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CompletedNCT00010452Updated Mar 25, 2015

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

A Phase 2/3 interventional study of picibanil in Lymphatic Malformations, sponsored by University of Iowa. Completed at 13 sites in United States. Open to participants aged 6 Months to 18 Years. Per ClinicalTrials.gov, last updated 2015-03-25.

Sponsored by University of Iowa · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Ages
6 Months to 18 Years
Sex
All
01

Study summary

OBJECTIVES:

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

Read the 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

02

Conditions studied

  • Lymphatic Malformations

Keywords

  • cystic hygroma
  • lymphangiomas
  • lymphatic malformations
03

In context

Lymphatic Abnormalities

42 studies on the registry are indexed under Lymphatic Abnormalities; 17 are open to participants now.

This study's enrollment of 150 is above the median of 46 across 28 interventional studies indexed under Lymphatic Abnormalities.

Browse Lymphatic Abnormalities studies →

Lead sponsor

University of Iowa is the lead sponsor of 279 studies on the registry; 33 are open to participants now.

Of its 45 completed or terminated interventional studies of FDA-regulated products, 40 (89%) have results posted.

Browse University of Iowa studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 18 Years
Sexes eligible
All
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 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 neuro- psychiatric disorder associated with streptococcal infections)
  • No history of to iodine, Omnipaque, or gadolinium (if fluoroscopy is considered necessary)
  • No history of poor health (including congenital disorders, chronic diseases, or immunologic dysfunction)
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (actual)

Interventions

  • Drugpicibanil

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

    Also known as: OK432

06

What researchers measure

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.

    Time frame: indefinate

07

Study locations

13 sites
  • Children's Associated Medical Group
    San Diego, California 92123, United States
  • Children's Hospital of Denver
    Denver, Colorado 80218, United States
  • Childrens National Medical Center
    Washington, District of Columbia, United States
  • All Children's Hospital
    St. Petersburg, Florida 33701, United States
  • University of Iowa Hospitals and Clinics
    Iowa City, Iowa 52242, United States
  • Children's Hospitals and Clinics - Minneapolis
    Minneapolis, Minnesota 55404, United States
  • SUNY Upstate Medical University
    Syracuse, New York 13210, United States
  • Oregon Health Sciences University
    Portland, Oregon, United States
  • Vanderbilt University
    Nashville, Tennessee, United States
  • Texas Pediatric Otolaryngology Center
    Houston, Texas 77030, United States
  • Children's Hospital of the Kings Daughter
    Norfolk, Virginia 23507, United States
  • University of Wisconsin Hospital and Clinics
    Madison, Wisconsin 53792-0001, United States
  • Children's Hospital of Wisconsin
    Milwaukee, Wisconsin 53201, United States
08

References and documents

Publications

  • 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. PubMed 19117316 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2000, a primary completion of Jun 2006 and a completion of Nov 2007. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 2, 2001
First posted
Feb 2, 2001
Start
Apr 2000
Primary completionActual
Jun 2006
CompletionActual
Nov 2007
Last update
Mar 25, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 25, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00010452
Lead sponsor
University of Iowa
First posted
Feb 2, 2001
Start date
Apr 2000
Primary completion
Jun 2006
Completion
Nov 2007
Last update
Mar 25, 2015

Study contacts

Richard J Smith
study chair · University of Iowa
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.

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