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Lymphatic MalformationsPhase 2/3NCT00010452

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

A Phase 2/3 study testing picibanil in people with Lymphatic Malformations, run by University of Iowa at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

OBJECTIVES: I. Determine the efficacy of picibanil sclerotherapy in children with macrocystic lymphangioma. Read more about this study

Who is it for?
Ages 6 months to 18 years
Conditions the study is for
Lymphatic Malformations
What is being tested?
picibanil
Type of treatment
Injection or infusion
How many people
150 participants
Where
13 sitesUnited States
Study dates
Apr 2000to Nov 2007
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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)

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • Children's Hospital of Denver

    Denver, Colorado, 80218

  • Texas Pediatric Otolaryngology Center

    Houston, Texas, 77030

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792-0001

  • Children's Hospital of Wisconsin

    Milwaukee, Wisconsin, 53201

  • Children's Hospitals and Clinics - Minneapolis

    Minneapolis, Minnesota, 55404

  • Vanderbilt University

    Nashville, Tennessee

  • Children's Hospital of the Kings Daughter

    Norfolk, Virginia, 23507

  • Oregon Health Sciences University

    Portland, Oregon

  • Children's Associated Medical Group

    San Diego, California, 92123

  • All Children's Hospital

    St. Petersburg, Florida, 33701

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Childrens National Medical Center

    Washington D.C., District of Columbia

Other trials in United States

About this study

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

OBJECTIVES:

  1. 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

Being tested
picibanil
Keywords
cystic hygroma, lymphangiomas, lymphatic malformations
Medical subject headings
Lymphatic Abnormalities, Lymphangioma, Cystic, Lymphangioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • picibanilDrug

    Also called OK432

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: indefinate

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2001 (estimated)
  2. Study startApr 2000
  3. Primary completionJun 2006
  4. Study completionNov 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00010452
Sponsor's protocol ID
199/15706
Other IDs
UIHC-FDR001774
Status last verified
Jan 2008
First submitted
2 Feb 2001
Last updated
25 Mar 2015
Results posted
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing picibanil in people with Lymphatic Malformations, run by University of Iowa at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00010452, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2015.

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