Clinical trial for dogs with externally accessible malignant tumor
Evaluation of locally-delivered nanotherapy cisplatin in combination with radiation therapy in dogs with any malignant tumor.
Purpose and Brief Study Description:
This trial evaluates the administration and clinical response to a new conjugate of cisplatin chemotherapy, administered in combination with palliative 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 side effects. This reformulation of cisplatin into a nanoparticle conjugate has shown promise as a safer, less toxic and efficacious alternative.
- Dogs with any cytologically- and/or histologically- confirmed, externally-measurable malignant tumor(s), 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 a satisfactory health score.
- Complete staging/re-staging would be required prior to study enrollment, including blood work (CBC and chemistry), urinalysis, thoracic radiographs or computed tomography of the thorax, and/or abdominal ultrasound or computed tomography of the abdomen.
- Prior surgery, chemotherapy (excluding a platinum agent), 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, corticosteroids and/or radiation therapy are not allowable.
What does enrollment into this trial involve?
Enrolled dogs will be assigned to one of two study arms according to the owners' preference. One arm will receive only the cisplatin conjugate, and the second arm will receive the cisplatin conjugate in combination with radiation therapy. All enrolled dogs will receive the cisplatin conjugate administered directly into the primary tumor on study days 0, 7, 14, and 21, at incrementally increasing doses. The dogs enrolled in the second arm will also concurrently receive four fractions (doses) of radiation therapy to the tumor site once a week, for four weeks. Blood samples will be collected immediately prior to each dose of the cisplatin conjugate and also weekly for three weeks following the final dose. After study day 42 (or sooner if a dog is removed from the study), the study will be completed and the oncology clinician will discuss additional treatment options and/or ongoing monitoring with the owner.
Study funds currently cover the cost of the cisplatin conjugate nanotherapy.
Please contact Misty Bear, Clinical Trials Coordinator, for more information. Phone: (785)532-3046; email: ClinicalTrials@vet.k-state.edu