OK432 (Picibanil) in the Treatment of Lymphatic Malformations
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|ClinicalTrials.gov Identifier: NCT03427619|
Recruitment Status : Completed
First Posted : February 9, 2018
Last Update Posted : December 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Lymphatic Malformations||Drug: OK432||Phase 4|
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% of the cases, are diagnosed at birth. There is neither a racial nor a sexual tendency. The malformations can occur anywhere on the body, but typically they are in the head/neck area.
Morbidity can be significant. Besides the obvious cosmetic deformity caused by these tumors, there is risk of infection and airway compromise and even obstruction. However, effective therapeutic options are limited. Small lesions can be observed, although spontaneous resolution is unlikely. For larger lesions, surgery has been the traditional form of therapy. In the head and neck, in particular, lymphangiomas typically wrap themselves around major neurovascular structures, making total excision removal difficult, if not impossible, and thus the likelihood of recurrence is quite high.
Because of these surgical limitations, alternate therapies have been considered; including cryotherapy, diathermy, and chemical sclerotherapy.
The investigators experience with using the drug for macrocystic disease(large cysts) since 1992 in the United States has been very promising compared to traditional surgery. Recurrence rate to date, has been very minimal as well. (<2%)
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||701 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||All eligible participants receive the actual drug.|
|Masking:||None (Open Label)|
|Official Title:||OK432 (Picibanil) in the Treatment of Lymphatic Malformations|
|Actual Study Start Date :||January 1, 1998|
|Actual Primary Completion Date :||October 22, 2018|
|Actual Study Completion Date :||October 22, 2018|
Experimental: OK432 (Picibanil)
There is no control in this study. All participants will receive the actual drug -OK432. With each injection they may receive .1mg-.2mg 6-12 weeks apart up to 4 injections total.
OK432 will be injected at dosage of .1mg-.2mg 6-12 weeks apart up to 4 injections total.
Other Name: Picibanil
- Determine the response rate of OK432 in children with symptomatic Lymphatic Malformations [ Time Frame: through study completion --approximately the next 5 years ]Response rate will be assessed radio-graphically after the final injection using the Clinical Staging Classification System and de Serres staging system.Images will be used and orthogonal measurements of LM size will be used to calculate volume/size in cubic centimeters (cc). Response rate to OK-432 immunotherapy will be recorded as percentage reduction in volume and graded as complete (90%-100% reduction in volume), substantial (60%-89% reduction in volume), incomplete (20%-59% reduction in volume), or none (0%-19% reduction in volume). Clinical success is defined as a complete or substantial response.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03427619
|United States, Iowa|
|Richard Smith, MD|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Richard JH Smith, MD||University of Iowa|