Oncology

Below, please find links to all of the clinical trials involving cancer (oncology). The studies include a multitude of information, including (but not limited to) the study’s purpose, benefits for participating, and financial incentive information. If you have any questions, please contact the individual outlined at the end of each trial summary.

Please visit the Oncology service webpage at the Veterinary Medical Teaching Hospital (VMTH) or the Comparative Cancer Center (CCC) if you would like to learn more about the amazing things that our oncologists can do for you and your animal.  

If you have any questions that are specific to oncology for any species, please contact our Oncology Clinical Trial Coordinator, Teri Guerrero, at tguerrero@ucdavis.edu or (530) 752-0125.

Cats

Bone, kidney, head/neck, and adrenal gland cancer: Using Cryoablation at the VMTH

Title: Tumor Cryoablation at the UC Davis Veterinary Medical Teaching Hospital

Purpose of Study: The diagnostic and treatment options available in veterinary medicine are advancing rapidly, and we now have the opportunity to perform many of the high-level techniques that are commonly performed in human medicine. A procedure that has gained acceptance in human medicine but is currently developing in veterinary medicine is cryoablation. Cryoablation involves killing cancerous tissue by freezing. In humans it is used most commonly for the treatment of prostatic cancer and kidney cancer, although it has also been used for the treatment of bone cancer, liver cancer, lung cancer, and other soft tissue cancers.

Unlike peripheral cryoablation, which usually involves applying liquid nitrogen to a skin lesion, when performing percutaneous cryoablation large needles are placed into the affected tissue to administer the freeze – this is done either under direct visualization (surgery) or through tiny skin incisions but under the guidance of an imaging device (most commonly CT or ultrasound), allowing treatment of deep internal lesions. This procedure has been rarely reported in veterinary medicine but is offered by the UC Davis Veterinary Medical Teaching Hospital.

Participation Requirements: To be discussed on a case-by-case basis with Dr. Steffey

Initial Evaluation for Participation: To be discussed on a case-by-case basis with Dr. Steffey

Procedures: At a minimum, a small incision or incisions may be required under general anesthesia. Depending on the tumor location, open surgery or minimally invasive surgery for visualization/retraction of other organs may be needed. The treated tissue will die and be “cleaned up” by the body’s immune system. If discomfort following the surgery occurs, pain management will be provided. Your cat will need to be monitored closely post-cryoablation.

Benefits: If the procedure is unable to be performed, the costs of anesthesia and equipment will still need to be considered.

Owner Responsibilities: None.

Contact: Contact the scheduling coordinators in Soft Tissue Surgery (530) 752-1393 for Dr. Steffey's study.

Squamous Cell Carcinoma (Oral): Tumor Collection

Title: Oral Squamous Cell Carcinoma Repository study

Purpose of Study: UC Davis is collecting oral Squamous Cell Carcinoma samples to populate a tissue bank for future research studies.

Participation Requirements: Cats with confirmed diagnosis of oral Squamous Cell Carcinoma.

Initial Evaluation for Participation: Cats with a confirmed diagnosis of oral malignant melanoma

Procedures: After receiving consent from owners, a sample of the tumor is banked at the time of your cat's visit.

Benefits: There is no cost to the owner for participation in this study. The samples collected will be stored for future use of investigators with the ultimate goal of developing a treatment and prevention for the variety of cancers.

Owner Responsibilities: The owner only needs to consent to the sample being collected at the time of your cat's visit.

Contact: Please talk to your oncologist at the time of your cat's visit.

Dogs

Anal Sac Gland Carcinoma: Using CT Lymphography to Assess Lymphatic Center

Title: Assessment of the iliosacral lymphatic center in dogs with anal sac gland carcinoma using indirect computed tomographic lymphography

Purpose of Study: Anal sac gland cancer is a locally aggressive cancer that has high rates of metastasis or spread through the regional lymph nodes. The use of surgery, chemotherapy and possible radiation therapy is recommended for patients with confirmed metastatic disease. Even when metastatic disease is present, reasonable survival rates have been achieved with aggressive treatment. The current gold standard for evaluation of lymph node metastasis in this disease is abdominal ultrasound of lymph nodes in the abdomen, however this technique misses lymph nodes in the pelvis that are actually closer to the primary tumor. We will evaluate the effectiveness of CT to evaluate the entire draining lymph node center in dogs with this cancer.

Participation Requirements: Dogs with an anal sac tumor that has not been surgically removed.

Initial Evaluation for Participation: Dogs must be evaluated by the UCDavis Veterinary Medical Teaching Hospital (VMTH) Soft Tissue Surgery or Medical Oncology Services and have an abdominal ultrasound performed by the UCDavis VMTH Radiology Service as part of normal pre-operative assessment for their dog’s disease.

Procedures: In addition to the standard contrast CT scans used to evaluate tumors and lymph nodes, a CT will be performed in which a small amount of contrast material will be injected subcutaneously (under the skin) very close to the primary tumor, which will help to highlight the lymphatic drainage of the region and identify the nearest lymph node to the tumor.

Benefits: The results of the CT evaluation will help determine the extent of additional disease (if present) in your dog. The CT will provide information that may improve our ability to make surgical recommendations for your dog. If disease is present in other lymph nodes that is not surgically removable for whatever reason, these procedures will still benefit your dog, as we will be able to make better post-surgical treatment recommendations, such as possible need for chemotherapy and/or radiation therapy. Costs associated with the CT scans, including the imaging and contrast material, will be covered by the study.

Owner Responsibilities: The owner is responsible for standard costs of their dog’s care (surgical removal of the primary tumor removal and any lymph nodes if so desired by the client), other pre-operative diagnostics deemed medically necessary, histopathologic analysis, hospitalization, and management of any standard surgical complications that may occur.

Contact: Call (530) 752-1393 to talk to the Specialty Coordinators or Technicians in Soft Tissue Surgery about Dr. Steffey's study.

Brain Tumors: Investigating Therapy Delivery Methods

Title: Convection enhanced delivery (CED) of murine leukemia virus (MLV) cytosine deaminase (CD) gene therapy in canine glioma

Purpose of Study: This clinical trial will investigate the delivery of a viral gene therapy for canine gliomas (brain tumors).

Participation Requirements:

  • Dogs with intracranial glioma
  • Ineligible:
    • Moderate or severe neurological deficits
    • Uncontrolled seizures
    • Rapidly deteriorating neurological status

Initial Evaluation for Participation: Dogs will be assessed for eligibility based on an MRI scan. A CT guided brain biopsy will be done to confirm the diagnosis and to concurrently deliver the gene therapy.

Procedures: Using CT and MRI scans, a needle will be placed into the brain tumor (previously diagnosed on MRI). A biopsy of the tumor will be taken and the viral gene therapy will be injected into the tumor through the same needle. 2-4 weeks following the injection, the tumor will be surgically removed or be bulked. Following surgery, further treatment may include radiation therapy and/or the experimental gene therapy drugs.

Benefits: The major benefit for the dog and owner is that the brain biopsy, surgery, radiation therapy and experimental gene therapy will be paid for up to an initial cost of $20,000 per case.

Surgical resection and radiation therapy are the standard of care treatment at this time for gliomas. Based on individual case assessment, the experimental gene therapy may be given and may have an additional benefit in treating any recurrent or residual tumor.

Owner Responsibilities: Owners are responsible for the small costs associated with any routine medications that the dog is currently prescribed. Treatment will be assessed based on recheck MRI scans at 2-3 month intervals.

Contact: Owners or referring veterinarians should contact the Neurology/Neurosurgery coordinator, Christy Chessman, at (530) 754-0606 or cchessman@vmth.ucdavis.edu.

Bone cancer: Examining Metastasis Suppressor Drug

Title: Thiomolybdate as a Suppressor of Canine Osteosarcoma Metastasis

Purpose of Study: The purpose of this clinical trial is to evaluate the possibility of using a copper-inhibiting drug (tetrathiomolybdate, TM) to limit the spread of bone cancer (osteosarcoma) to other areas of the body. This medication may ultimately lead to improved treatment outcomes for both dog and human cancer patients.

Participation Requirements: Dogs following amputation of the primary bone tumor

Initial Evaluation of Participation: None.

Procedures:

  • Dogs will receive a standard-of-care treatment (IV Carboplatin every 3 weeks for four treatments) concurrently with either the test compound or a placebo pill. Dogs will be randomized to receive the test compound or placebo in a 1:1 ratio (equal chances of being assigned to either group). The oral treatments will be given 3 times daily, with the morning and evening doses given without food while the mid-day dose will be given with a meal. A blood sample of approximately 1-2 tablespoons will be taken from your dog on a weekly basis for 2-6 weeks and analyzed for levels of copper and a copper-carrying compound. A complete blood count and serum chemistry panel will also be performed to monitor for any potential side effects. Based on the copper levels, we will adjust the drug dose to minimize any side effects, which include anemia and (very rarely) nausea in the early phases of treatment.
    • Nausea is managed by the addition of an anti-vomiting medicine if needed.
    • Anemia is managed by discontinuing the compound until the blood count returns to normal, and then resuming treatment with a lower dose of the compound.
  • After the initial 2-6 week period, your dog will be monitored by monthly physical examinations and blood tests, supplemented by chest X-rays every 3 months to check for tumors in the lung (the most common site of metastasis). Monitoring will continue until metastasis is detected or for 1 year from the start of study. At the end of the study, dogs will have an abdominal ultrasound.
  • Dogs that benefit from the drug (i.e., no evidence of metastasis at 1 year or lung tumors that shrink or are stable) may continue to take the compound after the end of the study for up to 6 additional months. Dogs with cancer that spreads that were assigned to the placebo group can be transferred to the test drug at that time. Such dogs may continue to be monitored for evidence of stabilization or shrinkage of tumors for at least 6 months, unless further tumor growth is detected.

Benefits: While the exact benefits are not entirely known, these procedures may help treat your dog's cancer.

Owner Responsibilities: Partial costs associated with this study will be compensated as part of your participation. The study drug (or placebo), monthly radiographs (including appointment recheck fees), and any necessary additional blood tests are all covered by the study. You will be responsible for all other costs including routine chemotherapy costs, routine blood tests, and any costs associated with treatment of adverse effects. Carboplatin treatments usually cost somewhere between $200-300 per treatment (depending on the size of your dog and whether blood tests are necessary). Therefore, the cost to you for participating in this study is expected to be approximately $1500-$2000 in the absence of side effects.

Contact: Teri Guerrero (530-752-0125 or tguerrero@ucdavis.edu)

Bone, Kidney, Head/Neck and Adrenal Gland Cancers: Cryoablation at the VMTH

Title: Tumor Cryoablation at the UC Davis Veterinary Medical Teaching Hospital

Purpose of Study: The diagnostic and treatment options available in veterinary medicine are advancing rapidly, and we now have the opportunity to perform many of the high-level techniques that are commonly performed in human medicine. A procedure that has gained acceptance in human medicine but is currently developing in veterinary medicine is cryoablation. Cryoablation involves killing cancerous tissue by freezing. In humans it is used most commonly for the treatment of prostatic cancer and kidney cancer, although it has also been used for the treatment of bone cancer, liver cancer, lung cancer, and other soft tissue cancers.

Unlike peripheral cryoablation, which usually involves applying liquid nitrogen to a skin lesion, when performing percutaneous cryoablation large needles are placed into the affected tissue to administer the freeze – this is done either under direct visualization (surgery) or through tiny skin incisions but under the guidance of an imaging device (most commonly CT or ultrasound), allowing treatment of deep internal lesions. This procedure has been rarely reported in veterinary medicine but is offered by the UC Davis Veterinary Medical Teaching Hospital.

Participation Requirements: To be discussed on a case-by-case basis with Dr. Steffey

Initial Evaluation for Participation: To be discussed on a case-by-case basis with Dr. Steffey

Procedures: At a minimum, a small incision or incisions may be required under general anesthesia. Depending on the tumor location, open surgery or minimally invasive surgery for visualization/retraction of other organs may be needed. The treated tissue will die and be “cleaned up” by the body’s immune system. If discomfort following the surgery occurs, pain management will be provided. Your dog will need to be monitored closely post-cryoablation.

Benefits: This technique is considered to be more minimally invasive compared to standard techniques.

Owner Responsibilities: If the procedure is unable to be performed, the costs of anesthesia and equipment will still need to be considered.

Contact: Contact the scheduling coordinators in Soft Tissue Surgery (530) 752-1393 for Dr. Steffey's study.

Gastrointestinal (Colon & Rectum) Cancer: Evaluating New Diagnostic Tool

Title: Evaluation of CT pneumocolonography as a diagnostic tool in veterinary patients

Purpose of Study: The purpose of this study is to evaluate the impact of imaging findings on surgical decision-making in dogs with colonic and rectal disease of any kind (cancer or non-cancer). This part of the body can be a very difficult region examine with current imaging methods, which also do not provide optimal spatial information important if a surgical procedure is needed. In early studies, we have demonstrated the safety and efficacy of the CT pneumocolonography procedure in normal dogs, but it is important that we learn to accurately interpret the imaging findings for a wide variety of disease processes in clinical patients so that our CT diagnoses are accurate. Our goal is to compare the imaging findings obtained with CT pneumocolonography with the current standard of care of colonoscopy and colonoscopic biopsies.

Participation Requirements: In order to participate in this study, a colonoscopic exam must have been recommended for workup of your dog’s problem, and your dog must be scheduled to receive a colonoscopic exam under general anesthesia at UC Davis.

Initial Evaluation for Participation: None.

Procedures: If you agree to participate, your dog will receive a CT scan (with and without intravenous contrast material) in conjunction with carbon dioxide gas insufflated into the rectal lumen. Following CT pneumocolonography, your dog will receive the scheduled colonoscopy, which is the current standard of care for assessment of these masses, and if clinically indicated for the care of your dog, biopsies will be obtained.

Benefits: In return for participation in this study, your dog will receive a free CT scan (an approximately $800 value to you), which may directly benefit your dog, as it can provide important information for treatment recommendations that other types of imaging cannot. CT evaluation of local lymph nodes is an additional benefit as CT has been demonstrated to be helpful in the evaluation of regional lymph nodes for metastatic disease in other types of cancer in other locations.

Owner Responsibilities: There is no additional cost to you for your dog’s participation in the study. You are financially responsible for hospital costs associated with the standard care of your dog, including abdominal ultrasound, general anesthesia, colonoscopy, hospitalization, biopsies, and any other diagnostic tests recommended for evaluation of your dog’s disease by your attending clinician.

Contact: Call 530-752-1393 for Drs. Michele Steffey and Stanley Marks's study

Histiocytic Sarcoma: Evaluating a Chemotherapeutic Agent as a Treatment Option

Title: Phase II evaluation of vinblastine for the treatment of canine histiocytic sarcoma

Purpose of Study: Histiocytic sarcoma (HS) is a common and aggressive cancer in dogs that can arise from many sites including the lymph nodes, liver, spleen, lungs, or bone. If left untreated, disease progression is often rapid with a devastatingly high mortality rate. CCNU (Lomustine) is currently the only chemotherapy agent proven to be effective against this cancer; however, responses are often short-lived. In addition, CCNU may cause liver or bone marrow toxicity with continued use and is not tolerated in some patients. Thus, there is a desperate need to identify alternative agents that are effective against this disease. Vinblastine is a commonly used chemotherapeutic agent in dogs and is proven to be relatively safe and effective against other cancers, such as lymphoma and mast cell tumors. The purpose of this study is to determine whether vinblastine may have activity against canine histiocytic sarcoma.

Participation Requirements: Dogs diagnosed with histiocytic sarcoma

Initial Evaluation for Participation: None.

Procedures: Dogs will receive weekly vinblastine chemotherapy (given intravenously) at a standard starting dose with the intent to gradually increase this dose if it is well tolerated. Blood will be drawn before each dose to make sure it is safe to treat your dog that day. After 4 total doses, tumor lesions will be measured and response to vinblastine chemotherapy will be determined using standard criteria. If this measurement requires chest x-rays or ultrasound, those tests will be run at this time. After 4 doses, your dog will be considered “off-study”; however, you may choose to continue treatment with vinblastine if your dog has responded well to treatment.

Benefits: There is a $250 financial incentive meant to help cover the cost of repeat testing necessary to measure response to vinblastine treatment (required after 4 doses) or toward the costs of study treatments. Additionally, participation in this study could help treat your dog’s histiocytic sarcoma and advance veterinary medicine.

Owner Responsibilities: Owners are responsible for pre-enrollment bloodwork (CBC and chemistry screen) to determine eligibility, all costs of vinblastine treatment (drug and administration costs), cost associated with any side effects that may occur, and costs associated with non-study related medical conditions.

Contact: Teri Guerrero (530-752-0125 or tguerrero@ucdavis.edu)

Lung Tumors: Finding a Treatment

Title: Evaluation of Liposomal Curcumin in Dogs

Purpose of Study: Curcumin has been shown to demonstrate antitumor effects against a variety of tumors in the laboratory; however, reaching anti-tumor levels of curcumin in clinical patients has proven challenging. Liposomal curcumin was developed to overcome this challenge, and is currently undergoing clinical investigation.

Participation Requirements: Dogs diagnosed with a lung tumor greater than 2cm in size (primary or metastatic). Additional eligibility/exclusion criteria apply. 

Initial Evaluation for Participation: None.

Procedures: Your dog will receive an infusion of liposomal curcumin once a week for four weeks. For each infusion, a catheter will be placed in one of the leg veins and your dog will receive an infusion of liposomal curcumin over 8 hours. We will collect a weekly blood sample as is standard for patients undergoing chemotherapy. Please note that the appointment and treatment will take all day.

Benefits: The study will cover the liposomal curcumin, blood tests, appointment fees, and administration fees. Additionally, the study will cover up to $1000 for any adverse events associated with the drug treatment (not related to the cancer); however; adverse events can only be covered for treatment received at the VMTH, so we are unable to provide payment for care required by veterinary care outside of the VMTH. The study will not cover unrelated medications your pet is receiving such as pain medications or other. Imaging (x-rays) is required to obtain tumor measurements, and the study will not be able to pay for these tests; therefore, the owner will be responsible for imaging costs needed to evaluate tumor response. This study will require imaging to be performed prior to enrollment and up to every 2 weeks during the study. Imaging costs can vary between $185-250 each time. Please ask your oncologist to clarify anticipated costs.

We cannot promise any benefits to your dog or other animals from your taking part in this clinical trial; however, we are hopeful that this drug may slow down or shrink tumors in dogs.

Owner Responsibilities: If you allow your dog to participate in this study, you will be responsible for making and keeping all appointments to the best of your ability. Appointment fees and tests to determine eligibility as well as imaging costs are the responsibility of the owner. Additionally, you are also responsible for contacting the investigators if any potential adverse events are noted.

Contact: Teri Guerrero (530-752-0125 or tguerrero@ucdavis.edu)

Lymphoma: Evaluating Drug Candidates

Title: COTC007b: Preclinical Comparison of Three Indenoisoquinolines Candidates in Tumor-Bearing Dogs

Purpose of Study: 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. Although this class of compounds has shown efficacy in a variety of cancers, interest in developing new topoisomerase I inhibitors, indenoisoquinolines, are currently being evaluated in human patients as agents with improved drug stability and measurable blood levels. This study will be the first time the indenoisoquinolines are being assessed in dogs with cancer.

The trial described below is divided into 2 phases of which your dog will be involved in one. It includes a dose finding phase for safety and a validation phase for biological assay development (tumor marker evaluation pre and post treatment). Anti-cancer activity against canine lymphoma will be assessed in both phases.

Participation Requirements: Dogs with confirmed diagnosis of lymphoma with at least two lymph nodes larger than 3 cm diameter are eligible to participate. Dogs may be newly diagnosed or have previously received treatment. A two-week washout period from previous chemotherapy or radiation therapy is required and dogs must not have received corticosteroids or L-asparaginase seven days prior to entry into the study. Dogs must be feeling well and otherwise good overall health with adequate organ function as determined by recent blood work to participate in this study.

Initial Evaluation for Participation: During the initial consultation, we will complete a physical examination, collect blood and urine samples and perform chest x-rays to confirm eligibility.

Procedures: The trial procedures include the following:

  • During the initial consultation, we will complete a physical examination, collect blood and urine samples and perform chest x-rays to confirm eligibility.
  • The first week of therapy will require overnight boarding at the VMTH for up to 7 days (6 nights). Prior to enrollment, your attending clinician will determine the required number of nights your dog will need to board at the VMTH.
  • Biopsies of your dogs’ tumors (lymph nodes) will be required prior to treatment (Day -1) and then after treatment on the 1st (two time points) and 6th (one time point) days after treatment begins. Samples of bone marrow will also be collected at two time points, one as a baseline on Day -1 and the other on Day 6 after the 5-day treatment period. Each of these biopsy sessions will occur under anesthesia, either local (sedation with anesthetic) or general.
  • You will need to bring your dog in weekly for re-evaluation and subsequent blood draws (Day 8, 15, 22 and 29). Continuance on study beyond Day 29 will be based on clinical response to indenoisoquinoline therapy. All of these visits are required for inclusion in the study.

Benefits: Clients participating in this study will be given special financial considerations. Once enrolled in the study, all costs associated with this study will be covered. In the event any complications arise during the study period, their management will be covered by study funds up to $2000/per dog/per event. This would include any unanticipated hospitalizations. Once the study has been completed, a $1000 credit will be applied to your dog’s account at the VMTH that can be used for further treatment.

The benefit to your dog associated with this treatment is not known and toxicity is possible; however, possible benefits include future studies in dogs with cancer, as well as humans with cancer, will be in part based on information gained in this trial.

Owner Responsibilities: Owners are responsible for the cost associated with the diagnosis of the pet’s cancer as well as the cost of the initial consultation with the oncology service and blood work and urinalysis to determine eligibility. Owners are expected to make and keep all appointments, according to the clinical trial protocol.

Contact: Teri Guerrero (530-752-0125 or tguerrero@ucdavis.edu)

Lymphoma (B-cell): Understanding the Effect of a Lymphoma Treatment on Cardiac Arrhythmias

Title: The Effect of IV Infusion of Doxorubicin on the Incidence of Cardiac Arrhythmias and Cardiac Troponin I Levels in Dogs

Purpose of Study: Doxorubicin is currently the mainstay of treatment for dogs with B-cell lymphoma. This drug is known to be toxic to cardiac muscle cells; however, this toxicity is unavoidable, as the drug is so critically important in treatment of the disease. Currently, the only method for monitoring this toxic effect is echocardiography, which is expensive and only able to identify toxic changes once they become severe. The aim of this study is to determine whether monitoring of arrhythmia or blood markers of cardiac cell death can provide an early warning system for detecting the toxic effects of the drug.

Participation Requirements:

  • Ineligible:
    • Evidence of pre-existing cardiomyopathy
    • Previous history of arrhythmia
    • Currently receiving anti-arrhythmic therapy
    • Previous history of thoracic radiation therapy

Initial Evaluation for Participation: B-cell lymphoma must be diagnosed at UC Davis.

Procedures: Once your dog has been diagnosed with lymphoma and is undergoing treatment with chemotherapy including doxorubicin, the dog will need to have a heart ultrasound (echocardiography), heart rhythm monitoring with a Holter monitor, and blood sample collected before treatment with doxorubicin and at each doxorubicin treatment. Approximately 1-2 tbsp of blood will be taken at your dog's appointment after doxorubicin treatment for the Troponin test. This testing will occur around the same time as each dose of doxorubicin. Heart rhythm monitoring will be collected for 24 hours after some visits (i.e., your dog will go home wearing the monitor) and for only 1 hour in the hospital at other visits. Holter monitoring provides a continuous recording of the heart rhythm during your dog's normal activity. The monitor is worn for 24 hours. Five electrodes (small conducting patches) are placed on the chest. We need to shave the skin to connect each corresponding electrode.  Once attached to the cables, electrodes will be taped onto the chest and attached to a small battery-operated recording monitor. Your dog will be fitted with a vest and the monitor carried in the pocket.

Benefits: Your dog will receive free screening for a heart condition at the beginning of the study at no cost to you and you will be informed of any abnormal findings. These results may be used to adjust the chemotherapy plan and/or recommend future monitoring of your dog. The findings of this study, if validated, may used to help improve the safety and monitoring during treatment for future patients receiving doxorubicin.

Owner Responsibilities: The owner is responsible for paying for all costs associated with the diagnosis and treatment of B-cell lymphoma ($5000-6000). Assessment and monitoring costs of the echocardiograph, arrhythmia (via Holter) and any cardiac cellular damage as will be paid for by the study (~$1200). The owner will also be responsible for repair or replacement of the monitor or cables if damaged by water or sharp objects, respectively.

Contact: Teri Guerrero (530-752-0125 or tguerrero@ucdavis.edu)

Lymphoma (B or T cell): Assessing Long-term Benefits of a Combination of Medications

Title: Open-Label, Phase-2 Trial of VDC-1101 Plus Prednisone in Dogs with Lymphoma *TEMPORARILY ON HOLD*

Purpose of Study: Lymphoma, the most common hematopoietic tumor of dogs, is an aggressive disease. Although studies in dogs with lymphoma have demonstrated the safety and efficacy of VDC-1101, a limited number of dogs have been treated once every three weeks. Furthermore, anecdotal reports suggest reduction in the incidence and severity of adverse effects when used with concurrent low-dose corticosteroid therapy. For this reason, clinical evaluation of VDC-1101 given once every 21 days with concurrent low-dose prednisone will be performed in dogs with lymphoma.

Participation Requirements: Dogs diagnosed with B or T-cell lymphoma (Please note that the study is no longer accepting patients with relapsed lymphoma).

Initial Evaluation for Participation: During the initial consultation, we will complete a physical examination, take chest x-rays, and collect blood and urine samples to confirm eligibility.  A diagnosis of B or T-cell lymphoma is required.

Procedures: If your dog qualifies and you choose to enroll your dog in the study, the procedures will go as follows:

  • Day 0: We will administer the first dose of VDC-1101. Additional tests are not required as long as pre-enrollment blood tests/urinalysis are performed within 7 days.
  • Day 7: We will collect a blood sample.
  • Day 21: We will collect a blood and urine sample and administer the next dose of VDC-1101 as long as the disease has not progressed and there were no dose-limiting toxicities.
  • Day 28: This visit is only required if your dog has experienced dose limiting toxicity following the first treatment.
  • Day 42: We will collect a blood and urine sample and administer the next dose of VDC-1101 as long as the disease has not progressed and there were no dose-limiting toxicities.
  • Follow-up visits will be performed every 3 weeks as long as the disease does not progress. We will collect blood and urine samples at each treatment visit. If your dog is doing well and the disease has not progressed, your dog will receive a total of 5 treatments or 2 treatments beyond achievement of complete response (whichever is greater) followed by monthly rechecks for physical exams. Dogs with a stable disease or a partial response will receive a total of 5 treatments.
  • Chest x-rays will be recommended for all dogs at the time of the last dose and then every 2 months thereafter.

Benefits: This drug is being offered for compassionate use at a select few institutions. This study is not a funded clinical trial; however, the drug is being provided at no cost.

Owner Responsibilities: If you choose to enroll your dog in this trial, the drug will be supplied at no charge. You will, however, be responsible for all other costs including appointments, drug administration, blood and urine tests, chest x-rays, and any additional medications or treatments for side effects. You will also be responsible for scheduling and keeping the appointments as required by the protocol.

Contact: Teri Guerrero (530-752-0125 or tguerrero@ucdavis.edu)

Malignant Melanoma (Oral): Tumor Collection

Title: Pfizer-CCOGC Biospecimen Repository study

Purpose of Study: UC Davis in collaboration with Pfizer-CCOGC Biospecimen Repository is collecting samples to populate a tissue bank for future research studies. The goal of the CCOGC and UC Davis will be to populate the Pfizer-CCOGC Biospecimen Repository with diseased tissues and specific normal tissues from dogs with cancer over the next three years. The study is guided by the National Cancer Institute (NCI).

Participation Requirements:

  • Owner consent to allow collection of the clinical specimens and to comply with follow-up and treatment requirements
  • General clinical evaluation, including medical history, physical exam, complete blood count, biochemical profile, and urinalysis
  • Histological diagnosis
  • Complete staging evaluation, to include cytology or histology of submandibular lymph nodes, thoracic radiographs
  • Histology of primary site

Initial Evaluation for Participation: Dogs with a confirmed diagnosis of oral malignant melanoma

Procedures: After receiving consent from owners, a sample of the tumor is banked following the CCOGC criteria.

Benefits: There is no cost to the owner for participation in this study. The samples collected will be stored for future use of investigators with the ultimate goal of developing a treatment and prevention for the variety of cancers.

Owner Responsibilities: The owner only needs to consent to the sample being collected at the time of the visit.

Contact: Please talk to your oncologist at the time of your visit.

Nasal cancer: Evaluating Cryoablation as a Treatment Option

Title: Transnare Cryoablation of Nasal Tumors

Purpose of Study: The objective of this study is to evaluate alternative treatment options for patients with nasal tumors. Radiation therapy is still considered the gold standard of treatment for this disease, however clients who do not wish to pursue radiation therapy may be eligible for participation in this study.

Participation Requirements:

  • Inclusion Criteria:
    • Confirmed diagnosis via cytology or histopathology
    • CT scan demonstrating the extent of the nasal mass to determine if this treatment may be safely administered.  It is preferable if this test is performed at the VMTH, as not all CT scans are performed in the same way.  If we are able to perform assessment/treatment planning from a CT scan performed elsewhere, we are happy to do so, but if the CT does not allow us to evaluate what we need to in order to feel that your dog is safe for the procedure, a repeat CT scan performed at UC Davis may be necessary to be considered for the procedure.
    • CBC, Chemistry Panel and Urinalysis all within two weeks of enrollment (referring blood work is acceptable as long as it was performed at a commercial lab)
    • Owners agree to fill out cryoablation study survey forms and update UC Davis regarding their dog's outcome.
  • Exclusion Criteria
    • Dogs that have disease that invades the cribriform plate, or is otherwise too extensive to treat safely with cryoablation.
    • Dogs that have pre-existing kidney disease that would exclude the use of radiographic contrast agents during the CT scan.

Initial Evaluation for Participation: All dogs must be examined by a VMTH oncology, internal medicine, radiation oncology service or soft tissue surgery veterinarian, and require the baseline evaluations described above at the owners expense before a dog can be considered for enrollment in the trial.

Procedures: Cryoablation procedure is a minimally invasive procedure performed under general anesthesia. Special cryoablation needles are inserted through the nostrils, and freezing sufficient to kill the tumor is applied.  The needle is placed minimally-invasively through the nostrils, with no surgical incision, and the treatment is monitored via CT.  This is generally a single treatment, and the hospital stay for the average dog receiving this procedure is usually 2 nights.  

INFORMATION FOR OWNERS: Accrual for the initially funded study has been completed and we are in the process of obtaining long-term outcome information.  However, because the initial treatment responses have been good, and because of continued interest from owners, Dr. Steffey is comtinuing to offer this procedure as a treatment option through the UC Davis Veterinary Medical Teaching Hospital (VMTH).  While we are pleased with the initial responses, owners must be aware that this treatment is still considered experimental at this time, and we do not yet have outcome statistics on complications and long-term survival.  Dogs will usually have worsening nasal discharge and/or intermittent bloody noses in the 2-4 weeks after the procedure, and may even sneeze out chunks of tissue, as the tumor dies back.  They will never have a normal nasal cavity as the tumor has destroyed much of the internal structure of the nose that is responsible for humidifying/warming the air we breath, so when the tumor is removed, they may be prone to chronic nasal discharge and/or nosebleeds.  In concept, this is likely similar to visiting a cold/high-altitude northern environment in winter.  They may also be more prone to intermittent secondary infections (bacterial/fungal) for the rest of their lives, although we do not yet have long-term data on this.

Owner Responsibilities: The owner will be responsible for all costs associated with the clinical workup and treatment of their dog's nasal tumor, including any complications experienced as a result of this procedure.  At this time, a general estimate of cost for the treatment procedure is around $2500; although, this may vary from dog-to-dog and depend on the presence of other underlying disease processes.  If you wish to have the response to the treatment assessed, this is usally done by a repeat CT scan 2-3 months after the procedure.  This is not included in the treatment estimate and would be your financial responsibility if you should choose to pursue it.  

Contact: If you would like to pursue treatment of your pet with the transare cryoablation procedure, please contact the scheduling coordinators in Soft Tissue Service at 530-752-1393 for a nasal cryoablation information sheet with additional information, or to schedule an appointment with Dr. Steffey. Please let them know that this appointment is for nasal cryoablation so that an appropriate reservation for the CT time needed to perform the procedure may be made.  

If you have already had CT imaging performed and would like Dr. Steffey's opinion on whether your dog would be eligible for cryoablation treatment, please send the following:

  • A brief summary of the course of your pet's nasal disease, including time of diagnosis and treatment received to date from your veterinarian
  • Your pet's medical records (especially the cytology or biopsy report with the diagnosis of the specific type of cancer)
  • A copy of the CT Scan sent on DVD

This information may be sent to Dr. Michele Steffey, c/o Theresa Varland, Veterinary Medical Teaching Hospital, School of Veterinary Medicine, University of California, Davis, One Garrod Drive, Davis CA 95616

Nasal cancer: Evaluating Chemoembolization as a Treatment Option

Title: Transarterial Chemoembolization of Nasal Tumors

Purpose of Study: The objective of this study is to evaluate alternative treatment options for patients with nasal tumors. Radiation therapy is still considered the gold standard of treatment for this disease, however clients who do not wish to pursue radiation therapy, or whose dog has failed radiation therapy may be eligible for participation in this study.

Participation Requirements:

  • Inclusion Criteria:
    • Confirmed diagnosis via cytology or histopathology (biopsy). Only dogs with tumors INSIDE the nose are eligible. This may have been done by another veterinarian, but results need to be made available to Dr. Steffey
    • CT scan performed by the UCDAVIS Radiology Department within 3 weeks of enrollment. If you are coming to UCDavis for workup of your dog’s nasal mass, nasal discharge, or nasal bleeding, PLEASE contact Dr. Steffey or discuss your interest in this study with your attending clinician BEFORE your CT scan is scheduled. If the correct pre-treatment CT parameters are not used, your dog cannot participate in the study.
    • CBC, Chemistry Panel and Urinalysis all within two weeks of enrollment (referring blood work is acceptable as long as it was performed at a commercial lab)
    • Clients *must* be willing to return at 1 month, 4 months, and 8 months for study rechecks, including a CT scan under brief general anesthesia. There is no charge for these rechecks, but it is imperative that the patient return for re-evaluation.
  • Exclusion Criteria
    • Dogs that have disease that invades the cribriform plate or is otherwise too extensive to treat safely with chemoembolization are not eligible for this study
    • Dogs that have pre-existing kidney disease that would exclude the use of radiographic contrast agents are not eligible

Initial Evaluation for Participation: All dogs must be examined by a VMTH oncology, internal medicine, radiation oncology service or soft tissue surgery veterinarian, and require the baseline evaluations described above at the owners expense before a dog can be considered for enrollment in the trial.

Procedures:

  • Chemoembolization procedure is a minimally invasive procedure. Chemotherapy and an embolic agent to obstruct the tumor blood supply are delivered directly to the tumor blood supply via special catheters
  • Recheck CT scans at 1 month, 4 months, and 8 months under general anesthesia

Benefits: THIS IS A PARTIALLY FUNDED STUDY. The procedure costs of this experimental procedure are covered by the study (an approximately $1500-2000 value to the client), but the individualized costs of the patient's care at the time of the treatment (anesthesia, hospitalization, medications, other individualized diagnostic tests needed to ensure the patient is safe for the procedure, etc) are the responsibility of the client. There will be no charge for the study rechecks at 1 month, 4 months, and 8 months. You will be financially responsible for the charges associated with the clinical care of your dog beyond the stipends provided.

Owner Responsibilities: The owner will be responsible for scheduling recheck appointments at 1 month, 4 months, and 8 months post-treatment and keeping those appointments as required by protocol. Owners also have the responsibility to cover the cost of the initial examination, blood work, pre-treatment CT scan, and any additional diagnostic tests and medications prescribed. Lastly, the owner will need to cover the cost of treatment of any complications experienced as a result of this procedure.

Contact: Contact the scheduling coordinators in Soft Tissue Surgery at (530) 752-1393 for Dr. Steffey's study.

Nasal cancer: Comparing Imaging Techniques and Assessing Vascular Therapies

Title: Nasal Tumors: Comparison of CT and MRI Findings in the Characterization of Canine Sinonasal Neoplasia and Assessment of Outcome with Vascular-Based Therapies (Embolization/Chemoembolization)

Purpose of Study: The purpose of this study is to prospectively evaluate dogs diagnosed with nasal tumors, including documentation of signalment, histologic diagnosis, treatment, and the results of a CT scan as compared to an MRI scan. We will also assess response to vascular-based therapies, such as embolization and chemoembolization.

Participation Requirements: Dogs with diagnosed nasal tumors

Initial Evaluation for Participation: Contact Dr. Culp for details at wculp@ucdavis.edu or (530) 752-1393.

Procedures: If a CT scan is recommended to further characterize the dog’s suspected nasal tumor, an MRI scan will be performed immediately following the CT scan. The MRI scan will be performed under the same general anesthetic event as the CT scan. Additionally, options concerning vascular-based therapies (embolization and chemoembolization) will be discussed and offered.

Benefits: The MRI scan and the anesthesia associated with the MRI scan will be paid for by the study. The MRI scan will offer another imaging modality that your clinician can use to make therapeutic recommendations. 

Owner Responsibilities: The owner will be responsible for scheduling appointments (initial and 2-month follow-up) and keeping those appointments as required by protocol. Financial assistance for some treatments will also be discussed upon consent.

Contact: Contact Dr. Culp for details at wculp@ucdavis.edu or (530) 752-1393.

Nasal cancer: Using a Combination of Therapies for Treatment

Title: Nasal tumors: Intra-arterial Chemotherapy and Radiotherapy to Treat Nasal Carcinoma

Purpose of Study: The purpose of this study is to prospectively evaluate the response of nasal cancer to a combination of therapies (chemotherapy and radiation therapy) in dogs.

Participation Requirements: Dogs diagnosed with nasal tumors

Initial Evaluation for Participation: Contact Dr. Culp for details at wculp@ucdavis.edu or (530) 752-1393.

Procedures: Dogs that are scheduled to receive radiation therapy for the treatment of nasal cancer can be enrolled in the study. Dogs will be placed into a group receiving radiation therapy alone or with chemotherapy.  Response to these treatments will be assessed with CT scans (done before and after treatment).

Benefits: The CT scans, chemotherapy administration, and part of the radiation therapy will be paid for by the study.

Owner Responsibilities: The owner will be responsible for providing follow-up information to the treating clinicians and returning the dog 4 weeks after initiation of radiation therapy for a second CT evaluation (the first is performed prior to treatment).

Contact: Contact Dr. Culp for details at wculp@ucdavis.edu or (530) 752-1393.

Primary Pulmonary Tumor: Tumor Collection

Title: Pfizer-CCOGC Biospecimen Repository study

Purpose of Study: UC Davis in collaboration with Pfizer-CCOGC Biospecimen Repository is collecting samples to populate a tissue bank for future research studies. The goal of the CCOGC and UC Davis will be to populate the Pfizer-CCOGC Biospecimen Repository with diseased tissues and specific normal tissues from dogs with cancer over the next three years. The study is guided by the National Cancer Institute (NCI).

Participation Requirements:

  • Owner consent to allow collection of the clinical specimens and to comply with follow-up and treatment requirements
  • General clinical evaluation, including the medical history, physical exam, complete blood count, biochemical profile, and urinalysis
  • Clinical presentation consistent with pulmonary tumor (Histological diagnosis confirmed post collection).
  • Surgical excision or collection immediately following euthanasia

Initial Evaluation for Participation: Dogs with a confirmed diagnosis of oral malignant melanoma

Procedures: After receiving consent from owners, a sample of the tumor is banked following the CCOGC criteria.

Benefits: There is no cost to the owner for participation in this study. The samples collected will be stored for future use of investigators with the ultimate goal of developing a treatment and prevention for the variety of cancers.

Owner Responsibilities: The owner only needs to consent to the sample being collected at the time of the visit.

Contact: Please talk to your oncologist at the time of your visit.

Primary Pulmonary Cancer: Using Lymphography to Identify Lymph Nodes

Title: Assessment of intraoperative lymphography as an aid to identification of regional lymph nodes in patients with primary lung tumors

Purpose of Study: Whether or not there is metastatic tumor in the regional lymph nodes is very important prognostic information for dogs with lung tumors, as dogs that do not have metastatic disease in their lymph nodes in general have a much longer lifespan. The aim of this study is to provide information that will allow us to better identify these lymph nodes at surgery to improve the safety of surgical dissection and minimize surgical time during removal of these lymph nodes.

Participation Requirements:

  • A diagnosis of a solitary lung tumor
  • Your decision to have a CT performed for staging and surgical planning of your dog’s disease
  • Your decision to pursue surgical removal of your dog’s lung tumor

Initial Evaluation for Participation: None.

Procedures: During surgery, surgical dyes will be injected into the lung around your dog’s tumor and uptake by the regional lymph nodes will be assessed.

Benefits: If your dog’s lung tumor is deemed safe to inject and you elect to take your dog to surgery, the study will retroactively pay for the CT scan ($800 value to the client). This benefits you as a thoracic CT is an important part of staging and surgical planning for any patient with a primary lung tumor. However if your dog’s tumor is not in a location that is safe to inject based on the initial plain CT scan, OR if you decide not to take your dog to surgery based on the initial plain CT scan (for example, because metastatic disease is found) then your dog cannot participate in the study and you must be prepared to pay for the CT.

Owner Responsibilities: There is no additional cost to you for your dog’s participation in the study. In return for your dog’s participation, the study will retroactively pay for the cost of your dog’s CT scan (and $800 value to you).  The study will not pay for the CT scan if you do not elect to have your dog’s lung tumor surgically removed.

Contact: Call (530) 752-1393 to talk to the Specialty Coordinators or Technicians in Soft Tissue Surgery  about Dr. Steffey's study.

Prostate cancer: Evaluating Embolization as a Treatment Option

Title: Evaluation of the Use of Embolization in the Treatment of Prostatic Neoplasia

Purpose of Study: The purpose of this project is to describe the procedure of prostatic artery embolization in a group of dogs with naturally-occurring prostate cancer. A secondary objective is to evaluate the effect that prostatic artery embolization has on clinical signs and the size of the tumor.

Participation Requirements: Dogs with prostate cancer

Initial Evaluation for Participation: Contact Dr. Culp for details at wculp@ucdavis.edu or (530) 752-1393.

Procedures: Dogs will undergo prostatic artery embolization. Pre-procedural ultrasound imaging and computed tomographic findings will be compared to post-procedural ultrasound imaging and computed tomographic findings. Complications associated with the procedure will be recorded and owners will receive a questionnaire to assess the clinical signs of the dog both pre- and post-procedure.

Benefits: The benefits of enrolling in this study include financial support for both pre- and post-procedure diagnostics. Additionally, funding from this grant will be applied towards the procedure. We hope that the data acquired in this study will allow us to advance the treatment of cancer in both dogs and people.

Owner Responsibilities: The owner will be responsible for scheduling appointments (initial and 1 month follow-up) and keeping those appointments as required by protocol.

Contact: Contact Dr. Culp for details at wculp@ucdavis.edu or (530) 752-1393.

Prostate, Urethra and/or Bladder Tumors: Evaluating Urodynamic Testing

Title: Prospective Evaluation of Urodynamic Testing in Dogs Undergoing Urethral Stent Placement to Relieve Malignant Urethral Obstruction

Purpose of Study: The purpose of this project is to determine the urethral and bladder pressures of dogs with cancer-induced urethral obstructions and in dogs with urethral stents.

Participation Requirements: Dogs with tumors causing obstruction of the urethra (bladder, urethra and prostate)

Initial Evaluation for Participation: Contact Dr. Culp for details at wculp@ucdavis.edu or (530) 752-1393.

Procedures: Urodynamic studies will be performed at the time of stent placement. Following the urodynamic studies, a urethral stent will be placed. At 3 weeks post-stent placement, canine continence scores will be obtained from clients regarding the dog’s voiding habits and urodynamic studies will be performed again.

Benefits: The goal of placing the stent is to improve the dog’s quality of life. All anesthetic episodes (2) will be paid for by the study. Additionally, all charges associated with the bladder and urethral pressure assessment will be paid for by the study. There are 2 major study benefits:

  1. We will be able to inform clients of the pressures in their dog’s bladder and urethra and discuss the possible implications of this; and,
  2. Financial compensation.

Owner Responsibilities: The owner will be responsible for scheduling appointments (initial and 3 weeks after stent placement) and keeping those appointments as required by protocol. Additionally, the owner will need to fill out forms related to their dog’s continence status.

Contact: Contact Dr. Culp for details at wculp@ucdavis.edu or (530) 752-1393.

Urethra/Bladder Tumors: Determining Tumor Size with Imaging

Title: Bladder/Urethra Tumors: Assessment and Comparison of Lower Urinary Tract Neoplasia Size and Location with Multiple Imaging Modalities

Purpose of Study: The purpose of this study is to prospectively evaluate dogs with bladder and urethral tumors and assess the best means for determining tumor size. The overarching goal is to improve our ability to treat these tumors with urethral stenting.

Participation Requirements: Dogs with bladder or urethral tumors

Initial Evaluation for Participation: Contact Dr. Culp for details at wculp@ucdavis.edu or (530) 752-1393.

Procedures: Dogs that are undergoing urethral stenting will undergo trans-rectal ultrasound (in addition to abdominal ultrasound) and MRI evaluation of the bladder/urethral tumor in order to determine tumor size and location.

Benefits: The MRI scan, the trans-rectal ultrasound and the anesthesia associated with these diagnostics will be paid for by the study. The MRI scan and trans-rectal ultrasound will offer additional imaging modalities that your clinician can use to make therapeutic recommendations.

Owner Responsibilities: The owner will be responsible for providing follow-up information to the treating clinicians.

Contact: Contact Dr. Culp for details at wculp@ucdavis.edu or (530) 752-1393.