Study of Picibanil (OK432) Sclerotherapy in Children With Macrocystic Lymphatic Malformations
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by FDA Office of Orphan Products Development.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
University of Iowa
Collaborator:
Chugai Pharmaceutical
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00010452
First received: February 2, 2001
Last updated: March 28, 2008
Last verified: January 2008
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Purpose
OBJECTIVES:
I. Determine the efficacy of picibanil sclerotherapy in children with macrocystic lymphangioma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphatic Malformations |
Drug: picibanil |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Treatment of Cystic Hygroma (Lymphangiomas) in Children- Picibanil(OK432) Sclerotherapy-Multicenter Trial |
Further study details as provided by FDA Office of Orphan Products Development:
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. [ Time Frame: indefinate ] [ Designated as safety issue: Yes ]
| Enrollment: | 150 |
| Study Start Date: | April 2000 |
| Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: picibanil
Up to .2 mg per injection, given intralesionally every 6-8 weeks
Other Name: OK432
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.
Eligibility| Ages Eligible for Study: | 6 Months to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00010452
Locations
| United States, California | |
| Children's Associated Medical Group | |
| San Diego, California, United States, 92123 | |
| United States, Colorado | |
| Children's Hospital of Denver | |
| Denver, Colorado, United States, 80218 | |
| United States, District of Columbia | |
| Childrens National Medical Center | |
| Washington, District of Columbia, United States | |
| United States, Florida | |
| All Children's Hospital | |
| St. Petersburg, Florida, United States, 33701 | |
| United States, Iowa | |
| University of Iowa Hospitals and Clinics | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Minnesota | |
| Children's Hospitals and Clinics - Minneapolis | |
| Minneapolis, Minnesota, United States, 55404 | |
| United States, New York | |
| SUNY Upstate Medical University | |
| Syracuse, New York, United States, 13210 | |
| United States, Oregon | |
| Oregon Health Sciences University | |
| Portland, Oregon, United States | |
| United States, Tennessee | |
| Vanderbilt University | |
| Nashville, Tennessee, United States | |
| United States, Texas | |
| Texas Pediatric Otolaryngology Center | |
| Houston, Texas, United States, 77030 | |
| United States, Virginia | |
| Children's Hospital of the Kings Daughter | |
| Norfolk, Virginia, United States, 23507 | |
| United States, Wisconsin | |
| University of Wisconsin Hospital and Clinics | |
| Madison, Wisconsin, United States, 53792-0001 | |
| Children's Hospital of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53201 | |
Sponsors and Collaborators
University of Iowa
Chugai Pharmaceutical
Investigators
| Study Chair: | Richard J Smith | University of Iowa |
More Information
No publications provided by FDA Office of Orphan Products Development
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Richard JH Smith, MD, University of Iowa Health Care |
| ClinicalTrials.gov Identifier: | NCT00010452 History of Changes |
| Other Study ID Numbers: | 199/15706, UIHC-FDR001774 |
| Study First Received: | February 2, 2001 |
| Last Updated: | March 28, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by FDA Office of Orphan Products Development:
|
cystic hygroma lymphangiomas lymphatic malformations |
Additional relevant MeSH terms:
|
Congenital Abnormalities Lymphangioma Lymphangioma, Cystic Lymphatic Abnormalities Lymphatic Vessel Tumors Neoplasms by Histologic Type |
Neoplasms Lymphatic Diseases Picibanil Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013