Clinical trials for dogs with cancer.

CALIFORNIA
Study: Nanoparticle taxol for the treatment of dogs with various tumor types (except lymphoma)
Location: University of California Veterinary Hospital, Davis, CA
Phone: 530.752.0125
www.vetmed.ucdavis.edu/vmth/small_animal/oncology/studies.cfm

Study: Intratumoral concentrations of enrofloxacin and its metabolite ciprofloxacin in spontaneously
arising canine tumors
Location: University of California Veterinary Hospital, Davis, CA
Phone: 530.752.0125
www.vetmed.ucdavis.edu/vmth/small_animal/oncology/studies.cfm

Eligibility: 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

Summary: 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.

Requirements and incentives: 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.

COLORADO
Study: Metronomic cyclophosphamide combined with carboplatin for dogs with cancer.
Location: Colorado State University Animal Cancer Center, Fort Collins, CO
Phone:    970-297-4195
www.csuanimalcancercenter.org/metro-carboplatin

Study: Hydroxychloroquine to enhance doxorubicin effectiveness.
Location: Colorado State University Animal Cancer Center, Fort Collins, CO
Phone:    970-297-4195
www.csuanimalcancercenter.org/hydro-doxorubicin

Eligibility: Dogs with any type of measurable cancer are eligible for this study. Dogs must undergo some diagnostic testing
prior to starting the study to ensure that they are eligible (bloodwork, x-rays, +/- ultrasound, +/- tumor biopsy). They must
have good function of the liver and kidneys and acceptable blood cell counts. No concurrent cancer therapy can be given
during the study, and a 3-week washout from prior chemotherapy and 6-week washout from prior radiation therapy is
required. Owners must consent to a post-mortem examination (autopsy) at the time their pet dies or is euthanized.

Purpose: This clinical trial is designed to evaluate a form of treatment for dogs with cancer using a combination of the
antimalarial drug hydroxychloroquine (HCQ) and the chemotherapy agent doxorubicin (DOX). Recent studies suggest that
HCQ can sensitize human tumor cells to the anti-cancer effect of DOX. Recent studies in dogs with skin disease have
demonstrated that long-term HCQ treatment appears to be well-tolerated. The combination of these two treatments has
not been explored in canine cancer patients. The goal of this study is to determine the maximum tolerated dose of HCQ
that can be administered to tumor-bearing dogs when followed by a standard dose of DOX.

Owner's responsibilities: The owner is responsible for scheduling appointments with the oncology clinical trials coordinator
and keeping those appointments as required by study protocol. The owner is responsible for the costs of diagnosis and
staging of the tumor prior to entering the study.

Financial Incentive: Clients participating in this study will be given special financial considerations. Specifically, the study
will pay for many of the costs associated with the study, including recheck examinations, tumor biopsies for the study, and
study-related blood tests. The HCQ and DOX are also provided at no cost. The costs of DOX administration and recheck
imaging tests such as x-rays or ultrasound, if necessary to determine treatment effectiveness, are the responsibility of the
owners.

FLORIDA
Study: Diagnostic Scan for Dogs with Solid Tumor Type Cancer
Location: University of Florida
Phone: 352-392-2235 or Dr. Rowan Milner at milnerr@ufl.edu
http://research.vetmed.ufl.edu/clinical-trials/small-animal/diagnostic-scan-for-cancer-in-dogs/

The University of Florida College of Veterinary Medicine is currently recruiting dogs recently diagnosed with cancer for a
clinical research trial. This investigational trial is for the development of a future diagnostic imaging and drug delivery
system.

Eligibility: Any dog recently diagnosed with cancer. All solid tumors will be considered that have not been surgically
removed.

Summary: The University of Florida is developing a unique method for delivering therapy to the tumor areas of dogs. This
method uses a polymer that has been made at UF to target tumor cells. A polymer is a string of molecules connected
together, like how plastic is made. This first study is testing the polymer drug delivery system to see if it attaches to your
dog’s tumor and to see if it attaches to other areas of the body that could also be cancer that has spread. There is no drug
attached to the polymer for this study.   This polymer is water soluble and the body should process it normally. Attached to
this polymer is a radionuclide. A radionuclide is a chemical that can concentrate in certain tissues or organs and emit
gamma rays that can be measured with a camera. Radioactive Iodine to test the tisses in a thyroid gland is an example of
a common medical practice where this technique is used. For this styudy, the radionuclide allows us to see where the
polymer goes inside the body when we take pictures of the body using a special scanner. Blood and urine will be collected
throughout the duration of the study. This is not a cancer treatment study. Your dog will be available to further cancer
therapies after 24 hours.

Dogs will be dosed with a diagnostic radionuclide polymer and scanned with a machine that will take a picture of affected
areas to determine where in the body the drug went. This is not a treatment study. Dogs will be released from the trial and
be available for surgery or further cancer therapy after 24 hours.

Financial incentive: A $200 credit will be provided towards your bill for diagnosis or imaging.

GEORGIA
Study: Phase I clinical trial of 5-fluorouracil in tumor-bearing dogs
Location: University of Georgia, Athens, GA
For more information, please contact Dr. Corey Saba, Dr. Jessica Lawrence, or Dr. Nicole Northrup at 1-(800)-861-7456,
locally at (706) 542-5362

Eligibility:

Dogs must be otherwise healthy, have adequate bone marrow and organ function, and weigh > 10.0 kg
They may have measurable or microscopic disease to participate.
They may have had prior surgery, radiotherapy, and/or chemotherapy. However, there must be at least a four week
lapse between any of these treatments and trial entry.
Dogs may not receive non-steroidal anti-inflammatory drugs (NSAIDs) while in the study and must undergo a 72 hour
washout period if on NSAIDs prior to study initiation.
Treatment with prednisone is permissible if indicated for the dog’s disease process.
Owners must sign a consent form.

Summary: 5-fluoropyrimidime antimetabolite drugs such as 5-fluoruracil (5-FU) are primarily used in human oncology to
treat epithelial tumors. Although 5-FU has been used to treat cancer in dogs, its dosage, treatment schedule, and
toxicities have never been appropriately investigated. The objectives of this study are to determine the maximum tolerated
dosage, to establish a safe starting dosage, and to determine treatment-related side effects of 5-FU in dogs with cancer.
Dogs must have a confirmed diagnosis of malignant cancer to be eligible for participation in this study.

Requirements and Incentives: Dogs will undergo preliminary staging tests including initial consultation and physical
examination, complete blood count (CBC), serum biochemical profile, and urinalysis to determine trial eligibility. Once
accepted into the study, the intent will be to administer escalating dosages of 5-FU to each dog at weekly intervals for up to
four treatments total. A CBC will be rechecked prior to each treatment. Additionally, blood will be collected prior to the
first treatment to determine 5-FU clearance.

Owners will be responsible for the costs of all office visits, the initial staging, and any related medications or diagnostic
tests. The costs of lab work (follow-up CBCs, biochemical profile, and 5-FU clearance samples), up to four 5-FU treatments
and associated chemotherapy administration fees will be paid by the study if the dog qualifies. Assuming the dog tolerates
the first four treatments well, treatments may be continued, off study, at the owner’s expense. Up to $500 is budgeted per
dog to treat severe complications of treatment (should they occur). Any costs greater than $500 will be the owner’s
responsibility.

MISSOURI
Study: CTI-52010 as therapy for dogs with cancer
Location: Missouri University Veterinary Medical Teaching Hospital, Columbia, MO
Phone: 573-882-7821 (Dr.Kim Selting)
www.cvm.missouri.edu/oncology/current.html

Eligibility:

Any tumor except OSA including lymphoma confirmed by histopathology or cytology
Normal CBC, renal and liver function, UA and thoracic radiographs at first visit.
28 day washout from last chemotherapy
Patient must weigh over 10 kgs

Summary: CTI-52010 is a new nanoparticle taxane drug that has been developed to avoid the allergic reactions of earlier
taxanes. It has already been shown to be safe in normal dogs. This clinical trial will refine the proper dosage for dogs with
cancer and determine whether there is evidence of efficacy.

Therapy:
CTI-52010 every 3 weeks for a total of 4 treatments
CBC, chemistry panel, UA on days 0, 7, 21, 28, 42, 49, 63 and 70. Thoracic radiographs on day 0 and 63, then every 2
months thereafter. Visits also on days 14, 35, 56 and 77.

Requirements and Financial Incentives: Once enrolled study is fully funded. Treatment includes: free drug and drug
administration, hospitalization for 1st night, blood work, imaging (rads & U/S) and office calls. Initial workup is owner’s
responsibility.

OHIO
Study: Compassionate use of KPT-335 in dogs with Spontaneous Cancer
Location: Ohio State University College of Veterinary Medicine, Columbus, OH
Contact: Nicole Stingle or Tamra Mathie at clinicaltrials@cvm.osu.edu
http://vet.osu.edu/vmc/compassionate-use-kpt-335-dogs-spontaneous-cancer

Eligibility: To qualify for enrollment in this study, dogs must have:

Dogs diagnosed with lymphoma, mast cell tumor, osteosarcoma, or melanoma. The patient may have failed standard
therapy or there may be no other known effective antineoplastic therapeutic options, or the owner may elect to enter
the patient in lieu of standard therapy.
Dogs must be at least 1 year of age.
Adequate organ function as indicated by standard laboratory tests
Dogs must have an estimated life expectancy of at least 28 days.
Prior chemotherapy or radiation must be completed at least 2 weeks prior
Owner must be able to orally administer drug according to designated schedule
No evidence of brain metastasis
Can not be less than 2 weeks from a major surgical procedure

Background: In both normal and cancerous cells, proteins important in regulating cell growth and survival regularly move
between the cell cytoplasm and the nucleus (center) of the cell. This shuttling of proteins is tightly controlled and helps to
decide which genes get turned on and which genes get turned off. It is known that a specific protein in the membrane of
the nucleus, CRM1, controls the shuttling of several key proteins in and out of the nucleus. In fact, over 150 proteins have
been found to use CRM1 to leave the nucleus of the cell and enter the cytoplasm. In cancer cells, the function of CRM1 is
critical to maintaining the uncontrolled growth and survival of these cells. Recent studies indicate that blocking CRM1 can
induce death of cancer cells as they cannot recover function when the shuttling of proteins is disrupted; in contrast, normal
cells appear to be less sensitive to this effect, likely because they are not growing in an uncontrolled manner. The novel
compound KPT-335 is an irreversible inhibitor of CRM1; that is, once it binds, CRM1 cannot function unless new CRM1
protein is made. Studies in the laboratory have shown that KPT-335 kills a variety of cancer cell lines, even those known
to be resistant to chemotherapy. KPT-335 has also demonstrated activity in mouse models of cancer when given by
injection under the skin or orally. KPT-335 has also been tested in normal dogs where doses of 3-5 mg/kg were given
Monday, Wednesday, Friday (MWF). Mild vomiting, diarrhea, and appetite loss did occur; this recovered with the addition
of canned food to the diet and supportive care. In doses above 58 mg/kg, elevations in liver values were observed,
although they recovered with discontinuation of drug and the use of a lower dose.

Summary: Patients will be screened for eligibility, if enrolled dogs will be administered KPT-335 orally (PO) Monday and
Thursday of each 7 day cycle for a total of 4 cycles. Drug will be administered on an empty stomach by the owner at home
at the same time each morning. Patients will need to return on Weeks 1, 2, 3, and 4. On these days, the patient will need
to arrive with in 2 hours of administering medication for blood levels and blood work. Dogs who respond to KPT-335
treatment with an objective response (CR or PR) or stable disease (SD) according to predefined criteria may continue to
receive cycles of KPT-335 indefinitely, as long as DLT is not observed. Dogs that miss more than 1 dose of a cycle for
toxicity may have their dose reduced by 1 level. Any dog requiring a delay in dosing of more than 48 hours due to drug
toxicity will also have its dose reduced by 1 level. Patients requiring a dose delay of more than 2 weeks for toxicity
possibly, probably, or definitely related to protocol-based therapy will be removed from the study. If a dose is missed or
the entire dose is not given, the dose will not be made up.

Financial Incentive: The sponsor will cover study associated costs for screening, exam fees, labwork and upto $750 for any
adverse events.