OK432 (Picibanil) in the Treatment of Lymphatic Malformations

• Status: Completed
• Trial end date: 2018-04-30
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Richard JH Smith
• Treatments: Picibanil

Criteria

Inclusion Criteria:

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 Criteria:

• 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)