Clinical trial for dogs with any externally accessible malignant tumor
Evaluation of hyaluronan conjugated cisplatin localized nanoparticle therapy combined with palliative radiation therapy in dogs with naturally-occurring tumors; a phase 1 clinical trial.
Purpose and Brief Study Description:
This trial evaluates the administration and clinical response to a new conjugate of cisplatin chemotherapy administered in combination with radiation therapy in dogs with any naturally-occurring, externally-measurable malignant tumor which is not amenable to surgical resection for whatever reason.
Cisplatin is considered one of the most potent and broad spectrum chemotherapeutic agents; however, is associated with significant dose-limiting toxicities and side effects. Reformulation of cisplatin into a nanoparticle hyaluronan-conjugated cisplatin (HA-Pt) has shown promise as a safer and less toxic alternative.
- Dogs with cytologically- and/or histologically- confirmed, externally-measurable malignant tumors, not amenable to surgical resection for whatever reason, would be considered for enrollment.
- Dogs of any breed, age, gender and weighing a minimum of 10.0kg, with satisfactory health.
- Complete staging/re-staging would be required prior to study enrollment, including blood work (CBC and chemistry), urinalysis, chest radiographs or computed tomography of the thorax, and/or abdominal ultrasound or computed tomography of the abdomen.
- Prior surgery, chemotherapy, corticosteroids, NSAIDs, and/or radiation therapy is allowable if reoccurrence or progression is documented at the time of study enrollment with minimum washout periods of one month for radiation therapy, three weeks for chemotherapy, and 72 hours for NSAIDs and/or corticosteroid therapy. Concurrent chemotherapy or corticosteroids are not allowable.
What does enrollment into this trial involve?
All enrolled dogs will receive HA-Pt subcutaneously to the primary tumor on study days 0, 7, 14, and 21, at incrementally increasing doses. Within 4 hours of HA-Pt administration, enrolled dogs will also concurrently receive one fraction of radiation therapy to the tumor site (for a total of 4 factions). Blood samples will be collected immediately prior to each dose of HA-Pt and also weekly for three weeks following the final dose. After study day 42 (or sooner if your dog is removed from the study), the study will be completed and the oncology clinician will discuss additional treatment options with you.
The study will cover the costs of recheck visits up to and including study day 42. This includes physical exam, bloodwork, and urinalysis, as well as the costs of 4 doses of HA-Pt and 4 fractions of radiation therapy. The owner is responsible for the costs associated staging prior to enrollment, including the initial oncology consultation, chest x-rays, abdominal ultrasound, and computed tomography (CT) imaging.
Please contact Kris Richardson, Clinical Trials Coordinator, for more information.
Phone: (785)-532-3046; email: ClinicalTrials@vet.k-state.edu