CCC Co-Director Xinbin Chen
Oncology - Clinical Trials
Oncology - Clinical Trials
Thank you for allowing us the opportunity to play a part in your pet's health care. As a university teaching hospital, it is our goal to learn more about the debilitating cancers that our beloved pets experience. Through collaborations within and beyond UC Davis, we are conducting various cancer-related studies at the leading edge of cancer research. When your pet participates in one of our studies, you allow us the opportunity to increase our understanding of this debilitating disease that plagues loved ones, both humans and animals.
Canine patients with cancer
Canine patients with osteosarcoma
Canine patients with lymphoma
Feline patients with any type of cancer
Other studies
Cancer
Patient Disease:
Mast cell tumor
Study Name:
Palladia vs. vinblastine in canine mast cell tumors.
Purpose of the Study:
Mast cell tumor is a common skin tumor of dogs. Current treatment options available for mast cell tumor include various combinations of surgery, chemotherapy drugs such as vinblastine or lomustine, radiation therapy, and the new oral mast cell tumor drug Palladia® (toceranib).
Vinblastine is an intravenous chemotherapy agent that is commonly used in the treatment of mast cell tumors. 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 mast cell tumors, and Palladia has been shown to be more effective against tumors with this mutation. Through this clinical trial, we are seeking to investigate the difference in responses of mast cell tumors with and without a mutation in KIT to Palladia and vinblastine.
Patient Entry Criteria:
Dogs with confirmed mast cell tumor, with or without lymph node involvement, are eligible for this study. Dogs must undergo some diagnostic testing prior to starting the study to ensure that they are eligible, including bloodwork (complete blood count and chemistry profile), regional lymph node aspirate, thoracic radiographs, and abdominal ultrasound. They must have good function of liver and kidneys, have acceptable blood cell counts, and are free of severe underlying disease. Prior surgery for mast cell tumor is acceptable, but no previous chemotherapy is permitted.
Owner Responsibilities:
The owner is responsible for the cost of diagnosing and staging the mast cell tumor prior to entering the study (approximately $600.00-800.00). Owners are expected to make and keep all appointments according to the study protocol. In addition, they must be comfortable administering oral medications at home, and must be committed to completing the entire study protocol and follow-up examinations.
Financial Incentives:
Clients participating in this study will be given special financial considerations. 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, the recheck examinations, complete blood counts, and ancillary medications (Benadryl, omeprazole, prednisone).
Patient Disease
Canine patients with any tumor type scheduled for surgery at UCDAVIS
Study Name
Intratumoral concentrations of enrofloxacin and its metabolite ciprofloxacin in spontaneously arising canine tumors
Purpose of the Study
Preliminary data in our laboratory and others indicates that the fluoroquinolone class of antibiotics (enrofloxacin and ciprofloxacin) can inhibit tumor cell growth and may result in synergistic tumor cell killing when combined with traditional chemotherapeutic agents. While blood and normal tissue concentrations of enrofloxacin have been reported in the dog, the achievable intratumoral concentration of these drugs has not been reported in any species. We intend to measure intratumoral concentrations of enrofloxacin and its metabolite ciprofloxacin in a variety of canine tumors to determine if the drug actually reaches the tumor in high enough concentrations to be effective.
Eligibility Requirements
All dogs must be examined by a VMTH oncology or radiation oncology service veterinarian, and require the following baseline evaluations at the owners expense before a dog can be considered for enrollment in the trial:
- Confirmed diagnosis
- Physical examination with weight recorded
- CBC, Chemistry Panel and Urinalysis All within two weeks of enrollment (referring blood work is acceptable as long as it was ran at a commercial lab)
Baseline Evaluation for Eligibility
- Histologically or cytologically confirmed disease
- Patient must be a surgery candidate.
- Informed owner consent
Benefits:
There are no direct benefits to you or your pet for enrolling your pet in this study. However, we hope that the data acquired in this study will allow us to advance the treatment of cancer in both pets and people.
Patient Disease
Canine patients that present to UCDAVIS with Soft Tissue Sarcoma, Transitional Cell Carcinoma of the bladder or Thyroid Cancer
Study Name
VEGFR Ultrasound Study
Purpose of the Study
The purpose of this study is to assess a novel ultrasound technique for its ability to approximate a tumors angiogenic potential. This technique involves the intravenous injection of a contrast agent that is targeted to a specific feature (vascular endothelial growth factor receptor or VEGFR density) of highly angiogenic blood vessels in the tumor. Our goal is to use this ultrasound technique to measure VEGFR density before therapy is instituted and compare this to special VEGFR stains of biopsied tumor tissue to ensure that the ultrasound technique truly approximates angiogenesis. This may allow us to prognosticate regarding future behavior of the tumor. In addition, we believe that this measure may act as a predictor of response to chemotherapy.
Eligibility Requirements
All dogs must be examined by a VMTH oncology or radiation oncology service veterinarian, and require the following baseline evaluations at the owners expense before a dog can be considered for enrollment in the trial:
- Confirmed cytologic diagnosis of transitional cell carcinoma, soft tissue sarcoma (including histiocytic sarcoma) or thyroid carcinoma
- No previous treatment is eligible for enrollment
- Dogs with a confirmed Tumor must be within 6 cm of the skin surface to be eligible
- Owners must opt for surgical resection and/or biopsy
- Physical examination with weight recorded
- CBC, Chemistry Panel and Urinalysis All within two weeks of enrollment (referring blood work is acceptable as long as it was ran at a commercial lab)
- Informed owner consent
Exclusion Criteria: Dogs will be excluded if they have evidence of cardiac disease or a history of anaphylactic reactions to vaccines, contrast agents or other medications. Dogs with any of the following characteristics are NOT eligible for enrollment:
- Creatinine > 3.0
- Bilirubin > 1.0
- ALT > 400 IU/L
- HCT < 25%
- Platelets < 50,000/µl
- Dogs with urethral stents
- Favorable performance status at the discretion of the treating clinician
Thoracic radiographs must be obtained to rule out evidence of severe cardiac disease.
Patient Disease
Canine patients with any tumor type scheduled for surgery at UCDAVIS
Study Name
Intratumoral concentrations of enrofloxacin and its metabolite ciprofloxacin in spontaneously arising canine tumors (STUDY CURRENTLY ON HOLD)
Purpose of the Study
Preliminary data in our laboratory and others indicates that the fluoroquinolone class of antibiotics (enrofloxacin and ciprofloxacin) can inhibit tumor cell growth and may result in synergistic tumor cell killing when combined with traditional chemotherapeutic agents. While blood and normal tissue concentrations of enrofloxacin have been reported in the dog, the achievable intratumoral concentration of these drugs has not been reported in any species. We intend to measure intratumoral concentrations of enrofloxacin and its metabolite ciprofloxacin in a variety of canine tumors to determine if the drug actually reaches the tumor in high enough concentrations to be effective.
Eligibility Requirements
All dogs must be examined by a VMTH oncology or radiation oncology service veterinarian, and require the following baseline evaluations at the owners expense before a dog can be considered for enrollment in the trial:
- Confirmed diagnosis
- Physical examination with weight recorded
- CBC, Chemistry Panel and Urinalysis All within two weeks of enrollment (referring blood work is acceptable as long as it was ran at a commercial lab)
Baseline Evaluation for Eligibility
- Histologically or cytologically confirmed disease
- Patient must be a surgery candidate.
- Informed owner consent
Benefits:
There are no direct benefits to you or your pet for enrolling your pet in this study. However, we hope that the data acquired in this study will allow us to advance the treatment of cancer in both pets and people.
Patient Disease
Canine patients that present to UCDAVIS with Soft Tissue Sarcoma, Transitional Cell Carcinoma of the bladder or Thyroid Cancer
Study Name
VEGFR Ultrasound Study
Purpose of the Study
The purpose of this study is to assess a novel ultrasound technique for its ability to approximate a tumors angiogenic potential. This technique involves the intravenous injection of a contrast agent that is targeted to a specific feature (vascular endothelial growth factor receptor or VEGFR density) of highly angiogenic blood vessels in the tumor. Our goal is to use this ultrasound technique to measure VEGFR density before therapy is instituted and compare this to special VEGFR stains of biopsied tumor tissue to ensure that the ultrasound technique truly approximates angiogenesis. This may allow us to prognosticate regarding future behavior of the tumor. In addition, we believe that this measure may act as a predictor of response to chemotherapy.
Eligibility Requirements
All dogs must be examined by a VMTH oncology or radiation oncology service veterinarian, and require the following baseline evaluations at the owners expense before a dog can be considered for enrollment in the trial:
- Confirmed cytologic diagnosis of transitional cell carcinoma, soft tissue sarcoma (including histiocytic sarcoma) or thyroid carcinoma
- No previous treatment is eligible for enrollment
- Dogs with a confirmed Tumor must be within 6 cm of the skin surface to be eligible
- Owners must opt for surgical resection and/or biopsy
- Physical examination with weight recorded
- CBC, Chemistry Panel and Urinalysis All within two weeks of enrollment (referring blood work is acceptable as long as it was ran at a commercial lab)
- Informed owner consent
Exclusion Criteria: Dogs will be excluded if they have evidence of cardiac disease or a history of anaphylactic reactions to vaccines, contrast agents or other medications. Dogs with any of the following characteristics are NOT eligible for enrollment:
- Creatinine > 3.0
- Bilirubin > 1.0
- ALT > 400 IU/L
- HCT < 25%
- Platelets < 50,000/µl
- Dogs with urethral stents
- Favorable performance status at the discretion of the treating clinician
Thoracic radiographs must be obtained to rule out evidence of severe cardiac disease.
Patient Disease
Canine patients with Bladder Cancer
Study Name
Quantitative Contrast Ultrasound Imaging of Canine Bladder Tumors
Purpose of the Study Bladder tumors are a relatively common type of cancer in dogs. They often are large enough or occur in a bad enough location that surgical removal is not possible. Thus, chemotherapy is the standard treatment with most dogs living for 6-12 months after diagnosis. Currently, there is no concensus regarding which chemotherapy results in the longest overall survival. Some dogs may have a better response to one type of chemotherapy while others respond better to a different type. The purpose of this study is to assess a novel ultrasound technique for its ability to predict whether a dog is responding to chemotherapy early in the course of treatment. This technique involves the intravenous injection of a contrast agent that allows for visualization of blood vessels in the tumor. Many chemotherapeutic agents will kill blood vessels as well as directly killing tumor cells as a way of 'starving' a tumor of oxygen and nutrients. We intend to use this ultrasound technique to measure blood vessels before chemotherapy and then at set intervals after the onset of chemotherapy in an attempt to determine if blood vessels in the tumor are dying. We anticipate that this will allow us to predict which dogs are responding to chemotherapy and ultimately to allow us to determine if a dog should continue with a particular chemotherapuetic or if they should be switched to another drug that might work better for that individual.
Eligibility Requirements
All dogs must be examined by a VMTH oncology or radiation oncology service veterinarian, and require the following baseline evaluations at the owners expense before a dog can be considered for enrollment in the trial:
- Confirmed diagnosis
- Physical examination with weight recorded
- CBC, Chemistry Panel and Urinalysis All within two weeks of enrollment (referring blood work is acceptable as long as it was ran at a commercial lab)
Baseline Evaluation for Eligibility
- Histologically or cytologically confirmed diagnosis of transitional cell carcinoma with no previous treatment
- Identifiable bladder mass
- No evidence of severe cardiac disease
- Informed owner consent
This study is partially funded; the cost of the ultrasounds is paid for. The owner is responsible for all other fees.
Patient Disease
Canine Patients with Osteosarcoma
Study Name
Pathologic fracture risk of tumor-bearing canine antebrachii
Purpose of the Study
The objective of this study is to measure the reduction in bone strength due to the presence of osteosarcoma in the radius/ulna of the dog by measuring the force at which these bones break in a mechanical testing device. These measurements obtained by testing tumor-bearing bones from clinical patients will be compared to measurements performed in normal bones. Tumor–bearing bones will be obtained from clinical canine patients that are undergoing amputation of the affected limb as standard of care treatment for their bone tumor, and testing of these limbs will not affect care received by these patients. Computed tomography (CT) images of these bones will also be obtained, and this study will seek to correlate calculated CT indices of bone strength with the biomechanically measured bone strength. It is hoped that correlations found will allow prediction of patients at most risk for pathologic fracture, improve patient selection for current treatment options such as palliative radiation therapy, and aid in the development of new minimally invasive limb-salvage procedures.
Eligibility Requirements
All dogs must be examined by a VMTH oncology, radiation oncology service or soft tissue surgery veterinarian, and require the following baseline evaluations at the owners expense before a dog can be considered for enrollment in the trial:
- Confirmed diagnosis
- Physical examination with weight recorded
- CBC, Chemistry Panel and Urinalysis All within two weeks of enrollment (referring blood work is acceptable as long as it was ran at a commercial lab)
Baseline Evaluation for Eligibility
- Histologically or cytologically confirmed disease
- Disease in the radius/ulna
- Surgery performed by UCDAVIS Soft Tissue Surgery Department
- Informed owner consent
Procedures
1) CT of your dog’s forelimbs under general anesthesia BEFORE surgical removal
2) Biomechanical testing of your dog’s amputated limb AFTER surgical removal
Your dog is presenting to the UC Davis VMTH for treatment of a primary bone tumor of the distal radius (end of the front leg) by forelimb amputation. Amputation is currently the standard of care treatment to remove the tumor with wide margins with the fewest potential complications. If you agree to allow your animal to participate, he/she will be treated as usual in terms of his/her clinical workup and staging. At the time your dog is anesthetized for his/her amputation procedure, you agree to allow us to perform a computed tomography (CT) scan with and without intravenous contrast of your dog’s front legs (both legs will be done in the same scan) to image the tumor. While CT imaging is commonly performed as part of surgical planning for other diseases, this is unlikely to specifically benefit your dog as amputation is designed to remove the tumor with wide margins and CT results are not likely to alter the surgical plan. CT imaging is anticipated to require 30 minutes of anesthesia additional to that required for normal clinical management for the surgical procedure. Amputation of the limb will be performed as usual, and there will be no further deviations in the clinical care of your dog as recommended by the Surgery Service. After the limb with the tumor is removed, it will be taken for biomechanical testing. Once biomechanical testing is completed, the tumor or a portion of it will be submitted for histopathologic analysis as per standard of care.
Benefits
CT of Forelimbs and $325 applied toward total cost of your dog’s anesthesia, which covers the first two hours of anesthesia. This will cover the anticipated time needed to perform the CT imaging (30 minutes) as well as provide a financial benefit to allowing your pet to participate in this study as the remainder of this time will be applied toward your dog’s surgical procedure. You will be financially responsible for the charges associated with the clinical care of your dog beyond the stipend provided.
Patient Disease
Dogs with Lymphoma/SH-7139
Study Name
Preclinical evaluation of a novel synthetic antibody for treatment of spontaneously occurring B-cell lymphoma in dogs.
Purpose of the Study
It is possible that treatment with SH 7139 will be an effective therapy for your dog’s lymphoma, and may result in remission. It is hoped that with the information obtained from this trial, SH 7139 can proceed to clinical trials in people with non-Hodgkin’s lymphoma.
Eligibility Requirements/Patient Entry Criteria:
The study will enroll adult dogs of any breed with peripheral lymphadenopathy, with confirmed B-cell lymphoma, with a life expectancy of at least 6 weeks. This study intends to recruit both newly diagnosed cases without previous treatment, and relapsed patients that may have failed other treatment options.
All dogs must be examined by a VMTH oncology or radiation oncology service veterinarian, and require the following baseline evaluations at the owners expense before a dog can be considered for enrollment in the trial:
- Confirmed diagnosis
- Physical examination with weight recorded
- CBC, Chemistry Panel and Urinalysis All within two weeks of enrollment (referring blood work is acceptable as long as it was ran at a commercial lab)
Baseline Evaluation for Eligibility
- Histologically or cytologically confirmed disease
- At least one measurable affected organ
- Informed owner consent
Financial Incentives
Dog owners participating in this study will be given special financial considerations. This is a fully funded trial, once the patient is determined eligible by the oncologist. The study will pay for the cost of the weekly exam fees, bloodwork, anti-body drug.
Owner’s Responsibilities
The owner will be responsible for scheduling appointments with the study coordinator and keeping those appointments as required by protocol. Owners also have the responsibility to cover the cost of the initial examination and blood work and any additional medications prescribed.
Patient Disease
Dogs with Lymphoma
Study Name
Novel Product Targeting T-Cell Lymphoma
Novel Product Targeting B-Cell Lymphoma in combination with Doxorubicin
Purpose of the Study
Lymphoma is one of the most common blood cancers affecting dogs of different type of breeds and ages. Lymphoma is a devastating disease that, when left untreated, will lead to death in weeks. There is no cure known to this disease. Current treatments involve the use of extensive chemotherapy and / or radiotherapy, resulting generally in an initial response followed by relapse, and eventually resistance. Further, these treatments may be associated with severe side effects affecting patient’s quality of life. Therefore, a more effective and safe treatment for canine lymphoma is urgently needed.
New treatments based on the use of tumor targeting Product (non-chemotherapeutic agents) have been developed and used for the treatment of lymphoma in humans achieving an improved treatment efficacy with survival extension and an improved quality of life while significantly reducing toxicity. These treatments have proven to be groundbreaking for humans.
This Product is designed specifically for dogs. This Product was shown to be safe in normal dogs and effective at depleting lymphoma cells in laboratory studies.
This study proposes the use of this Product to obtain additional data about its safety and its Pharmacokinetic and Pharmacodynamic properties in dogs with lymphoma.
Patient Entry Criteria
The study will enroll adult dogs of any breed with peripheral lymphadenopathy, with confirmed B-cell lymphoma or T-Cell lymphoma, with a life expectancy of at least 6 weeks.
Financial Incentives
Dog owners participating in this study will be given special financial considerations. The study will pay for the cost of the Product, which is not available anywhere outside the study, and will also cover for the cost of examination and blood work required by the study protocol after enrollment.
Owner’s Responsibilities
The owner will be responsible for scheduling appointments with the study coordinator and keeping those appointments as required by protocol. Owners also have the responsibility to cover the cost of the initial examination and blood work and any additional medications prescribed.
Patient Disease (Temporarily closed to other histologies, open for Oral Melanoma and Primary Lung Tumors)
Canine Patients with Osteosarcoma, Lymphoma, or Oral Malignant Melanoma, Mast Cell Tumors, Soft Tissue Sarcomas/ Histiocytic Sarcoma/Malignant Histocytosis, Primary Pulmonary Cancer, Hemangiosarcomas Study Name: Canine Comparative Oncology and Genomics Consortium (CCOGC) A Tissue Procurement Program
Purpose of the 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). After receiving consent from owners, a sample of the tumor is banked following the CCOGC criteria and will be stored for future use of investigators with the ultimate goal of developing a treatment and prevention for the variety of cancers.
Patient Entry Criteria
Canine Lymphoma
- Owner consent to allow collection of the clinical specimens and to comply with follow-up and treatment requirements
- General clinical evaluation: Medical history, physical exam, complete blood count, biochemical profile, and urinalysis
- No prior chemotherapy
- No steroid therapy within two weeks of sampling.
Optional
- Histological diagnosis
- Complete staging evaluation Thoracic and abdominal radiographs (or ultrasound), BM aspiration cytology (all sites and stages acceptable)
- Histology of primary site
Canine Osteosarcoma
- Owner consent to allow collection of the clinical specimens and to comply with follow-up and treatment requirements
- General clinical evaluation: Medical history, physical exam, complete blood count, biochemical profile, and urinalysis
- Histological diagnosis
- Complete staging evaluation, including thoracic radiographs
- Appendicular or axial but tumor must be excised to allow for tissue collection
- Histology of primary site
Canine Oral Malignant Melanoma
- Owner consent to allow collection of the clinical specimens and to comply with follow-up and treatment requirements
- General clinical evaluation: 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
Canine Soft Tissue Sarcoma/Histiocytic Sarcoma/ Malignant Histiocytosis
- Owner consent to allow collection of the clinical specimens and to comply with follow-up and treatment requirements
- General clinical evaluation: Medical history, physical exam, complete blood count, biochemical profile, and urinalysis
- Clinical presentation consistent with STS/HS/MH (Histiological diagnosis confirmed post collection).
- Complete staging evaluation, including thoracic radiographs
- Tumors in any location (Viscera, lung) are eligible
Canine Primary Pulmonary Tumors
- Owner consent to allow collection of the clinical specimens and to comply with follow-up and treatment requirements
- General clinical evaluation: Medical history, physical exam, complete blood count, biochemical profile, and urinalysis
- Clinical presentation consistent with Pulmonary Tumor (Histological diagnosis confirmed post collection).
- Surgical excisionor collection immediately following euthanasia.
Canine Mast Cell Tumor
- Owner consent to allow collection of the clinical specimens and to comply with follow-up and treatment requirements
- General clinical evaluation: Medical history, physical exam, complete blood count, biochemical profile, and urinalysis
- Cytological staging evaluation
- Histology of primary site
- Tumor should be greater than 2cm
Please talk to your oncologist at the time of your visit to find out how your dog can contribute to future research studies by submitting a small sample of your dogs cancer.
Patient Disease
Canine patients with Oral Malignant Melanoma
Study Name
P.A.G.
Purpose of the Study
The goal of this study is to evaluate the efficacy of using the enzyme Pegylated Arginine Deiminase (non-chemotherapy drug) as a subcutaneous injection.
Eligibility Requirements
Any prospective patient must be examined by the VMTH Oncology or Radiation Oncology service veterinarian, and require the following baseline evaluations at the owners expense before a dog can be considered for enrollment in the trial:
- Confirmed diagnosis
- Physical examination with weight recorded
- CBC, Chemistry Panel and Urinalysis All within two weeks of enrollment (referring blood work is acceptable as long as it was run at a commercial lab)
Baseline Evaluation for Eligibility
- Histologically or cytologically confirmed disease
- Measurable and biopsiable tumor
- Ability to stay overnight
- Dog has to be greater than 10kg
- Informed owner consent
Financial Incentive
This study is fully funded. Please contact the Oncology department for more information.
This is a Phase I study.
Other Studies
Patient Disease
Evaluation of a novel anticancer agent in tumor bearing dogs to define its pharmacokinetic profile and biological activity:COTCO18
Participation in this study
- Involves dogs with mammary carcinoma, melanoma, squamous cell carcinoma, or soft tissue sarcoma
- Study agent will be administered 4 times over a 21 day study period
- Advantage to the owner include supported staging of the disease and $1000 toward treatment recommended by their pet’s oncologist including surgical removal of the tumor.
- There is strong interest in recruiting patients with mammary carcinoma to this trial. Please refer these patients prior to surgical removal of their tumor.
Inclusion criteria
- histologically or cytologically confirmed malignant melanoma, squamous cell carcinoma or soft tissue sarcoma (amenable to serial biopsy; histology may be confirmed by pre-treatment biopsy)
- Cutaneous melanomas are eligible if confirmed as malignant melanoma histologically
- Cutaneous or oral squamous cell carcinomas are eligible
- tumor must be >3 in longest diameter
- histologically confirmed malignant mammary carcinoma (malignancy must be confirmed to establish eligibility)
- naïve, recurrent (previous surgery) or metastatic disease are eligible
- favorable performance status
- informed owner consent for trial
Exclusion criteria
- dogs < 10 kg in size
- dogs without measurable disease
- dogs with hemangiosarcoma or nasal tumors
- previous or concurrent chemotherapy, immunotherapy or radiation therapy
- Steroids and NSAIDs washout for 7 days prior to study initiation
- significant co-morbid illness, which includes but is not limited to renal or hepatic failure, history of congestive heart failure or clinical coagulopathy
- creatinine > ULN
- bilirubin > 2.0 or elevated bile acids
- HCT < 25%, platelets < 50,000
- any > grade 2 hematologic/biochemical abnormality
Study Basics
- This clinical trial is led by the National Cancer Institute (NCI) and conducted through the Comparative Oncology Trials Consortium.
- A clinical trial of a novel anticancer agent in tumor bearing dogs with either melanoma, soft tissue sarcoma, squamous cell carcinoma or mammary carcinoma intended to define biological changes in tumor and surrogate tissues following drug exposure that may elucidate mechanisms of action and potential biomarkers of its activity.
- The study period is 21 days
- 12 hour serial pharmacokinetic collections will be completed on study day 1 and 8
- Tumor biopsies will be collected pre-treatment then on study days 1, 8, and 15
- Carboplatin chemotherapy will be administered along with the study drug on Day 8
- A subset of mammary carcinoma dogs will be enrolled in a control cohort.
- Control cohort study period will be 15 days. These dogs will receive carboplatin chemotherapy alone without the study agent.
Benefit to owner:
Costs associated with this study will be provided during the dog’s participation. In the event there are any complications arising during the study period the dog’s management will be covered by study funds. This would include any unanticipated hospitalizations at the patient’s Veterinary Teaching Hospital.
Obligations of owner:
All dogs will be examined at UC Davis for baseline evaluations before eligibility can be assessed. Tests required for this assessment must be performed within two weeks of study initiation and include:
- tumor biopsy or cytology (for histologic determination)
- biopsy to confirm malignancy in mammary carcinoma
- CBC, serum biochemistry, urinalysis
The owner must return to UC Davis on study days 1, 4, 8, 15, and 22. Owners must allow a postmortem exam after death of the patient.
Patient Disease
Canine patients with any tumor type scheduled for surgery at UCDAVIS
Study Name
Intratumoral concentrations of enrofloxacin and its metabolite ciprofloxacin in spontaneously arising canine tumors (STUDY CURRENTLY ON HOLD)
Purpose of the Study
Preliminary data in our laboratory and others indicates that the fluoroquinolone class of antibiotics (enrofloxacin and ciprofloxacin) can inhibit tumor cell growth and may result in synergistic tumor cell killing when combined with traditional chemotherapeutic agents. While blood and normal tissue concentrations of enrofloxacin have been reported in the dog, the achievable intratumoral concentration of these drugs has not been reported in any species. We intend to measure intratumoral concentrations of enrofloxacin and its metabolite ciprofloxacin in a variety of canine tumors to determine if the drug actually reaches the tumor in high enough concentrations to be effective.
Eligibility Requirements
All dogs must be examined by a VMTH oncology or radiation oncology service veterinarian, and require the following baseline evaluations at the owners expense before a dog can be considered for enrollment in the trial:
- Confirmed diagnosis
- Physical examination with weight recorded
- CBC, Chemistry Panel and Urinalysis All within two weeks of enrollment (referring blood work is acceptable as long as it was ran at a commercial lab)
Baseline Evaluation for Eligibility
- Histologically or cytologically confirmed disease
- Patient must be a surgery candidate.
- Informed owner consent
Benefits:
There are no direct benefits to you or your pet for enrolling your pet in this study. However, we hope that the data acquired in this study will allow us to advance the treatment of cancer in both pets and people.
Patient Disease
Patients with Splenic Hemangiosarcoma
Study Name
Adriamycin vs. Epirubicin
Purpose of the Study
Comparing Adriamycin vs. Epirubicin over the course of six doses.
Criteria
Canine patients that have Splenic Hemangiosarcoma and has ruptured with a biopsy to confirm NO liver metastasis.
Financial Incentive
There is no financial incentive. We are currently running studies to compare the use of different drugs in different combinations to provide a more effective way of treating various diseases. Each envelope is randomly pulled comparing the different drug. There is no placebo and it is 'open-label' meaning you will know exactly what drug your pet is receiving.
Patient Disease
Canine pets with Anal Sac Andenocarcinoma/Gross disease
Study Name
Carboplatin/Piroxicam vs. Mitoxantrone/Piroxicam
Purpose of the Study
Comparing the two different agents, Carboplatin/Piroxicam vs. Mitoxantrone/Piroxicam
Financial Incentive
There is no financial incentive. We are currently running studies to compare the use of different drugs in different combinations to provide a more effective way of treating various diseases. Each envelope is randomly pulled comparing the different drug. There is no placebo and it is 'open-label' meaning you will know exactly what drug your pet is receiving.
Patient Disease
Canine pets with Anal Sac Andenocarcinoma post surgery
Study Name
Carboplatin/Piroxicam vs. Mitoxantrone/Piroxicam
Purpose of the Study
Comparing the two different agents, Carboplatin/Piroxicam vs. Mitoxantrone/Piroxicam
Financial Incentive
There is no financial incentive. We are currently running studies to compare the use of different drugs in different combinations to provide a more effective way of treating various diseases. Each envelope is randomly pulled comparing the different drug. There are no placebos and it is 'open-labeled' meaning you will know exactly what drug your pet is receiving.
Patient Disease
Canine pets with TCC (Transitional Cell Carcinoma) of the bladder
Study Name
Carboplatin/Piroxicam vs. Mitoxantrone/Piroxicam
Purpose of the Study
Comparing the two different agents, Carboplatin/Piroxicam vs. Mitoxantrone/Piroxicam
Financial Incentive
There is no financial incentive. We are currently running studies to compare the use of different drugs in different combinations to provide a more effective way of treating various diseases.Each envelope is randomly pulled comparing the different drug. There is no placebo and it is 'open-label' meaning you will know exactly what drug your pet is receiving.
