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- Title
A phase I clinical study to evaluate safety of orally administered, genetically engineered Salmonella enterica serovar Typhimurium for canine osteosarcoma.
- Authors
Fritz, Sara E.; Henson, Michael S.; Greengard, Emily; Winter, Amber L.; Stuebner, Kathleen M.; Yoon, Una; Wilk, Vicki L.; Borgatti, Antonella; Augustin, Lance B.; Modiano, Jaime F.; Saltzman, Daniel A.
- Abstract
We conducted a prospective phase I study to evaluate safety of an orally administered Salmonella encoding IL-2 (Salp IL2) in combination with amputation and adjuvant doxorubicin for canine appendicular osteosarcoma. Efficacy was assessed as a secondary measure. The first dose of Salp IL2 was administered to 19 dogs on Day 0; amputation was done after 10 days with chemotherapy following 2 weeks later. Salp IL2 was administered concurrent with chemotherapy, for a total of five doses of doxorubicin and six doses of Salp IL2. There were six reportable events prior to chemotherapy, but none appeared due to Salp IL2. Dogs receiving Salp IL2 had significantly longer disease-free interval ( DFI) than a comparison group of dogs treated with doxorubicin alone. Dogs treated using lower doses of Salp IL2 also had longer DFI than dogs treated using the highest Salp IL2 dose. The data indicate that Salp IL2 is safe and well tolerated, which supports additional testing to establish the potential for Salp IL2 as a novel form of adjuvant therapy for dogs with osteosarcoma.
- Subjects
OSTEOSARCOMA in dogs; SALMONELLA enterica serovar enteritidis; TRANSGENIC organisms; DOXORUBICIN; GENETIC code
- Publication
Veterinary Medicine & Science, 2016, Vol 2, Issue 3, p179
- ISSN
2053-1095
- Publication type
Article
- DOI
10.1002/vms3.32