NCT00010452

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2000

Longer than P75 for phase_2

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2000

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2001

Completed
Same day until next milestone

First Posted

Study publicly available on registry

February 2, 2001

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

March 25, 2015

Status Verified

January 1, 2008

Enrollment Period

6.2 years

First QC Date

February 2, 2001

Last Update Submit

March 24, 2015

Conditions

Lymphatic Malformations

Keywords

cystic hygromalymphangiomaslymphatic malformations

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

picibanilDRUG

Up to .2 mg per injection, given intralesionally every 6-8 weeks

Also known as: OK432

Eligibility Criteria

Age6 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (13)

Children's Associated Medical Group

San Diego, California, 92123, United States

Location

Children's Hospital of Denver

Denver, Colorado, 80218, United States

Location

Childrens National Medical Center

Washington D.C., District of Columbia, United States

Location

All Children's Hospital

St. Petersburg, Florida, 33701, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Children's Hospitals and Clinics - Minneapolis

Minneapolis, Minnesota, 55404, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Oregon Health Sciences University

Portland, Oregon, United States

Location

Vanderbilt University

Nashville, Tennessee, United States

Location

Texas Pediatric Otolaryngology Center

Houston, Texas, 77030, United States

Location

Children's Hospital of the Kings Daughter

Norfolk, Virginia, 23507, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792-0001, United States

Location

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53201, United States

Location

Related Publications (1)

  • 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.

    PMID: 19117316DERIVED

MeSH Terms

Conditions

Lymphatic AbnormalitiesLymphangioma, CysticLymphangioma

Interventions

Picibanil

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeoplasm, Lymphatic TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Biological ProductsComplex Mixtures

Study Officials

  • Richard J Smith

    University of Iowa

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 2, 2001

First Posted

February 2, 2001

Study Start

April 1, 2000

Primary Completion

June 1, 2006

Study Completion

November 1, 2007

Last Updated

March 25, 2015

Record last verified: 2008-01

Locations

US(13)