ARIZONA
Study: MAX-1/Doxorubicin Combination Therapy for Doxorubicin Resistant Lymphoma in Dogs
Location:  Southern Arizona Veterinary Specialty & Emergency Center, Tuscon, AZ
Phone:     1-877-762-9838 OR 520-888-3177
www.southernazvets.com/research-at-savsec.html

Summary: Study covers the cost of the doxorubicin drug costs and MAX-1. The owner remains responsible for visits,
laboratory work and administration costs

NORTHERN CALIFORNIA
Study: Bioavailability and Safety of a Canine Lymphoma Monoclonal Antibody Administered
Intravenously to Dogs with T-cell Lymphoma
Location:  University of California Veterinary Hospital Davis, CA
Phone:     Teri Guerrero (530-752-0125 or tguerrero@ucdavis.edu)
www.vetmed.ucdavis.edu/clinicaltrials/current_trials/dogs.cfm

Purpose: Lymphoma is one of the most common blood cancers affecting dogs of different type of breeds and ages with no
known cure. Current treatments involve the use of extensive chemotherapy and/or associated radiotherapy, all of which
may have side effects that could negatively impact your dog's quality of life. The antibody being used in this study is
designed specifically for dogs to potentially treat lymphoma and was shown to be safe and effective at depleting lymphoma
cells in laboratory studies. Antibodies are non-chemotherapeutic agents that were first used for treating lymphoma in
humans. In fact, antibodies extended survival time and improved quality of life while significantly reducing toxicity in humans.

Eligibility: Dogs diagnosed with T-cell lymphoma that:

  • Are naïve to treatment
  • Have owners who have refused conventional treatment (surgery, radiation therapy, chemotherapy)

Procedures:
Upon entry into the trial: The dog will undergo a physical exam and 2 lymph nodes will be measured.

First visit: Blood (1 tsp) will be drawn to measure the amount of the antibody in the blood and analyze lymphocyte
population distribution. Aspirates of one lymph node will be obtained (for staining for absence or presence of the antibody).
A catheter will be placed in a peripheral vein and the antibody will be administered by infusion over 10 minutes. The dog
will be closely observed for 45 minutes to make sure that there are no allergic reactions. If there is an allergic reaction,
dexamethasone (0.2mg/kg IV) and diphenydramine (2 mg/kg SQ) will be administered. Additional blood (1 tsp) will be
drawn at 1, 4, 8, 24 and 48 hours (this visit corresponds with the second visit) after infusion.

Second visit: Blood (1 tsp) and lymph node aspirates will be obtained and target lymph nodes will be measured. Another
dose of the antibody will be administered and the dog monitored as above. You can take your pet home after this visit.

Second, third, and fourth week: Your dog must come in twice weekly for infusions, measurement of lymph node size, blood
draws (1 tsp each time), lymph node aspirates, and a physical exam.

At the completion of the first month of twice weekly therapy: IF there is response or stable disease AND the dog is feeling
well, infusions can continue (once every 2-4 weeks, depending on the level of the antibody in the blood) for an additional 4
treatments.

At the completion of 4 treatments or 4 months of therapy (which ever comes first), you can elect to do nothing more or
discuss starting prednisone, standard of care (if naïve), additional chemotherapy or comfort care (if refractory).

Benefits: While the exact benefits of this antibody are not entirely known, it may benefit your dog by shrinking his/her
cancer, and/or by keeping your dog cancer-free for a longer period of time

Financal Incentives: There is no cost for the antibody, but you will be responsible for the cost of the initial physical
examination, initial blood work (prior to enrollment), management of possible side effects, and necessary staging tests.

Study: The Effect of IV Infusion of Doxorubicin on the Incidence of Cardiac Arrhythmias and Cardiac
Troponin I Levels in Dogs
Location:  University of California Veterinary Hospital Davis, CA
Phone:     Teri Guerrero (530-752-0125 or tguerrero@ucdavis.edu)
www.vetmed.ucdavis.edu/clinicaltrials/current_trials/dogs.cfm

Purpose: 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.

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

Ineligible:
No evidence of pre-existing cardiomyopathy
Previous history of arrhythmia
Currently receiving anti-arrhythmic therapy
Previous history of thoracic radiation therapy

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.

Financial Incentives: 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.


COLORADO
Study #1: Monoclonal Antibody Therapy of Canine B-cell Lymphoma
Location: Colorado State University Animal Cancer Center, Fort Collins, CO
Phone:    970-297-4195
www.csuanimalcancercenter.org/evaluation-of-a-novel-monoclonal-antibody-in-combination-with-chop-chemotherapy-for-t-
cell-canine-lymphoma

Eligibility: Dogs with suspected B cell lymphoma may be eligible for the study. Dogs should be otherwise in good health and
must have adequate organ function as determined by blood work and urinalysis. To determine eligibility, some of your dog’
s tumor cells will first be collected through a needle aspirate of an enlarged lymph node. The cells will be examined to
confirm that your dog has B cell lymphoma (rather than T cell) and tested to see if the antibody will recognize your dog’s
tumor cells. Previous treatment is allowable provided that dogs have not received any chemotherapy or radiation therapy
in the previous 1 week or corticosteroids in the previous 72 hours.

Summary: CSU is investigating whether an antibody that specifically targets a particular receptor on the surface of
malignant B cells could be used to treat dogs with B cell (non-Hodgkin’s) lymphoma. Many types of lymphoma have this
receptor on their surface at high levels, a property that makes them stand out from normal immune cells in the body. An
antibody targeting this receptor (known as IMMU-114) has recently been developed and is being investigated as a possible
new treatment for both humans and dogs with B cell lymphoma. CSU tested this antibody in normal, healthy dogs and
found that it is safe as long as it is given slowly as an intravenous infusion during an overnight hospital stay. CSU is now
ready to begin evaluating the antibody in dogs with lymphoma to evaluate its potential efficacy in treating this common
disease.

Requirements: You are responsible for the cost of the diagnostic tests required to determine your pet’s eligibility, include
cytology of a lymph node aspirate and blood work and urinalysis. You are expected to make and keep all appointments
according to the study protocol and all other costs once the study has been completed.

Financial incentive: Clients participating in this clinical trial will be given special financial considerations. Once your dog has
qualified for this trial, the study will pay for immunophenotyping to determine if B-cell lymphoma, recheck blood work
(complete blood count and biochemical profile) and urinalysis, and hospitalization directly associated with antibody
administration. The cost to treat any side effects related to the antibody treatment that occur within 7 days after the
antibody was given will be covered by the study. In addition, a $400 credit which will be applied to your pet’s account at the
CSU Veterinary Teaching Hospital.

Study #2: Efficacy of Tanovea (Rabacfosadine) for Injection in Dogs with Lymphoma
Location: Colorado State University Animal Cancer Center, Fort Collins, CO
Phone:    970-297-4195
www.csuanimalcancercenter.org/efficacy-of-tanovea-rabacfosadine-for-injection-in-dogs-with-lymphoma

Eligibility: Dogs with confirmed lymphoma 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, chemistry profile) and
urinalysis. Chest X-rays are strongly recommended.  Dogs must have good function of liver and kidneys, have acceptable
blood cell counts, and be free of severe underlying disease.  

Summary: Lymphoma is one of the most common cancers in dogs.  Current treatment options include various types of
chemotherapy; however, there are no approved drugs for lymphoma in dogs, very few dogs are cured and most will
relapse.  New drugs remain necessary to treat these drug-resistant relapses.

Tanovea (Rabacfosadine) is an intravenous chemotherapy agent that has been used both in normal dogs and in more
than 80 dogs with cancer.  It has been shown to induce remission in 60 to 100% of dogs with lymphoma.  The goal of this
study is to evaluate the effectiveness of Tanovea (Rabacfosadine) given once every 21 days.

Requirements: Initially your pet will undergo a series of diagnostic tests, which may include blood tests, urinalysis, a fine
needle aspirate of a representative lymph node, and chest X-rays.  The results of these initial tests will determine if your
pet is eligible to enter this clinical trial.  These tests are part of the routine testing done in patients with lymphoma, and may
be performed even if you decide that your pet will not participate.  Your dog will then receive an injection of Tanovea
(Rabacfosadine) every 3 weeks for up to 5 treatments.  Rechecks will be required 1 week after the first treatment, and
possibly 1 week following the second treatment, depending on whether side effects are noted or not.  This study is not
randomized and there is no placebo group – all dogs will receive Tanovea  (Rabacfosadine).

Your pet may experience side effects.  Side effects may be mild or serious, including the risk of death.  Treatment with
Tanovea (Rabacfosadine) may result in gastrointestinal upset (decreased appetite, vomiting, diarrhea) and decreases in
the white blood cell count.  Tanovea (Rabacfosadine) may also cause hair loss, skin reddening, itchiness and pain after
multiple doses.  These effects go away when treatment with Tanovea (Rabacfosadine) is stopped.  A small number of dogs
have developed scarring of the lungs after completion of treatment.  Everyone involved in your pet’s care will monitor
carefully for side effects.  Your pet’s oncology clinician may prescribe medications, delay treatment or reduce the dosage
of Tanovea (Rabacfosadine) to help lessen side effects.

Your pet’s oncology clinician will discuss possible side effects with you.  If your pet experiences anything unusual during
the clinical trial, please contact the oncology clinician or Clinical Trials team.

Owner Responsibilities: You are expected to make and keep all appointments according to the study protocol.  You must
be comfortable administering oral medications at home, and you must be committed to completing the entire study protocol
and follow-up examinations.

Financial incentive: Clients participating in this study will be given special financial considerations.  Rabacfosadine will be
provided at no cost.  You will be responsible for the costs of the initial examination and tests to insure eligibility to
participate, the recheck examinations, blood tests, and ancillary medications.

Study #3: Comparison of Three Indenoisoquinolines Candidates in Tumor-Bearing Dogs
Location: Colorado State University Animal Cancer Center, Fort Collins, CO
Phone:    970-297-4195
www.csuanimalcancercenter.org/indenoisoquinolines_tumor_bearing_dogs

Eligibility: Dogs with confirmed diagnosis of lymphoma with at least one lymph node 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.

Summary: 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.
This trial is divided into 2 phases of which enrolled dogs 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.

Procedures: Within this study, dogs will receive daily intravenous administration of an indenoisoquinoline for 5 consecutive
days. This requires placement of a central line catheter into the dog's neck and serial collections to allow for
measurements of drug levels within his/her blood. 24-hour blood collections are linked to the 1st and 5th day of drug
dosing. Therefore the first week of therapy will require overnight boarding at the VTH for up to 5 days. The required
number of nights to board will be determined by the attending clinician prior to enrollment. Lymph node biopsies will be
performed prior to treatment and on day 1 after the first dose of chemotherapy and a lymph node will be removed on day 6
of the study. Bone marrow aspirates will be performed prior to treatment and on day 6 as well. Each of these biopsies and
bone marrow aspirations will occur under anesthesia, either local (sedation with anesthetic) or general. Subsequently the
dog will return 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.

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.

Financial incentive: 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 the dog's account at the CSU
Veterinary Teaching Hospital which can be used for further treatment.

Study #4: EZN-3042 in Canine Lymphoma
Location: Colorado State University Animal Cancer Center, Fort Collins, CO
Phone:    970-297-4195
www.csuanimalcancercenter.org/ezn-3042-canine-lymphoma

Eligibility: Dogs with confirmed lymphoma 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, chemistry profile) and
urinalysis. Dogs must have good function of liver and kidneys, have acceptable blood cell counts, and be free of severe
underlying disease.

Summary: Lymphoma is one of the most common cancers in dogs. Current treatment options include various types of
chemotherapy; however, there are no approved drugs for lymphoma in dogs, very few dogs are cured and most will
relapse. New drugs remain necessary to treat these drug-resistant relapses.

Survivin is a protein that is very important in cancer cell growth and survival. We have demonstrated that dog lymphomas
express survivin, and that high survivin levels are associated with a worse outcome after chemotherapy. EZN-3042 is a
form of gene therapy that targets survivin and reduces survivin protein in cancer cells. EZN-3042 reduces survivin levels in
canine cancer cells, resulting in reduced growth and enhanced cell death. EZN-3042 has not been evaluated in dogs. The
goal of this study is to determine whether EZN-3042 is capable of reducing survivin levels in dog lymphoma tissue at doses
that are well tolerated in dogs.

Procedures: If your dog is deemed eligible for the trial, a biopsy of a representative lymph node will be obtained. Your dog
will then receive 3 intravenous infusions of EZN-3042 over 1 week, with a second tumor biopsy 24 hours following the last
EZN-3042 injection. After the second biopsy, the study is complete and dogs are eligible to receive any additional therapy
recommended by your veterinarian. This study is not randomized and there is no placebo group - all dogs will receive EZN-
3042.

Your pet may experience side effects. Side effects may be mild or serious, including the risk of death. Although EZN-3042
has been extensively evaluated in mice, monkeys and humans, it has not been evaluated in either normal dogs or dogs
with cancer. In humans, the most common side effects are reversible fatigue, changes in blood cell counts or changes in
liver values. Everyone involved in your pet's care will monitor carefully for side effects. Your pet's oncology clinician may
prescribe medications, delay treatment or reduce the dosage of EZN-3042 to help lessen side effects.

The trial will last 8 days. Following completion of the trial, your dog will then be eligible for any other therapy your oncology
clinician deems appropriate.

Owner Responsibilities: You are expected to make and keep all appointments according to the study protocol. You must be
committed to completing the entire study protocol and follow-up examinations.

Financial incentive: Clients participating in this study will be given special financial considerations. EZN-3042 will be
provided at no cost. Once enrolled, all tests associated with performance of the trial, including blood and urine tests and
biopsies, are covered by the study. In addition upon completion of the study, a $750 credit will be applied to the pet's
account at the Veterinary Teaching Hospital which can be applied to future treatment.

Study #5: VDC-597 for Treatment of Canine B-Cell Lymphoma
Location: Colorado State University Animal Cancer Center, Fort Collins, CO
Phone:    970-297-4195
www.csuanimalcancercenter.org/canine-b-cell-lymphoma

Eligibility: Dogs with confirmed lymphoma 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, chemistry profile), urinalysis,
chest X-rays and bone marrow aspirate. Dogs must have good function of liver and kidneys, have acceptable blood cell
counts, and be free of severe underlying disease. Participating dogs must have lymphoma determined to be B-cell in origin.

Summary: Lymphoma is one of the most common cancers in dogs. Current treatment options include various types of
chemotherapy; however, there are no approved drugs for lymphoma in dogs, very few dogs are cured and most will
relapse. New drugs remain necessary to treat these drug-resistant relapses.

VDC-597 is an oral agent that has been used both in normal dogs and in humans with cancer. It works by inhibiting the
function of proteins in certain cells that are necessary for cell growth and prevention of cell death. These proteins seem to
be more important in certain kinds of cancer than in normal cells. VDC-597 has been shown to inhibit the growth of canine
lymphoma cells in the laboratory, and has been shown to be safe in normal dogs. The goal of this study is to evaluate the
safety of VDC-597 given by mouth every day, and to determine the best dose of VDC-597 to be used in future studies.

Procedures: Initially your pet will undergo a series of diagnostic tests, which may include blood tests, urinalysis, a fine
needle aspirate of a representative lymph node, chest X-rays and a bone marrow aspirate. A biopsy of a lymphoma-
containing lymph node will also be performed. The results of these initial tests will determine if your pet is eligible to enter
this clinical trial. These tests are part of the routine testing done in patients with lymphoma, and may be performed even if
you decide that your pet will not participate. Your dog will then receive daily VDC-597 by mouth. The first dose will be given
in the hospital and multiple blood samples taken to measure drug levels in the blood. Rechecks will be required weekly for
the first 4 weeks, then every other week thereafter. A second tumor biopsy will be performed 1 week after the drug is
started. Dogs are eligible to continue treatment with VDC-597 as long as their tumors are the same size or smaller and no
serious toxicity has been observed. This study is not randomized and there is no placebo group - all dogs will receive VDC-
597.

Owner Responsibilities: You are expected to make and keep all appointments according to the study protocol. You must be
comfortable administering oral medications at home, and you must be committed to completing the entire study protocol
and follow-up examinations.

Financial incentive: Clients participating in this study will be given special financial considerations. VDC-597 will be
provided at no cost. You will be responsible for the costs of the initial examination and tests to insure eligibility to
participate. The costs of chest X-rays, bone marrow aspirate, biopsies and blood tests while receiving VDC-597 are
covered by the study. In addition, owners will receive $1,000 in the form of a CSU Veterinary Teaching Hospital credit,
which can be applied toward the cost of subsequent treatment.


INDIANA
Location: Purdue University Veterinary School of Medicine, West Lafayette, IN
Contact information:  Dr. Michael Childress at (765) 494-1107 or mochildr@purdue.edu, or you may contact Sarah
Lahrman at (765) 496-6289 or salahrma@purdue.edu
www.vet.purdue.edu/orpd/files/documents/clinical-trial-recruitments.pdf

Study #1: Use of new oral chemotherapy agent MLN0415
Description: This study involves the use of a new oral chemotherapy agent (MLN0415) which inhibits kappa B kinase(IKK);
known to contribute to cancer progression and drug resistance in human lymphomas. This pilot study is to determine
whether MLN0415 has activity against untreated or relapsed canine multicentric lymphoma.

Eligibility:
  • Biopsy confirmed high-grade multicentric lymphoma.
  • Measurable peripheral lymph nodes
  • Expected survival time of at least 4 weeks
  • Absence of significant symptoms of illness
  • Absence of other serious diseases.

Financial incentive: MLN0415 will be provided at no charge.

Study #2: Dogs with lymphoma that have failed or relapsed following treatment
Description: The purpose of this pilot study is to assess the anti-tumor efficacy of carboplatin in dogs that have failed or
relapsed following treatment of at least 1 other chemotherapy protocol

Eligibility:
  • Biopsy –confirmed high-grade multicentric lymphoma
  • Cancer relapse following treatment
  • Expected survival ≥ 4 weeks
  • Normal CBC and serum creatinine ≤2 mg/dl

Financial incentive: Carboplatin drug and tru-cut biopsy cost covered by research funds.


Study #3: Dogs with lymphoma
Description: This multi-institutional trial, sponsored by the National Cancer Institute, assesses the safety and effectiveness
of three newly developed chemotherapy agents when given to dogs with lymphoma.

Eligibility:
  • Biopsy diagnosis of lymphoma
  • Absence of clinical signs of illness
  • Both newly diagnosed and relapsed lymphomas are eligible

Financial incentive: Costs associated with this study will be provided. Additional financial support will be provided after your
dog’s completion of this study for chemoptherapy/treatment at the Veterinary Teaching Hospital.


LOUISIANA
Study: Mitoxantrone versus Mitoxantrone + DTIC for dogs with refractory lymphoma who were
previously treated with chemotherapy
Location: Louisiana State University School of Veterinary Medicine, Baton Rouge, LA 70803
Phone: 225-578-9600
www.vetmed.lsu.edu/clinical_trials.htm

Eligibility: To be eligible for this study, your dog must meet the following criteria: confirmed diagnosis of lymphoma;
relapsed after initial treatment with CHOP chemotherapy (cyclophosphamide, doxorubicin, vincristine, prednisone), must
have never received mitoxantrone or DTIC chemotherapy and has not had chemotherapy for 14 days prior to initiating this
treatment.

Summary: The purpose of this study is to compare the efficacy of single-agent mitoxantrone to the combination of
mitoxantrone and DTIC, in dogs with CHOP-resistant lymphoma.


MASSACHUSETTS
Study #1: Investigation of IGF-1 axis in dogs with lymphoma
Location: Tufts University Cummings School of Veterinary Medicine, North Grafton, MA
Phone: Kelly Reed, Oncology Liaison; (508) 887-4682 or veterinaryoncology@tufts.edu
http://sites.tufts.edu/vetclinicaltrials/specialty/oncology/

Eligibility: Dogs with a confirmed diagnosis of multicentric lymphoma (cytology or pathology), weighing more than 25kg.
Dogs must be eating a commercial diet and be otherwise healthy.


Exclusion criteria: Dogs with other systemic diseases (diabetes mellitus, hypothyroidism, Cushing’s disease, kidney
disease, liver disease, etc). Dogs eating a home-cooked or raw diet.


Summary: Lymphoma is one of the most common cancers in the dog and is comparable to non-Hodgkin’s lymphoma in
humans. Chemotherapy is the standard of care for treatment and can provide long term disease control but survival
beyond 2 years is rare. There is active investigation into the utility of metabolic markers, such as insulin-like growth factor 1
(IGF-1), as a predictor of response to treatment in humans with non-Hodgkin’s lymphoma. Additionally these markers may
serve as a target for future therapy.
The goal of this study is to assess levels of IGF-1 and other related blood biomarkers
in canine patients with lymphoma. We will evaluate these markers for prognostic value and will determine whether they
could serve as targets for therapy in the future.

Requirement and incentive: No direct benefits. Dog owners are financially responsible for the costs associated with cancer
staging plus standard chemotherapy and recommended treatment monitoring (weekly complete blood counts).

This study covers the cost of measurement of IGF-1 and other metabolites.


Study #2: Novel Chemotherapy for Canine Multicentric Lymphoma
Location: Tufts University Cummings School of Veterinary Medicine, North Grafton, MA
Phone: Kelly Reed, Oncology Liaison; (508) 887-4682 or veterinaryoncology@tufts.edu
http://sites.tufts.edu/vetclinicaltrials/specialty/oncology/

Eligibility:
  • Dogs of any age
  • Cytologically or histologically confirmed diagnosis of lymphoma involving multiple external lymph nodes
  • Dogs must be feeling well or only minimally compromised
  • Dogs either must not have received treatment for lymphoma for at least 2 weeks prior to enrollment in the study

Exclusion Criteria:
  • Significant illness (such as kidney failure, liver disease, heart failure, severe anemia)
  • Dogs weighing less than 33 pounds
  • Dogs who have received prednisone for any reason in the two weeks prior to study enrollment

Summary: This preclinical trial, sponsored by the National Cancer Institute, is designed to evaluate three new
chemotherapy agents in the indenoisoquinoline class. These drugs inhibit topoisomerase I, which is an enzyme important
in DNA replication, and have shown efficacy in a variety of cancers.

The intent of this study is to define and compare the pharmacologic effects of these three drugs in dogs with lymphoma.
Specifically, the study will assess basic properties of the drug, such as duration of action, markers of damage to DNA in
cancer cells, and safety. The goal is to determine the appropriate dose of each drug and to determine if there are
differences in biologic activity among the drugs. The response to treatment, specifically whether lymphoma goes into
remission in the treated dogs, will also be assessed.

Financial incentive: This study is fully funded and will cover the cost of treatment, monitoring tests and management of
treatment related side effects. Dogs that complete the 28-day study will be eligible to receive $1000 for further medical
care at Tufts.

Study #3: Investigation of a novel diet for support of dogs undergoing chemotherapy for mast cell
tumors or multicentric lymphoma
Location: Tufts University Cummings School of Veterinary Medicine, North Grafton, MA
Phone: To make an appointment with the oncology department please call the oncology liason, Kelly Reed at 508-887-
4682
. For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at: diane.welsh@tufts.
edu

http://sites.tufts.edu/vetclinicaltrials/specialty/oncology/

Eligibility: ◾Dogs > 1 year of age with multicentric lymphoma (LSA) and grade 2 or higher mast cell tumors (MCT) that will
be treated with standard (non-metronomic) chemotherapy protocols at a participating study site.
◾Weight > 5 kg,
temperament suitable for drawing blood without sedation, All dogs should be naïve to treatment for the current cancer, but
can have been treated for other cancers in the past if greater than 1 year prior.

Exclusion criteria: Other diseases expected to potentially decrease quality of life, alter survival time, or limit diet options – e.
g. significant heart disease, kidney disease, bad liver disease, etc.Current vomiting or diarrhea or a history of chronic
vomiting or diarrhea (more than 6 multi-day episodes per year or one month of consistent clinical signs) within the last year
that required medications or special diet for control. Dogs with anticipated life expectancy of < 4 months. Pet owner not
willing to feed prescribed diet and limit treats to 5% of calories.


Summary: Cancer is one of the most common conditions seen in older dogs and it is becoming more common for owners to
opt to treat their pets with chemotherapy.  Dogs undergoing chemotherapy may suffer from side effects of treatment such
as vomiting, diarrhea, and reduced appetite.  There are currently no commercial diets that are designed specifically to help
support dogs with cancer undergoing chemotherapy by reducing the gastrointestinal side effects of chemotherapy.The
purpose of the study is to determine whether a specially formulated diet may reduce gastrointestinal side effects
associated with chemotherapy and improve quality of life of dogs undergoing chemotherapy.


Dogs will be fed either a high quality control diet appropriate for dog maintenance or the specially designed study diet –
neither the pet owners nor the researchers will know which diet the dog is getting. Pet owners will need to fill out quality of
life surveys as well as diet journals and fecal score journals every 1-2 weeks, and bring their dogs in for study
visits/chemotherapy every 2 weeks. At three points during the study, blood and urine will be collected from fasted dogs.

Treats and dietary supplements will need to be restricted to only those provided on an approved treat and supplement list.


Financial incentive: The study will cover the costs of all study-related blood work and visits.  You will also receive free high
quality pet food for the two month study duration and a $300 credit towards your account balance when you and your dog
successfully complete the study and return all study-related paperwork.  The study does not include the costs of cancer
staging (including those required to determine study eligibility), or any costs associated with surgery or chemotherapy,
additional blood work not required for the study, or follow-up visits outside of those described above.  Your dog’s
participation will also allow us to gain information which will help in the management of other dogs undergoing
chemotherapy.


MISSOURI
Study #1: Relapsed Refractory Lymphoma/Chronic Lymphocytic Leukemia Study
Location: University of Missouri, Columbia, MO
Phone:    573-882-7821
www.cvm.missouri.edu/oncology/current.html

Eligibility:
  • Refractory lymphoma or chronic lymphocytic leukemia
  • CBC, chemistry panel, UA
  • RRL dogs: NO comorbid conditions that would limit life expectancy to <9 weeks. Adequate renal, hepatic and
    hematopoietic perimeters. Performance score of 0-1.
  • CLL dogs-included if: lymphocyte count > 40,000 cells/uL and < 150,000 cells/uL, normal liver and kidney values
    and performance score of 0 with life expectancy of 3 months.

Summary: Relapsed Refractory Lymphoma/Chronic Lymphocytic Leukemia Study is a study that involves the use of the
cholesterol inhibitor terbinafine as a chemosensitizer to dogs with relapsed refractory lymphoma (RRL) receiving lomustine
or dogs with chronic lymphocytic leukemia (CLL) receiving terbinafine alone followed by terbinafine and chlorambucil. The
specific objectives of this study are to demonstrate tolerability and improved efficacy of lomustine in managing RRL when
dogs are concomitantly treated with terbinafine, to identify activity of terbinafine alone in dogs with CLL, to demonstrate
improved efficacy of chlorambucil in managing CLL when dogs are concomitantly treated with terbinafine, and to
demonstrate lipid membrane composition changes in lymphocytes of dogs treated with terbinafine

Procedures:
  • RRL- Terbinafine daily throughout study starting 7 days prior to starting lomustine. Lomustine every three weeks.
    Complete blood work prior to and one week post lomustine treatment.
  • CCL- Terbinafine daily for two months prior to starting chlorambucil on days 1-4 of each treatment week. Complete
    blood work prior to and every 4 weeks after start of therapy.

Incentives: Drugs are provided free to owner.   

Study #2: Lymphoma-PET  Study
Location: University of Missouri, Columbia, MO
Phone:    573-882-7821 (Dr.’s Sandra Axiak and Mike Lewis)
www.cvm.missouri.edu/oncology/current.html

Eligibility:
  • Canine lymphoma diagnosed by cytology or histopathology
  • NO Prednisone prior to scan
  • CBC, chemistry panel, UA, thoracic and abdominal radiographs, abdominal U/S.
  • 18F-FDG-PET scan and overnight stay in radiation isolation
  • Bone marrow aspirate next day following PET scan

Overview: For humans with lymphoma, FDG positron emission tomography (18F-FDG-PET) has largely replaced CT
scanning to determine lymphoma stage for high-grade lymphomas, similar to those in dogs. In dogs, staging tests and
criteria have been inconsistently applied in the literature making precise prognostication difficult.  Replacing some or all of
the current staging procedures with a single, more sensitive procedure would improve standardization of stage
determination and potentially reduce expense and variability in test evaluation for dogs with lymphoma. The objective of
this project is to determine whether 18F-FDG-PET will perform equivalently with traditional staging tests for dogs with
lymphoma.

Incentives: PET scan and related charges provided free of charge. Initial staging is owner’s responsibility.


PENNSYLVANIA
Study: Comparison of Three New Medications for Dogs with Lymphoma
Location: University of Pennsylvania Veterinary Hospital, Philadelphia, PA
If you are interested in learning more about this study, please contact the VCIC at 215-573-0302 or vcic@vet.upenn.edu
www.vet.upenn.edu/research/clinical-trials/clinical-trial/comparison-of-three-new-medications-for-dogs-with-lymphoma

Summary: The purpose of this study is to determine the safety and dose of 3 different chemotherapy drugs in dogs with
lymphoma.  Dogs with a confirmed diagnosis of lymphoma (just diagnosed or relapsed after treatment) with no other
significant health problems are eligible.  Each dog will receive 1 of the 3 chemotherapy drugs being evaluated, and
depending on how your dog responds to the drug, additional doses may be given.  

Procedures: The chemotherapy drug is given daily for 5 days, and your dog will stay at Penn Vet during that treatment
period.  You will be required to bring your dog back to Penn Vet after the treatment is completed for a minimum of 28 days.

Benefits: Once your dog is enrolled, costs associated with study-related sample collection, treatment with the study drug
and any side effects will be paid for by the study.  Owners will also receive a financial credit to apply towards future non-
study lymphoma treatment for their dog.


WISCONSIN
Study #1: Dogs with lymphoma
Location:  University of Wisconsin Veterinary Teaching Hospital, Madison, WI
Phone:  Dr. Kathleen Tsimbas or members of the Oncology Service at (608) 263-7600.
http://uwveterinarycare.wisc.edu/clinical-trials/oncology/

Summary: One of the trials, sponsored by the National Cancer Institute (NCI), assesses the safety and effectiveness of
three newly developed chemotherapy agents (indenoisoquinolines) when given to dogs with lymphoma. Studies in mice
and non-tumor-bearing dogs have shown indenoisoquinolines to be safe.  The study involves intravenous administration of
an indenoisoquinoline daily for 5 consecutive days. Blood samples, bone marrow biopsies, and tumor biopsies will be
collected prior to treatment and following the first and fifth treatment. The first week of this study will necessitate a minimum
of 2 nights, if not all, overnight boarding at the Hospital. Dogs will then return weekly for evaluation and subsequent blood
collection (Day 8, 15, 22 and 29). Continuance on study beyond day 29 will be based on response to indenoisoquinoline
therapy. Costs associated with this study will be provided by the study. In addition, a gift of $1,000 (one thousand dollars)
will be credited to the owner’s UW Veterinary Care account. In the event any complications arise during the study period,
their management will be covered by study funds up to $2,000/per dog/per event. This would include any unanticipated
hospitalizations.

Study #2: Dogs with lymphoma
Location:  University of Wisconsin Veterinary Teaching Hospital, Madison, WI
Phone:  Dr. Kathleen Tsimbas or members of the Oncology Service at (608) 263-7600.
http://uwveterinarycare.wisc.edu/clinical-trials/oncology/

Summary: The second trial is evaluating a novel biological therapy for lymphoma.  This agent is administered directly into
an accessible lymph node, once weekly for 4 treatments. This study requires an initial hospital stay of 2 days, then weekly
visits until treatment is completed, and then follow-up visits every 2 weeks.  All costs associated with this study will be
provided by the study. In addition, a gift of $500 (five hundred dollars) will be credited to the owner’s UW Veterinary Care
account. In the event any complications arise during the study period, their management will be covered by study funds.
This would include any unanticipated hospitalizations.

Study #3: Dogs with lymphoma
Location:  University of Wisconsin Veterinary Teaching Hospital, Madison, WI
Phone:  Dr. Kathleen Tsimbas or members of the Oncology Service at (608) 263-7600.
http://uwveterinarycare.wisc.edu/clinical-trials/oncology/

Summary: The third trial is evaluating VDC-1101 (previously called GS-9219), which is an intravenous chemotherapy agent
that has been used both in normal dogs and in more than 80 dogs with cancer. It has been shown to induce remission in
60 to 100% of dogs with lymphoma. The goal of this study is to evaluate the effectiveness of VDC-1101 given
intravenously over 30 minutes, once every 21 days, along with a low dose of prednisone. VDC-1101 will be provided at no
charge. All costs related to drug administration, study evaluations, and management of adverse events will be paid for by
the owner.
PET CANCER CENTER
Comprehensive guide to cancer diagnosis and treatment in cats and dogs
© 2007 Pet Cancer Center. ALL RIGHTS RESERVED.
Last updated 10/5/2014
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