Status:
COMPLETED
OK432 (Picibanil) in the Treatment of Lymphatic Malformations
Lead Sponsor:
Richard JH Smith
Conditions:
Lymphatic Malformations
Eligibility:
All Genders
6-17 years
Phase:
PHASE2
Brief Summary
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 m...
Detailed Description
Lymphatic malformations are uncommon tumors that represent localized malformations in the development of the lymphatic system. They typically present in children under 2 years of age and in almost 50%...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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)
Key Trial Info
Start Date :
October 5 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2018
Estimated Enrollment :
275 Patients enrolled
Trial Details
Trial ID
NCT03427619
Start Date
October 5 2005
End Date
April 30 2018
Last Update
November 23 2021
Active Locations (14)
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1
Rady Children's Hospital & Health Center San Diego
San Diego, California, United States, 92123
2
The Children's Hospital of Denver
Denver, Colorado, United States, 80218
3
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
4
All Children's Hospital
St. Petersburg, Florida, United States, 33701