Clinical Trials > Oncology

DSCN3255croppedClinical Research in Oncology

Currently, all the studies are open only to dogs. The below studies are grouped according to studies evaluating: 1) treatments for specific cancer types, 2) treatments for any cancer type, 3) side effects from chemotherapy, and 4) new imaging techniques (with no treatment as part of the study).

For additional information regarding any of these oncology studies, please contact Dr. Kathleen Tsimbas or members of the Oncology Service at (608) 263-7600.

1) TREATMENTS STUDIES FOR SPECIFIC CANCER TYPES

Lymphoma: Newly Diagnosed or Recurrent

This clinical trial sponsored by the National Cancer Institute (NCI) assesses the safety and effectiveness of three newly developed chemotherapy agents (indenoisoquinolines) when given to dogs with lymphoma. Studies in mice and non-tumor-bearing dogs have shown indenoisoquinolines to be safe.

The study involves intravenous administration of an indenoisoquinoline daily for 5 consecutive days. Blood samples, bone marrow biopsies, and tumor biopsies will be collected prior to treatment and following the first and fifth treatment. The first week of this study will necessitate a minimum of 2 nights, if not all, overnight boarding at the Hospital. Dogs will then return weekly for reevaluation and subsequent blood collection (Day 8, 15, 22 and 29). Continuance on study beyond day 29 will be based on response to indenoisoquinoline therapy. Costs associated with this study will be provided by the study. In the event any complications arise during the study period, their management will be covered by study funds up to $2,000/per dog/per event. This would include any unanticipated hospitalizations. In addition, a gift of $1,000 (one thousand dollars) will be credited to the owner’s UW Veterinary Care account.

Lymphoma of the skin (Cutaneous T Cell Lymphoma)

The most common type of lymphoma in dogs is multicentric, meaning it involves several lymph nodes. A less common type of lymphoma, called cutaneous T cell lymphoma (CTCL), presents as tumors in the skin. While dogs with multicentric lymphoma initially respond to currently available chemotherapy protocols, response rates are considerably lower and generally briefer in duration in patients with CTCL. We previously demonstrated the effectiveness of the novel chemotherapy agent GS-9219 in dogs with multicentric lymphoma in which 100% of newly diagnosed dogs and 60% of previously treated (with chemotherapy drugs other than GS-9219) dogs experienced anti-tumor responses. One of the observed side effects in GS-9219-treated dogs was a skin reaction characterized by redness, hair loss, and itching, implying significant delivery of GS-9219 to the skin. Given the lack of effective therapy for canine CTCL and the demonstrated anti-lymphoma activity and apparent skin accumulation of GS-9219, we are evaluating the effectiveness of GS-9219 in canine CTCL. GS-9219 will be administered as a 30-minute intravenous infusion once every 21 days. The owner will be responsible for the costs of the initial examination and tests to insure eligibility to participate (approximately $400). Costs associated with this study will be provided by the study. In addition, a gift of $500 (five hundred dollars) will be credited to the owner’s UW Veterinary Care account.

Mast Cell Tumors

Mast cell tumors (MCT) are a common skin tumor of dogs. Current treatment options available for MCT include various combinations of surgery, chemotherapy drugs such as vinblastine or lomustine, radiation therapy, and the new oral MCT drug Palladia® (toceranib). We currently have two clinical trials for dogs with MCT:

  • In the first trial, we are seeking to investigate the difference in responses of MCT with and without a mutation in KIT to Palladia and vinblastine. Vinblastine is an intravenous chemotherapy agent that is commonly used in the treatment of MCT. Palladia is an oral drug that works by inhibiting the function of a protein important for mast cell survival called KIT. Activating mutations in KIT are found in a population of MCT, and Palladia has been shown to be more effective against tumors with this mutation. Dogs with confirmed MCT, with or without lymph node involvement, may be eligible for this study. Prior surgery for MCT is acceptable, but no previous medical therapy (steroids, chemotherapy, etc.) is permitted. Upon entry, dogs will be randomized to receive either Palladia or vinblastine. The study will pay for the initial biopsy, KIT genotyping (to determine mutation status), chemistry profiles, and costs associated with treatment (Palladia or vinblastine). The owner will be responsible for the costs of the initial examination and tests to insure eligibility to participate (approximately $400), the recheck examinations, complete blood counts, and ancillary medications (diphenhydramine, omeprazole, prednisone).
  • In the second trial, we are investigating the combination of Palladia and lomustine. Dogs with confirmed MCT, with or without lymph node involvement, may be eligible for this study. Prior surgery and chemotherapy for MCT is acceptable with the exception of prior treatment with Palladia or lomustine. Dogs that have received Palladia or lomustine are not eligible for this study. All dogs will receive Palladia and lomustine. The dose of lomustine will be increased as dogs are entered into this trial so that we can determine the maximum tolerated dose of lomustine when given in combination with Palladia. The study will pay for the costs associated with treatment (Palladia and lomustine), and physical examinations and blood tests required throughout treatment. The owner will be responsible for the costs of the initial examination and tests to insure eligibility to participate (approximately $400) and ancillary medications (diphenhydramine, omeprazole, prednisone).

Nasal Tumors

Tomotherapy dose painting clinical trial for dogs with nasal tumors of adenocarcinoma histology: Conformal avoidance of eyes and brain with increased dose to regions of tumor hypoxia.

Helical TomoTherapy™ is a combination of a linear accelerator and a helical CT scanner that delivers highly precise radiation to treat tumors while avoiding critical normal tissues. This radiation therapy machine was developed at the University of Wisconsin. In a previous study the UW-SVM treated 31 dogs with nasal tumors delivering dose to the tumor while avoiding the eyes, which significantly reduced ocular toxicity. In this new study we are evaluating molecular imaging of the tumor to guide and individualize each dog’s treatment plan with the goal to prolonging overall survival. Owners are responsible for the cost of the initial staging (approximate cost $1000-1200). Owners will pay $1500 toward this state-of-the-art therapy (typical cost is $4500-5000) and owners will pay for medications.
The study will pay for the following:

  • Radiotherapy treatment with Helical TomoTherapy™ & anesthesia
  • Molecular imaging (PET/CT’s), tumor biopsy correlated with imaging, & anesthesia
  • Ophthalmic exams and CBC/serum biochemistry profile/urinalysis
  • Hospitalization during treatment and imaging

Dogs With a Malignant Mammary Tumor, Melanoma, Head and Neck Carcinoma, or Soft Tissue Sarcoma

The purpose of this study is to assess the safety and effectiveness of iniparib, a novel anticancer agent, in combination with one dose of carboplatin, when given to dogs with cancer. Iniparib has been safely evaluated in human patients with cancer and in normal, non-tumor-bearing dogs. Carboplatin is a commonly used chemotherapy drug for the treatment of cancer in dogs.

Dogs that have been diagnosed with a new or recurrent malignant mammary tumor, melanoma, head and neck carcinoma, or soft tissue sarcoma may be eligible for this study. Dogs will be excluded from this study if they have had any prior therapy for their cancer other than surgery. The study involves four intravenous administrations of iniparib over the course of 22 days and one intravenous administration of chemotherapy (carboplatin) study day 8. Tumor biopsies will be performed prior to starting treatment and then once following each iniparib treatment. Additionally, a physical examination will be performed and a blood sample will be collected prior to starting treatment and then again on study days 1, 4, 8, 11, 15 and 22. After Day 22, dogs will be off study and eligible to pursue other treatments and therapies. Costs associated with this study will be provided by the study. In the event any complications arise during the study period, their management will be covered by study funds up to $2,000/per dog/per event. This would include any unanticipated hospitalizations. In addition, a gift of $1,000 (one thousand dollars) will be credited to the owner’s UW Veterinary Care account.

2) TREATMENT STUDIES FOR ANY CANCER TYPE

Any Malignant Tumor in Dogs

Doxorubicin is an effective chemotherapy drug commonly used for the treatment of various cancers in dogs including lymphoma, hemangiosarcoma, and osteosarcoma. The lifetime dose of doxorubicin is limited due to its cardiac toxicity, which limits the long-term use of this drug. Doxil®, a doxorubicin containing liposome, has been shown to decrease cardiac toxicity, prolong drug circulation times, and enhance anticancer effects (when compared to free doxorubicin). However, unlike free doxorubicin, a skin reaction (ranging from mild redness and hair loss to severe crusting, ulceration, and peeling of the skin) termed Palmar-Plantar Erythrodysesthesia Syndrome (PPES) or hand-foot syndrome can be dose-limiting for Doxil® in both dogs and people and often prevents repeated dosing. A new formulation of a doxorubicin containing liposome, called PLDMS, has been found to have increased anticancer activity and a reduced incidence of PPES when compared to Doxil®. The purpose of this study is to determine the maximum tolerated dose in dogs and compare the incidence of PPES to dogs in a previous study that had received Doxil®.

Dogs with any measurable malignant tumor may be eligible for this study. The study involves intravenous administration of PLDMS once every 3 weeks for a total of 5 treatments. At the time of each treatment, blood and urine tests, and a skin biopsy will be performed. One week after each treatment, a blood test will be performed. The owner will be responsible for the costs of the initial examination and tests to insure eligibility to participate (approximately $400). Costs associated with this study (all treatments and follow-up examinations and procedures) will be provided by the study. In the event any drug-related complications arise during the study period, their management will be covered by study funds up to $3,000/per dog. This would include any unanticipated hospitalizations.

Any Malignant Tumor Other Than Mast Cell Tumor in Dogs

The purpose of this study is to determine the safety, efficacy, and maximum tolerated dose of CCNU (lomustine) when given in combination with toceranib (Palladia) in tumor-bearing dogs (other than mast cell tumors). Prior surgery and chemotherapy is acceptable with the exception of prior treatment with toceranib or CCNU. Dogs that have received toceranib or CCNU are not eligible for this study. All dogs will receive toceranib, CCNU, and denamarin (a drug which protects the liver from potential side effects that have been associated with CCNU). The dose of CCNU will be increased as dogs are entered into this trial so that we can determine the maximum tolerated dose of CCNU when given in combination with toceranib. The study will pay for the toceranib, CCNU, and denamarin. The owner will be responsible for all other costs, including physical examinations and blood tests.

3) STUDIES EVALUATING CHEMOTHERAPY SIDE EFFECTS

Dogs: Incidence of bacterial infections in febrile and afebrile neutropenic patients undergoing chemotherapy

Inclusion criteria: For this prospective observational study, we are enrolling current canine chemotherapy patients with <1500 neutrophils/uL.

The purpose is to evaluate the culture isolates from neutropenic febrile and non-febrile canine chemotherapy patients.

The study will cover the cost of the blood cultures (two sets), urine culture, complete urinalysis, and ultrasound-guided cystocentesis charge.

Following owner consent for enrollment in the study, we will collect blood culture and sensitivity samples (aerobic and anaerobic) from two separate sites and a urine sample for complete urinalysis and urine culture and sensitivity. We will be using ultrasound-guidance to obtain urine via cystocentesis; when there is a contraindication to cystocentesis (thrombocytopenia or previously diagnosed urinary bladder neoplasia), we will collect a midstream voided urine sample.

Exclusion criteria: Previous enrollment in this study OR Packed Cell Volume (PCV) <20%.

Please contact Dr. Jonathan Bach if you have any questions about the study or study enrollment 608-263-7600.

4) IMAGING OR BIOPSY STUDIES

Any Malignant Tumor in Dogs

Computerized tomography (CT) is a commonly used diagnostic tool that provides information regarding the presence of tumors often too small to detect using conventional X-rays. Contrast agents that preferentially bind to tumors are often administered just prior to a CT scan to further enhance the chance of detecting a tumor. One of the limitations of currently used contrast agents is their short half-life, disappearing from the body within hours of administration. A contrast agent that remains in the body longer (for several days without adverse effects) would allow for the performance of multiple CT scans over time, which could provide valuable information regarding the effectiveness of anticancer treatments. The purpose of this study is to evaluate a novel imaging agent that has a half-life of at least 24 hours, allowing for the performance of multiple CT scans over time following a single injection, and has been found to provide greater resolution of the CT images which may increase the ability to detect tumors at an earlier stage of development. This is extremely important with regard to the ability to detect metastatic lesions in patients diagnosed with cancer and for the evaluation of the effect of their cancer treatment.

Dogs with any metastatic malignant tumor for which the owner has elected treatment or euthanasia may be eligible for this study. The study involves the performance of three CT scans; one prior to administration of the contrast agent, and then again at one and 24 hours after intravenous administration of the contrast agent. The study will cover all costs associated with the performance of the CT scans, and in addition, $1,000 will be credited to the owner’s UW Veterinary Care account if the dog will be undergoing treatment or $500 will be credited to the owner’s UW Veterinary Care account if the dog will be euthanized following completion of the CT scans.

Offset the Cost of Biopsy for Dogs With Melanoma or Primary Lung Tumor

We were one of the first three centers nationally (there are now seven to become a cancer tissue procurement center for the Canine Comparative Oncology and Genomics Consortium (CCOGC), a group of veterinary and medical researchers who have determined that a well-described repository of canine tumor tissues is an essential resource to progress new cancer therapies. This new resource to fight cancer has been named the Pfizer Inc. CCOGC Biospecimen Repository (www.ccogc.net). The cost of surgical biopsy collection, a necessary diagnostic step in the majority of patient work-ups, is completely covered in most cases (unless involving open cavity collection).

For additional information regarding any of these oncology studies, please contact Dr. Kathleen Tsimbas or members of the Oncology Service at (608) 263-7600.