| PET CANCER CENTER Comprehensive guide to cancer diagnosis and treatment in cats and dogs |
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Last updated 2/19/2017
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| Clinical trials for mast cell tumors in dogs |
| Open clinical trials for dogs |
Find clinical trials for specific tumor types in dogs:
VARIOUS LOCATIONS
Study: Prospective, multicentre, randomised, double-blind, placebo-controlled, 2-parallel groups, phase
3 study to compare efficacy and safety of masitinib to placebo, with a randomisation 2:1 in treatment of
aggressive Grade 2 and Grade 3non-resectable mast cell tumors in dogs not previously treated by
radiotherapy, chemotherapy (other than corticosteroids) or tyrosine kinase inhibitors
Study Contact: CANDY MILLER at candy.miller@ab-science.com or 1-404-422-5170
Locations:
University of California-Davis--Davis, California
"Integrative Veterinary Oncology 2501 N 32nd Street Phoenix 85008"--Phoenix, Arizona
Vista Veterinary Specialists 7425 Greenhaven Drive, Sacramento, CA 95831--Sacramento, California
Silicon Valley Veterinary 7160 Santa Teresa Blvd, San Jose, CA 95139--San Jose, California
INLAND VALLEY EMEGENCY PET CLINIC 10 WEST 7th Street , Upland California 91786--Upland, California
Colorado State University--Fort Collins, Colorado
Atlantic Animal Clinic 1315 NE Sunview Ter, Jensen Beach, FL 34957--Jensen Beach, FL 34957, Florida
WestVet Emergency & Specialty Center 5019 N Sawyer Ave, Garden City, ID 83714--Garden City, Idaho
University of Minnesota--St Paul, Minnesota
Ark Animal Hospital 940 Sutton Place Liberty, MO 64068--Liberty, Missouri
VCA Vet Care Animal Hospital/Referral Cntr 9901 Montgomery Blvd NE Albuquerque NM 87111--Albuquerque, New Mexico
Katonah Bedford Vet Center 546 Bedford Road, Bedford Hills, NY 10507--Bedford Hills, New York
University of Tennessee--Knoxville, Tennessee
Summary:
AB Science is pleased to announce we are currently accepting patients for a study for the indication of Kinavet for dogs
with non-resectable cutaneous mast cell tumor. Dogs will be treated with Masitinib ( Study name for Kinavet) or placebo
(randomization 2 : 1 which means that 2 dogs out of three actually get the drug and 1 does not) for a 24-week period,
followed by an extension period in case of benefit. The dog owner will be provided with treatment for free and all required
medical examinations (biopsy histology, staging, blood monitoring...) are supported by AB Science. Dogs may leave the
study at any time, especially in case of progression, to receive another treatment.
Eligibility:
Dogs older than 1 year, weigh more than 6.9 kg (15 lbs)
Dogs have aggressive Grade 2 or 3, non-resectable, cutaneous mast cell tumor
Can be non-recurrent or recurrent
Tumor has to be of a certain size, and accessible for biopsy
Otherwise healthy
No previous chemotherapy or radiation therapy
Other restrictions apply
Exclusion:
Dog previously treated by toceranib phosphate or any chemotherapy or radiotherapy.
Dog with subcutaneous tumor.
Dog with bone marrow involvement.
Dog with major surgery within 2 weeks of treatment initiation.
Financial Incentive:
Study visits will be paid by the study. Owners may have additional costs to support the care of the dog related to the mast
cell tumor.
CALIFORNIA
Study: Sentinel lymph node mapping in dogs with mast cell tumors
Location: UC Davis - Davis, California
Study Contact: Dr. Stephanie Majeski (smajeski@ucdavis.edu) or Dr. Michele Steffey (masteffey@ucdavis.edu)
Call (530) 752-1393 to make an appointment
www.vetmed.ucdavis.edu/clinicaltrials/current_trials/by_species/dogs.cfm
Purpose:
Mast cell tumors are a very common skin tumor in dogs, and a common mechanism of spread in the body (metastasis) is to
nearby lymph nodes. If tumor spread to lymph nodes is identified (as part of staging), this is important information that
often influences treatment recommendations. Currently, standard protocols for looking for metastasis in lymph nodes most
commonly include aspiration cytology. Aspiration cytology is minimally invasive, but may miss a diagnosis of lymph node
metastasis in a concerning number of patients – early literature suggests metastatic disease may be missed by lymph
node aspiration in up to 40% of patients! The concern is that not only does aspiration cytology only sample a very small
amount of a given lymph node, but that it is difficult to ensure that we have correctly predicted the optimal lymph node to
sample for any given mast cell tumor. Lymph node mapping, a technique to visualize the lymphatic drainage of tumors by
which tumor cells might spread, is increasingly used to improve cancer staging and treatment protocols in the treatment of
cancer in humans. Efforts are made to identify the “sentinel lymph node,” or primary lymph node that is most likely to
demonstrate evidence of metastatic disease if it is present. This lymph node can then be surgically removed with the
primary tumor, in order to be evaluated microscopically for spread of cancer. However the common method of sentinel
lymph node mapping performed in people is not widely available to veterinarians. This trial is being performed to hopefully
identify an alternative method of sentinel lymph node mapping that can be more widely accessible to a greater number of
veterinary practitioners. By doing so, we hope that this will improve the accuracy of cancer diagnoses and treatment
recommendations we make for dogs with mast cell tumors and other cancers, improving their quality of life and lifespan.
Participation Requirements:
Dogs must have been diagnosed with a peripheral mast cell tumor, have been evaluated by or received a consult from a
clinician the Soft Tissue Surgery service to determine if LN mapping is viable for your individual dog, and you have elected
surgical excision of this tumor both for diagnostic and treatment purposes.
Initial Evaluation for Participation:
Evaluation by the U.C. Davis V.M.T.H. Oncology or Soft Tissue Surgery services. Specific preoperative diagnostic tests to
ensure that your pet is safe for surgical removal of the mast cell tumor will be recommended by the clinician that you
consult with on these services.
Procedures:
If you choose to enroll your dog, lymph node mapping procedures will be performed the day before and the day of surgery.
These will be discussed in more detail at the time of your appointment.
Benefits:
The study will cover costs associated with the sentinel lymph node mapping imaging. There is no charge to you for these
procedures.
Possible benefits of participating in this study for your dog include more sensitive identification of metastasis (spread of
cancer) if it is present. If early metastasis is more sensitively identified, we can then make more accurate treatment
recommendations for your pet. It is our hope that in addition to benefiting your dog, we will benefit future patients by
advancing the standard of care offered when treating this type of cancer, improving care provided to larger numbers of
veterinary cancer patients.
Owner Responsibilities:
If you allow your dog to participate in this study, you will be responsible for bringing your dog to the U.C. Davis V.M.T.H. for
1) preoperative evaluation of and 2) surgical removal of the mast cell tumor, and covering the standard costs associated
with medical workup for and surgical removal of the mast cell tumor.
If you are calling to schedule an appointment and already know that you are interested in having your dog participate in
this study, please inform the coordinators so that they can make sure to schedule appropriately for the mapping
procedures.
COLORADO / OHIO
Study: Correlation of circulating plasma levels of cytokeratin 18 (CK18) with diarrhea in dogs with mast
cell tumor treated with toceranib phosphate (Palladia)
Colorado Location: Colorado State University-Fort Collins, Colorado
Study Contact: Kara Hall at csuoncologytrials@colostate.edu or 1-970-297-4001
www.csuanimalcancercenter.org/correlation-of-circulating-plasma-levels-of-cytokeratin-18-ck18
Ohio Location: Ohio State University-Columbus, Ohio
Study Contact: Blue Buffalo Clinical Trials Office at CVM-ClinicalTrials@osu.edu or 1-614-247-8706
https://vet.osu.edu/vmc/cto/clinical-trials/trial-dogs-cancer-mast-cell-tumor-palladia
Summary:
Tyrosine Kinase Inhibitors (TKIs), including toceranib (Palladia), are a class of drugs that are being used with increased
frequency in both human and veterinary oncology. In both populations side effects occur in a large percentage of patients,
with many requiring dose reductions or drug holidays, potentially impacting treatment success. Toceranib is used
frequently in veterinary medicine and has been demonstrated to have a clinical benefit for dogs with a variety of tumor
types including mast cell tumors, anal gland anal sac adenocarcinoma, thyroid carcinomas, head and neck carcinomas,
nasal tumors, and metastatic osteosarcoma among others. The most commonly encountered side effects in dogs receiving
toceranib are reported to be gastrointestinal (GI) in nature and include diarrhea, vomiting, reduced appetite and weight
loss. The frequency and severity of these side effects is variable among individual dogs and currently there are no clinical
or molecular makers to identify those dogs that would benefit from the use of medications to prevent GI side effects. This is
critical as the development of GI side effects significantly impacts patient treatment. Importantly, dogs that develop GI side
effects are less likely to remain on toceranib therapy due to a negative impact on quality of life.
Purpose:
Purpose of the study: CK18 is expressed in epithelial cells of the gastrointestinal tract. During cell death fragments are
released into the bloodstream and can be utilized as a biomarker. Dogs treated with toceranib (Palladia) that have adverse
events, most commonly have gastrointestinal signs. This study evaluates the use of this CK18 as a biomarker to predict
gastrointestinal toxicity in dogs with mast cell tumors treated with Palladia.
Eligibility:
Dogs diagnosed with cutaneous or subcutaneous mast cell tumors. Must have had the tumor surgically removed and have
no evidence of recurrence or metastasis. Dogs must be in good health otherwise, with relatively normal lab work (complete
blood count, chemistry profile, urinalysis, urine protein test), and normal blood pressure. Dogs must not have
gastrointestinal symptoms. There must be a one week washout from chemotherapy or radiation therapy.
Exclusion:
Any prior radiation or chemotherapy for mast cell tumors; uncontrolled autoimmune hemolytic anemia or immune-mediated
thrombocytopenia; significant hypertension, protein-losing nephropathy, or liver disease; GI symptoms including vomiting
and diarrhea <5 days prior to study entry; any concurrent serious systemic disorder
Study Protocol:
Pre-enrollment: Physical exam, lab work (complete blood count, chemistry profile, urine testing), blood pressure
measurement, biopsy to confirm mast cell tumor and eligibility for the clinical trial. Day 0: start treatment , fill in daily log.
Weekly visits until day 28 for physical exams, lab work ,urine testing, blood pressure, and toxicity assessments. If the dog is
doing well, and the owner wishes to continue treatment, they will be given 3 additional months of Palladia at no cost.
Owner Responsibilities:
The cost of the initial diagnostics to confirm eligibility for enrollment, the exam fees, and diagnostics related to Palladia
treatment. The owner must also fill out a daily log to document Palladia administration and side effects. The owner is
expected to make and keep appointments according to the clinical trial protocol.
Financial Incentives:
The study will cover the cost of Palladia for the duration of the study (4 weeks) and then for an additional 3 months if this
treatment is continued.
OREGON
Study: Mast Cell Tumor Staging Study
Location: Oregon State University-Corvallis, Oregon
Study Contact: 541-737-4812
http://vetmed.oregonstate.edu/sites/vetmed.oregonstate.edu/files/mast_cell_clinical_trial.pdf
Purpose:
To evaluate if computed tomography (CT) is better than abdominal ultrasound for Mast Cell Tumor staging.
Eligibility:
Client-owned dogs affected by a cutaneous or subcutaneous Mast Cell tumor referred for staging.
Exclusion:
Dogs cannot have pre-operative prednisone or chemotherapy.
Partial exclusion criteria (may not qualify for all discounts but still may receive some financial incentives): previous surgical
excision of the tumor, immune-mediated diseases, coagulopathy, and/or endocrinopathy.
Financial Incentive:
Receive free Mast Cell Tumor staging, includes:
Sedation
Abdominal CT
Ultrasound of the liver and spleen with FNA cytology
Client will save ~$700 per dog
PENNSYLVANIA
Study #1: Evaluation of the efficacy and safety of feline interleukin-2 immunomodulator (ALVAC IL-2)
as a treatment for canine mast cell tumors
Location: Hope Veterinary Specialists-Malvern, Pennsylvania
Study Contact: 610-296-2099 or oncology@hopevs.com
http://hopevs.com/specialties/clinical-trials/mast-cell-tumor/
Summary:
Mast cell tumors (MCTs) account for 20-30% of all skin tumors in dogs. They are a cancer of mast cells, which are cells
important in the allergic response. MCTs occur in many breeds and in dogs with chronic allergic skin disease. About 50%
occur along the trunk and perineum, 40% along the extremities, and 10% along the head and neck. They may present as
a solitary lesion or can be multiple, with a variety of appearances (haired, ulcerated, pedunculated, etc). In most cases,
dogs have a history of the mass being present and changing in size over time, mostly due to the release of histamine that
causes local swelling. Staging for this cancer often involves blood work, lymph node aspirates, chest radiographs, and
abdominal ultrasound to ensure there is no evidence of internal cancer spread.
Most MCTs are associated with long-term survival after surgical excision, however, when surgery is not feasible due to
location, size, or owner preference, there is no true standard of care. Therefore, an effective treatment that can induce
regression on these tumors with minimal side effects is needed. In a recent pilot study in dogs treated with intra-tumoral
injections of human IL-2, there was a promising anti-MCT effect.
Purpose:
The purpose of this trial is to determine the efficacy and safety of the ALVAC IL-2 immunomodulator for the treatment of
cutaneous MCTs in dogs. All upon entry into the trial, patients will receive weekly intra-tumoral injections and then close
monitoring thereafter.
Eligibility:
- Clinical cases of measurable, cytologically-confirmed, cutaneous MCT (>1cm, <5cm).
- Written consent for entry to the trial from each dog’s owner, including consent for necropsy upon death from any reason
during the course of the study
Exclusion:
- Dogs with a significant co-morbid illness that, in the opinion of the investigator or sponsor, could compromise response to
the treatment, interfere with evaluation of its efficacy, or result in mortality within one year.
- Dogs having received previous immunotherapy
- Concurrent medications deemed incongruent with this study. Prednisone is allowed only if the patient was previously
receiving and experienced tumor progression while on prednisone.
- Dogs in the care of owners/designee living at a distance from the treatment center that in the opinion of the investigator
will make compliance with follow-up incompatible with reasonable travel arrangements.
Financial Incentive:
This study is partially funded and will cover most of the cost for staging (blood work, cytology, consultation) and
subsequent weekly study treatments (exam and blood work). Upon completion of the study, owners are also provided some
financial incentive to help defray the cost of either surgery or additional therapies.
Study #2: Evaluation of novel immunotherapy
Location: Hope Veterinary Specialists-Malvern, Pennsylvania
Study Contact: 610-296-2099 or oncology@hopevs.com
http://hopevs.com/specialties/clinical-trials/lymphoma-melanoma-mast-cell-tumors/
Summary:
This trial is designed to evaluate the safety and preliminary anti-cancer activity of a novel, monoclonal antibody in dogs
with measurable cancer. The antibody is administered IV by the study staff every 28 days for up to 5 treatments. There is
no placebo in this trial. An estimated 30 client-owned dogs with Lymphoma, Melanoma, or Mast Cell Tumors will be
enrolled. Visits will be required when the dogs begin the study, at Day 14, Day 28, and monthly thereafter for a total trial
period of 140 days.
Eligibility:
At least one measurable skin tumor +/- metastatic lymph node(s) > 2 cm
No intraabdominal metastasis
Prior therapy accepted with washout times to be discussed with the participating site
Financial Incentive:
The trial is fully funded for the full trial duration (140 days), including the antibody and trial-related procedures.
VIRGINIA
Study: The impact of neoadjuvant prednisone on grade and proliferation indices in canine cutaneous
mast cell tumors: A pilot study
Location: Virginia-Maryland Regional College of Veterinary Medicine-Blacksburg, Virginia
Study Contact: Mindy Quigley at vettrials@vt.edu or 1-540-231-1363
www.vetmed.vt.edu/clinical-trials/current-studies/mastcell.asp
Purpose:
To determine if administering prednisone prior to surgery affects the factors used to define the grade of mast cell tumors,
and thus potentially affects prognosis and treatment recommendations.
Background
Mast cell tumors are the most common malignant skin tumor in dogs. The prognosis is highly-dependent upon the tumor
grade, which can only be determined by histopathology (biopsy). For low-grade tumors, complete surgical removal is
curative. However, nearly 100% of dogs with high-grade tumors will succumb to their disease within 6 months to a year of
diagnosis. Treatment with prednisone is an effective treatment as sole therapy. It is also used prior to surgery to shrink the
tumor or as part of a chemotherapy protocol used in dogs with high-grade tumors. However, it is unknown how the use of
prednisone prior to surgery affects the factors used to define the tumor grade, which has potential to impact the prognosis
and recommended further treatment options.
Eligibility
Cytological diagnosis of cutaneous mast cell tumor
Body weight > 5kgTumor size of between 1 and 10 cm in diameter
Exclusion Criteria
Previous therapy to current tumor including chemotherapy, corticosteroids, tyrosine kinase inhibitors, or radiation.
(Recurrent tumor is acceptable, H1 and H2 blocking agents are acceptable).
Evidence of concurrent significant biochemical or hematological abnormalities
Study Design
All dogs will undergo a complete physical exam, lab work, and fine needle aspirate cytology of the tumor. If a definitive
diagnosis of mast cell tumor is obtained and other criteria are met, eligible dogs will be offered the opportunity to enroll in
the study. Within 7 days of enrollment, we will obtain a small incisional biopsy of the tumor and perform histopathological
tumor evaluation and determination of proliferation indices levels. You will then administer at-home treatment with daily
prednisone for 10-14 days. Following prednisone treatment, your pet will undergo surgical removal of the mast cell tumor.
The tumor will be submitted for diagnosis, tumor grading, and measurement. Once your pet is discharged from surgery,
your participation in the study is completed. After biopsy results are finalized, you will receive a phone call informing you of
these results. You will also receive recommendations for further tests or treatments by our Board-certified Veterinary
Oncologists. There is no obligation to pursue any further testing or treatment.
Compensation
Once the dog is deemed eligible and informed consent is obtained, the study will cover the expenses for the pre-treatment
biopsy, the prednisone treatment, and $1,000 towards the cost of surgery. This compensation will only partially cover the
cost surgical removal. Typical cost of a skin mass removal in the Veterinary Teaching Hospital is $1,800-2,200. You are
responsible for any other clinical fees associated with the screening procedures, surgery, any identified concurrent
medical issues, or complications associated with surgery.
Study: Prospective, multicentre, randomised, double-blind, placebo-controlled, 2-parallel groups, phase
3 study to compare efficacy and safety of masitinib to placebo, with a randomisation 2:1 in treatment of
aggressive Grade 2 and Grade 3non-resectable mast cell tumors in dogs not previously treated by
radiotherapy, chemotherapy (other than corticosteroids) or tyrosine kinase inhibitors
Study Contact: CANDY MILLER at candy.miller@ab-science.com or 1-404-422-5170
Locations:
University of California-Davis--Davis, California
"Integrative Veterinary Oncology 2501 N 32nd Street Phoenix 85008"--Phoenix, Arizona
Vista Veterinary Specialists 7425 Greenhaven Drive, Sacramento, CA 95831--Sacramento, California
Silicon Valley Veterinary 7160 Santa Teresa Blvd, San Jose, CA 95139--San Jose, California
INLAND VALLEY EMEGENCY PET CLINIC 10 WEST 7th Street , Upland California 91786--Upland, California
Colorado State University--Fort Collins, Colorado
Atlantic Animal Clinic 1315 NE Sunview Ter, Jensen Beach, FL 34957--Jensen Beach, FL 34957, Florida
WestVet Emergency & Specialty Center 5019 N Sawyer Ave, Garden City, ID 83714--Garden City, Idaho
University of Minnesota--St Paul, Minnesota
Ark Animal Hospital 940 Sutton Place Liberty, MO 64068--Liberty, Missouri
VCA Vet Care Animal Hospital/Referral Cntr 9901 Montgomery Blvd NE Albuquerque NM 87111--Albuquerque, New Mexico
Katonah Bedford Vet Center 546 Bedford Road, Bedford Hills, NY 10507--Bedford Hills, New York
University of Tennessee--Knoxville, Tennessee
Summary:
AB Science is pleased to announce we are currently accepting patients for a study for the indication of Kinavet for dogs
with non-resectable cutaneous mast cell tumor. Dogs will be treated with Masitinib ( Study name for Kinavet) or placebo
(randomization 2 : 1 which means that 2 dogs out of three actually get the drug and 1 does not) for a 24-week period,
followed by an extension period in case of benefit. The dog owner will be provided with treatment for free and all required
medical examinations (biopsy histology, staging, blood monitoring...) are supported by AB Science. Dogs may leave the
study at any time, especially in case of progression, to receive another treatment.
Eligibility:
Dogs older than 1 year, weigh more than 6.9 kg (15 lbs)
Dogs have aggressive Grade 2 or 3, non-resectable, cutaneous mast cell tumor
Can be non-recurrent or recurrent
Tumor has to be of a certain size, and accessible for biopsy
Otherwise healthy
No previous chemotherapy or radiation therapy
Other restrictions apply
Exclusion:
Dog previously treated by toceranib phosphate or any chemotherapy or radiotherapy.
Dog with subcutaneous tumor.
Dog with bone marrow involvement.
Dog with major surgery within 2 weeks of treatment initiation.
Financial Incentive:
Study visits will be paid by the study. Owners may have additional costs to support the care of the dog related to the mast
cell tumor.
CALIFORNIA
Study: Sentinel lymph node mapping in dogs with mast cell tumors
Location: UC Davis - Davis, California
Study Contact: Dr. Stephanie Majeski (smajeski@ucdavis.edu) or Dr. Michele Steffey (masteffey@ucdavis.edu)
Call (530) 752-1393 to make an appointment
www.vetmed.ucdavis.edu/clinicaltrials/current_trials/by_species/dogs.cfm
Purpose:
Mast cell tumors are a very common skin tumor in dogs, and a common mechanism of spread in the body (metastasis) is to
nearby lymph nodes. If tumor spread to lymph nodes is identified (as part of staging), this is important information that
often influences treatment recommendations. Currently, standard protocols for looking for metastasis in lymph nodes most
commonly include aspiration cytology. Aspiration cytology is minimally invasive, but may miss a diagnosis of lymph node
metastasis in a concerning number of patients – early literature suggests metastatic disease may be missed by lymph
node aspiration in up to 40% of patients! The concern is that not only does aspiration cytology only sample a very small
amount of a given lymph node, but that it is difficult to ensure that we have correctly predicted the optimal lymph node to
sample for any given mast cell tumor. Lymph node mapping, a technique to visualize the lymphatic drainage of tumors by
which tumor cells might spread, is increasingly used to improve cancer staging and treatment protocols in the treatment of
cancer in humans. Efforts are made to identify the “sentinel lymph node,” or primary lymph node that is most likely to
demonstrate evidence of metastatic disease if it is present. This lymph node can then be surgically removed with the
primary tumor, in order to be evaluated microscopically for spread of cancer. However the common method of sentinel
lymph node mapping performed in people is not widely available to veterinarians. This trial is being performed to hopefully
identify an alternative method of sentinel lymph node mapping that can be more widely accessible to a greater number of
veterinary practitioners. By doing so, we hope that this will improve the accuracy of cancer diagnoses and treatment
recommendations we make for dogs with mast cell tumors and other cancers, improving their quality of life and lifespan.
Participation Requirements:
Dogs must have been diagnosed with a peripheral mast cell tumor, have been evaluated by or received a consult from a
clinician the Soft Tissue Surgery service to determine if LN mapping is viable for your individual dog, and you have elected
surgical excision of this tumor both for diagnostic and treatment purposes.
Initial Evaluation for Participation:
Evaluation by the U.C. Davis V.M.T.H. Oncology or Soft Tissue Surgery services. Specific preoperative diagnostic tests to
ensure that your pet is safe for surgical removal of the mast cell tumor will be recommended by the clinician that you
consult with on these services.
Procedures:
If you choose to enroll your dog, lymph node mapping procedures will be performed the day before and the day of surgery.
These will be discussed in more detail at the time of your appointment.
Benefits:
The study will cover costs associated with the sentinel lymph node mapping imaging. There is no charge to you for these
procedures.
Possible benefits of participating in this study for your dog include more sensitive identification of metastasis (spread of
cancer) if it is present. If early metastasis is more sensitively identified, we can then make more accurate treatment
recommendations for your pet. It is our hope that in addition to benefiting your dog, we will benefit future patients by
advancing the standard of care offered when treating this type of cancer, improving care provided to larger numbers of
veterinary cancer patients.
Owner Responsibilities:
If you allow your dog to participate in this study, you will be responsible for bringing your dog to the U.C. Davis V.M.T.H. for
1) preoperative evaluation of and 2) surgical removal of the mast cell tumor, and covering the standard costs associated
with medical workup for and surgical removal of the mast cell tumor.
If you are calling to schedule an appointment and already know that you are interested in having your dog participate in
this study, please inform the coordinators so that they can make sure to schedule appropriately for the mapping
procedures.
COLORADO / OHIO
Study: Correlation of circulating plasma levels of cytokeratin 18 (CK18) with diarrhea in dogs with mast
cell tumor treated with toceranib phosphate (Palladia)
Colorado Location: Colorado State University-Fort Collins, Colorado
Study Contact: Kara Hall at csuoncologytrials@colostate.edu or 1-970-297-4001
www.csuanimalcancercenter.org/correlation-of-circulating-plasma-levels-of-cytokeratin-18-ck18
Ohio Location: Ohio State University-Columbus, Ohio
Study Contact: Blue Buffalo Clinical Trials Office at CVM-ClinicalTrials@osu.edu or 1-614-247-8706
https://vet.osu.edu/vmc/cto/clinical-trials/trial-dogs-cancer-mast-cell-tumor-palladia
Summary:
Tyrosine Kinase Inhibitors (TKIs), including toceranib (Palladia), are a class of drugs that are being used with increased
frequency in both human and veterinary oncology. In both populations side effects occur in a large percentage of patients,
with many requiring dose reductions or drug holidays, potentially impacting treatment success. Toceranib is used
frequently in veterinary medicine and has been demonstrated to have a clinical benefit for dogs with a variety of tumor
types including mast cell tumors, anal gland anal sac adenocarcinoma, thyroid carcinomas, head and neck carcinomas,
nasal tumors, and metastatic osteosarcoma among others. The most commonly encountered side effects in dogs receiving
toceranib are reported to be gastrointestinal (GI) in nature and include diarrhea, vomiting, reduced appetite and weight
loss. The frequency and severity of these side effects is variable among individual dogs and currently there are no clinical
or molecular makers to identify those dogs that would benefit from the use of medications to prevent GI side effects. This is
critical as the development of GI side effects significantly impacts patient treatment. Importantly, dogs that develop GI side
effects are less likely to remain on toceranib therapy due to a negative impact on quality of life.
Purpose:
Purpose of the study: CK18 is expressed in epithelial cells of the gastrointestinal tract. During cell death fragments are
released into the bloodstream and can be utilized as a biomarker. Dogs treated with toceranib (Palladia) that have adverse
events, most commonly have gastrointestinal signs. This study evaluates the use of this CK18 as a biomarker to predict
gastrointestinal toxicity in dogs with mast cell tumors treated with Palladia.
Eligibility:
Dogs diagnosed with cutaneous or subcutaneous mast cell tumors. Must have had the tumor surgically removed and have
no evidence of recurrence or metastasis. Dogs must be in good health otherwise, with relatively normal lab work (complete
blood count, chemistry profile, urinalysis, urine protein test), and normal blood pressure. Dogs must not have
gastrointestinal symptoms. There must be a one week washout from chemotherapy or radiation therapy.
Exclusion:
Any prior radiation or chemotherapy for mast cell tumors; uncontrolled autoimmune hemolytic anemia or immune-mediated
thrombocytopenia; significant hypertension, protein-losing nephropathy, or liver disease; GI symptoms including vomiting
and diarrhea <5 days prior to study entry; any concurrent serious systemic disorder
Study Protocol:
Pre-enrollment: Physical exam, lab work (complete blood count, chemistry profile, urine testing), blood pressure
measurement, biopsy to confirm mast cell tumor and eligibility for the clinical trial. Day 0: start treatment , fill in daily log.
Weekly visits until day 28 for physical exams, lab work ,urine testing, blood pressure, and toxicity assessments. If the dog is
doing well, and the owner wishes to continue treatment, they will be given 3 additional months of Palladia at no cost.
Owner Responsibilities:
The cost of the initial diagnostics to confirm eligibility for enrollment, the exam fees, and diagnostics related to Palladia
treatment. The owner must also fill out a daily log to document Palladia administration and side effects. The owner is
expected to make and keep appointments according to the clinical trial protocol.
Financial Incentives:
The study will cover the cost of Palladia for the duration of the study (4 weeks) and then for an additional 3 months if this
treatment is continued.
OREGON
Study: Mast Cell Tumor Staging Study
Location: Oregon State University-Corvallis, Oregon
Study Contact: 541-737-4812
http://vetmed.oregonstate.edu/sites/vetmed.oregonstate.edu/files/mast_cell_clinical_trial.pdf
Purpose:
To evaluate if computed tomography (CT) is better than abdominal ultrasound for Mast Cell Tumor staging.
Eligibility:
Client-owned dogs affected by a cutaneous or subcutaneous Mast Cell tumor referred for staging.
Exclusion:
Dogs cannot have pre-operative prednisone or chemotherapy.
Partial exclusion criteria (may not qualify for all discounts but still may receive some financial incentives): previous surgical
excision of the tumor, immune-mediated diseases, coagulopathy, and/or endocrinopathy.
Financial Incentive:
Receive free Mast Cell Tumor staging, includes:
Sedation
Abdominal CT
Ultrasound of the liver and spleen with FNA cytology
Client will save ~$700 per dog
PENNSYLVANIA
Study #1: Evaluation of the efficacy and safety of feline interleukin-2 immunomodulator (ALVAC IL-2)
as a treatment for canine mast cell tumors
Location: Hope Veterinary Specialists-Malvern, Pennsylvania
Study Contact: 610-296-2099 or oncology@hopevs.com
http://hopevs.com/specialties/clinical-trials/mast-cell-tumor/
Summary:
Mast cell tumors (MCTs) account for 20-30% of all skin tumors in dogs. They are a cancer of mast cells, which are cells
important in the allergic response. MCTs occur in many breeds and in dogs with chronic allergic skin disease. About 50%
occur along the trunk and perineum, 40% along the extremities, and 10% along the head and neck. They may present as
a solitary lesion or can be multiple, with a variety of appearances (haired, ulcerated, pedunculated, etc). In most cases,
dogs have a history of the mass being present and changing in size over time, mostly due to the release of histamine that
causes local swelling. Staging for this cancer often involves blood work, lymph node aspirates, chest radiographs, and
abdominal ultrasound to ensure there is no evidence of internal cancer spread.
Most MCTs are associated with long-term survival after surgical excision, however, when surgery is not feasible due to
location, size, or owner preference, there is no true standard of care. Therefore, an effective treatment that can induce
regression on these tumors with minimal side effects is needed. In a recent pilot study in dogs treated with intra-tumoral
injections of human IL-2, there was a promising anti-MCT effect.
Purpose:
The purpose of this trial is to determine the efficacy and safety of the ALVAC IL-2 immunomodulator for the treatment of
cutaneous MCTs in dogs. All upon entry into the trial, patients will receive weekly intra-tumoral injections and then close
monitoring thereafter.
Eligibility:
- Clinical cases of measurable, cytologically-confirmed, cutaneous MCT (>1cm, <5cm).
- Written consent for entry to the trial from each dog’s owner, including consent for necropsy upon death from any reason
during the course of the study
Exclusion:
- Dogs with a significant co-morbid illness that, in the opinion of the investigator or sponsor, could compromise response to
the treatment, interfere with evaluation of its efficacy, or result in mortality within one year.
- Dogs having received previous immunotherapy
- Concurrent medications deemed incongruent with this study. Prednisone is allowed only if the patient was previously
receiving and experienced tumor progression while on prednisone.
- Dogs in the care of owners/designee living at a distance from the treatment center that in the opinion of the investigator
will make compliance with follow-up incompatible with reasonable travel arrangements.
Financial Incentive:
This study is partially funded and will cover most of the cost for staging (blood work, cytology, consultation) and
subsequent weekly study treatments (exam and blood work). Upon completion of the study, owners are also provided some
financial incentive to help defray the cost of either surgery or additional therapies.
Study #2: Evaluation of novel immunotherapy
Location: Hope Veterinary Specialists-Malvern, Pennsylvania
Study Contact: 610-296-2099 or oncology@hopevs.com
http://hopevs.com/specialties/clinical-trials/lymphoma-melanoma-mast-cell-tumors/
Summary:
This trial is designed to evaluate the safety and preliminary anti-cancer activity of a novel, monoclonal antibody in dogs
with measurable cancer. The antibody is administered IV by the study staff every 28 days for up to 5 treatments. There is
no placebo in this trial. An estimated 30 client-owned dogs with Lymphoma, Melanoma, or Mast Cell Tumors will be
enrolled. Visits will be required when the dogs begin the study, at Day 14, Day 28, and monthly thereafter for a total trial
period of 140 days.
Eligibility:
At least one measurable skin tumor +/- metastatic lymph node(s) > 2 cm
No intraabdominal metastasis
Prior therapy accepted with washout times to be discussed with the participating site
Financial Incentive:
The trial is fully funded for the full trial duration (140 days), including the antibody and trial-related procedures.
VIRGINIA
Study: The impact of neoadjuvant prednisone on grade and proliferation indices in canine cutaneous
mast cell tumors: A pilot study
Location: Virginia-Maryland Regional College of Veterinary Medicine-Blacksburg, Virginia
Study Contact: Mindy Quigley at vettrials@vt.edu or 1-540-231-1363
www.vetmed.vt.edu/clinical-trials/current-studies/mastcell.asp
Purpose:
To determine if administering prednisone prior to surgery affects the factors used to define the grade of mast cell tumors,
and thus potentially affects prognosis and treatment recommendations.
Background
Mast cell tumors are the most common malignant skin tumor in dogs. The prognosis is highly-dependent upon the tumor
grade, which can only be determined by histopathology (biopsy). For low-grade tumors, complete surgical removal is
curative. However, nearly 100% of dogs with high-grade tumors will succumb to their disease within 6 months to a year of
diagnosis. Treatment with prednisone is an effective treatment as sole therapy. It is also used prior to surgery to shrink the
tumor or as part of a chemotherapy protocol used in dogs with high-grade tumors. However, it is unknown how the use of
prednisone prior to surgery affects the factors used to define the tumor grade, which has potential to impact the prognosis
and recommended further treatment options.
Eligibility
Cytological diagnosis of cutaneous mast cell tumor
Body weight > 5kgTumor size of between 1 and 10 cm in diameter
Exclusion Criteria
Previous therapy to current tumor including chemotherapy, corticosteroids, tyrosine kinase inhibitors, or radiation.
(Recurrent tumor is acceptable, H1 and H2 blocking agents are acceptable).
Evidence of concurrent significant biochemical or hematological abnormalities
Study Design
All dogs will undergo a complete physical exam, lab work, and fine needle aspirate cytology of the tumor. If a definitive
diagnosis of mast cell tumor is obtained and other criteria are met, eligible dogs will be offered the opportunity to enroll in
the study. Within 7 days of enrollment, we will obtain a small incisional biopsy of the tumor and perform histopathological
tumor evaluation and determination of proliferation indices levels. You will then administer at-home treatment with daily
prednisone for 10-14 days. Following prednisone treatment, your pet will undergo surgical removal of the mast cell tumor.
The tumor will be submitted for diagnosis, tumor grading, and measurement. Once your pet is discharged from surgery,
your participation in the study is completed. After biopsy results are finalized, you will receive a phone call informing you of
these results. You will also receive recommendations for further tests or treatments by our Board-certified Veterinary
Oncologists. There is no obligation to pursue any further testing or treatment.
Compensation
Once the dog is deemed eligible and informed consent is obtained, the study will cover the expenses for the pre-treatment
biopsy, the prednisone treatment, and $1,000 towards the cost of surgery. This compensation will only partially cover the
cost surgical removal. Typical cost of a skin mass removal in the Veterinary Teaching Hospital is $1,800-2,200. You are
responsible for any other clinical fees associated with the screening procedures, surgery, any identified concurrent
medical issues, or complications associated with surgery.