OK432 (Picibanil) in the Treatment of Lymphatic Malformations

Completed · Phase 2

Conditions studied: Lymphatic Malformations

In brief

Standard of care for Lymphatic Malformations has been surgical excision. We have been using OK432/Picibanil (generously supplied by Chugai Pharmaceuticals in Japan) since 1992 with great success for macrocystic disease. The objective of the study was to provide OK-432 immunotherapy to subjects with macrocystic or mixed (\> 50% macrocystic) lymphatic malformations (LMs) and investigate the efficacy and safety of OK 432 as a treatment option in subjects with LMs.

Key facts

Study ID

NCT03427619

Run by

Richard JH Smith

People needed

275

Starts

2005-10-05

Expected to finish

2018-04-30

Last updated by the study team

2021-11-23

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• To be eligible to receive OK432 immunotherapy
• Patients must be ages 6 months to 17 years
• Patients must have a macrocystic Lymphatic Malformation
• Patients may have had surgical treatment for their Lymphatic Malformation
• Patients must have an imaging study to confirm the diagnosis of a macrocystic or mixed Lymphatic Malformation An MRI is preferred over a CT scan (an ultrasound may be used between injections if warranted, however an MRI or CT should be done pre and post treatment)

You may not qualify if…

• Penicillin allergy
• Women who are pregnant or nursing
• Patients who present with a temperature of 100.5 degrees F or greater
• Patients with mixed hemangioma-lymphangioma lesions
• Patients with a history OR a family history of rheumatic heart disease or post-streptococcal glomerulonephritis
• Patients with hemodynamic instability and respiratory failure
• Patients with a history OR a family history of obsessive-compulsive, tic disorders, or PANDA (pediatric autoimmune neuro-psychiatric disorder associated with streptococcal infections)
• Patients who demonstrate abnormalities in the history, physical examination or laboratory analysis which may indicate significant hepatic, hematologic, or renal disease
• Patients who are not in "good general health" (including patients with congenital disorders, chronic diseases, immunologic dysfunction, transplant recipients)

Where it is running

• Rady Children's Hospital & Health Center San Diego — San Diego, California, United States
• The Children's Hospital of Denver — Denver, Colorado, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• All Children's Hospital — St. Petersburg, Florida, United States
• Richard Smith, MD — Iowa City, Iowa, United States
• Spectrum Health-SHMG Ear, Nose, & Throat — Grand Rapids, Michigan, United States
• Children's Hospitals & Clinics of Minnesota - Minneapolis — Minneapolis, Minnesota, United States
• SUNY Health Science Center — Syracuse, New York, United States
• Oregon Health Sciences University — Portland, Oregon, United States
• Vanderbilt University Hospital — Nashville, Tennessee, United States
• Children's ENT of Houston — Houston, Texas, United States
• Children's Hospital of the Kings Daughter — Norfolk, Virginia, United States
• University of Wisconsin Hospital & Clinic — Madison, Wisconsin, United States
• Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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