Clinical trial · Interventional
Study of Picibanil (OK432) Sclerotherapy in Children With Macrocystic Lymphatic Malformations
Treatment of Cystic Hygroma (Lymphangiomas) in Children- Picibanil(OK432) Sclerotherapy-Multicenter Trial
NCT00010452CI-TRIAL-00017262completedPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
OBJECTIVES: I. Determine the efficacy of picibanil sclerotherapy in children with macrocystic lymphangioma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphatic Malformations | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| picibanil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- 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.
- timeFrame
- indefinate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Months
- Maximum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDSmith 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 19117316