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Clinical Trial Information

 

  A Phase I/II Study of PG11047 in Dogs with Histiocytic Sarcoma Complex - Dr. Elisabeth Zenger, DVM, PhD

 

  Histiocytes are tissue based cells which are part of the normal immune system. There are at least 4 well defined diseases involving abnormal histiocytic proliferation recognized in dogs. These include cutaneous histiocytoma, cutaneous histiocytosis, systemic histiocytosis (SH), and histiocytic sarcoma and malignant histiocytosis (MH).


The malignant forms of canine histiocytic disease, histiocytic sarcoma and malignant histiocytosis, occur with high incidence in Bernese Mountain Dogs, Rottweilers, Flat Coated Retrievers, Golden Retrievers and sporadically in many other breeds. Histiocytic sarcomas occur as localized masses in spleen, lymph nodes, lung, bone marrow, skin and subcutis, brain, and tissue of large joints. Histiocytic sarcomas can also occur as multiple lesions in single organs (especially spleen), and rapidly disseminate to involve multiple organs. Hence, disseminated histiocytic sarcoma is difficult to distinguish from MH, which is a multi-system, rapidly progressive disease in which there is simultaneous involvement of multiple organs such as spleen, lymph nodes, lung, bone marrow, skin and subcutis. Response of histiocytic sarcomas and MH to chemotherapy is at best brief. It is vitally important that the correct diagnosis by a pathologist experienced with the full spectrum of histiocytic disease is obtained, so that it is clear which of these histiocytic diseases has occurred in a given case. Only then can the likely outcome be predicted and appropriate treatment (if one exists) instituted. More detailed descriptions with images of the individual histiocytic diseases are available at www.histiocytosis.ucdavis.edu.


Elisabeth Zenger, DVM, PhD, Dipl American College of Veterinary Internal Medicine, is conducting a funded clinical trial for dogs diagnosed with histiocytic sarcoma, disseminated histiocytic sarcoma, or malignant histiocytosis, a group of distinctive similar cancers making up the histiocytic sarcoma complex. These malignancies are often only recognized after clinical signs have appeared and the disease is advanced. Histiocytic sarcoma complex diseases generally follow a rapid (weeks to months) clinical progression to death or euthanasia. Response to available chemotherapy has been at best brief. Novel chemotherapeutics must be developed and investigated to fight these devastating diseases. PG11047 is a drug designed to be of low toxicity and an effective anticancer agent. This open label phase I/II trial examines the safety, tolerability, and efficacy of PG11047, in canine patients with naturally occurring histiocytic sarcoma complex disease. This class of drugs holds great promise for treatment of canine malignancies for which there are no other effective therapies.
 

All study procedures take place at Bay Area Veterinary Specialists, 14790 Washington Ave, San Leandro, CA. Included in the trial is cost of the drug, administration, and all monitoring. Any one interested in learning more about the trial is encouraged to contact Dr. Zenger at 510-483-7387.