowa

Investigators

  • Study Chair: Richard J Smith, University of Iowa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2000

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

February 2, 2001

First Submitted That Met QC Criteria

February 1, 2001

First Posted (Estimate)

February 2, 2001

Study Record Updates

Last Update Posted (Estimate)

March 25, 2015

Last Update Submitted That Met QC Criteria

March 24, 2015

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 199/15706
  • UIHC-FDR001774

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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