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

Primary Purpose

Lymphatic Malformations

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
picibanil
Sponsored by
University of Iowa
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphatic Malformations focused on measuring cystic hygroma, lymphangiomas, lymphatic malformations

Eligibility Criteria

6 Months - 18 Years (Child, Adult)All SexesDoes not accept 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)

Sites / Locations

  • Children's Associated Medical Group
  • Children's Hospital of Denver
  • Childrens National Medical Center
  • All Children's Hospital
  • University of Iowa Hospitals and Clinics
  • Children's Hospitals and Clinics - Minneapolis
  • SUNY Upstate Medical University
  • Oregon Health Sciences University
  • Vanderbilt University
  • Texas Pediatric Otolaryngology Center
  • Children's Hospital of the Kings Daughter
  • University of Wisconsin Hospital and Clinics
  • Children's Hospital of Wisconsin

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
February 2, 2001
Last Updated
March 24, 2015
Sponsor
University of Iowa
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1. Study Identification

Unique Protocol Identification Number
NCT00010452
Brief Title
Study of Picibanil (OK432) Sclerotherapy in Children With Macrocystic Lymphatic Malformations
Official Title
Treatment of Cystic Hygroma (Lymphangiomas) in Children- Picibanil(OK432) Sclerotherapy-Multicenter Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
April 2000 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Iowa

4. Oversight

5. Study Description

Brief Summary
OBJECTIVES: I. Determine the efficacy of picibanil sclerotherapy in children with macrocystic lymphangioma.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphatic Malformations
Keywords
cystic hygroma, lymphangiomas, lymphatic malformations

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
picibanil
Other Intervention Name(s)
OK432
Intervention Description
Up to .2 mg per injection, given intralesionally every 6-8 weeks
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard J Smith
Organizational Affiliation
University of Iowa
Official's Role
Study Chair
Facility Information:
Facility Name
Children's Associated Medical Group
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Children's Hospital of Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Childrens National Medical Center
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
All Children's Hospital
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Children's Hospitals and Clinics - Minneapolis
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Oregon Health Sciences University
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Texas Pediatric Otolaryngology Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Children's Hospital of the Kings Daughter
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
University of Wisconsin Hospital and Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-0001
Country
United States
Facility Name
Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53201
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19117316
Citation
Smith MC, Zimmerman MB, Burke DK, Bauman NM, Sato Y, Smith RJ; OK-432 Collaborative Study Group. Efficacy and safety of OK-432 immunotherapy of lymphatic malformations. Laryngoscope. 2009 Jan;119(1):107-15. doi: 10.1002/lary.20041.
Results Reference
derived

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

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