Oncology Clinical Trials

Dogs are helping scientists discover better cancer treatments

Learn more about Dr. Knapp's work in this wonderful story from WSB-TV!

A news team from Atlanta’s WSB-TV, an ABC-affiliate TV station, visited the Purdue University Veterinary Teaching Hospital recently to report on the game-changing possibilities of clinical trials involving naturally occurring cancer in dogs. In the full video, Anchor/Reporter Tom Regan described research led by Dr. Deborah Knapp, Dolores L. McCall Professor of Comparative Oncology and director of the Purdue Comparative Oncology Program (PCOP).  The story explained how comparative oncology research in dogs holds promise for speeding up the development of cancer-fighting drugs.

Current Clinical Trials

Canine Oral Squamous Cell Carcinoma

Pilot study involving a novel nanoparticle radiosensitizer in pet dogs with squamous cell carcinoma of the oral cavity

Investigators: Dr. Michael Childress, Dr. Jeannie Plantenga

Background:
Squamous cell carcinoma (SCC) is one of the most common tumors occurring in the oral cavity of dogs. Although it can be cured by surgical removal, curative surgery requires removal of portion of the upper or lower jaw bones. As a result, large SCC often cannot be cured surgically because removal of too much bone is required. Radiation therapy can be an effective therapy for SCC, but is only rarely curative. The purpose of this study is to determine whether injecting a new radiosensitizing nanoparticle drug into the tumor prior to radiation therapy will result in improved anti-cancer effects of radiation therapy. Results from this pilot study will help us to design follow-up studies in dogs and humans with SCC that cannot be cured surgically.

Eligibility for Dogs to Participate in the Study:

  • Biopsy-confirmed SCC of the oral cavity (mouth) that is not amenable surgical removal or for which the owner has declined surgical removal
  • Dogs in generally good health without significant concurrent illness

Exclusion Criteria:

  • Primary tumor significantly smaller than 3 cm or larger than 6 cm in maximal diameter
  • Presence of cancer metastasis to any organ
  • Presence of serious heart or lung disease that would preclude general anesthesia for radiation therapy
  • Presence of bleeding problems that would preclude tumor biopsy

Financial Support:

  • The total cost to the client for radiation therapy and associated diagnostic test will be discounted to a flat fee of $1,000 (regular cost approximately $6,000)

Trial Starting Date:

  • Currently ongoing
  • NOTE: A 2-week lead-time is needed to produce the nanoparticle treatment for each dog enrolled, so dogs requiring urgent radiation therapy may not be ideal candidates for this trial.

For Questions, please call:

Dr. Michael Childress at (765) 494-1107

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Canine Splenic Hemangiosarcoma

Clinical evaluation of propranolol in combination with doxorubicin for the treatment of splenic hemangiosarcoma in dogs.

Investigators: Dr. Michael Childress

Background:
Hemangiosarcoma of the spleen is a life-threatening cancer in dogs for which few effective treatments exist. Survival times for dogs treated with standard therapy – surgical removal of the spleen followed by doxorubicin chemotherapy – are usually in the range of 4-6 months. Recent research in dogs and in humans with a similar cancer called angiosarcoma suggests that a class of drugs called beta blockers may be effective for treating hemangiosarcoma. The purpose of this study is to determine the optimal dose of the beta blocker drug, propranolol, to use in combination with doxorubicin chemotherapy for dogs that have previously undergone surgical removal of the spleen to treat hemangiosarcoma.

Eligibility:
  • Histopathologic confirmation of splenic hemangiosarcoma, as confirmed by biopsy of a surgically removed spleen.
  • Surgical removal of spleen performed within 2 weeks of initial presentation to Purdue University Veterinary Teaching Hospital
  • No evidence of cancer metastasis identified at the time of surgery or at the time of initial presentation to Purdue University

Exclusion Criteria:

  • Evidence of hemangiosarcoma metastasis at baseline
  • Body weight ≤ 15 kg
  • Significant organ dysfunction preventing safe treatment with doxorubicin
    • Heart disease - including, but not limited to, cardiomyopathy, congestive heart failure, ventricular arrhythmia, AV block
    • Serious kidney or liver dysfunction
    • Serious bone marrow dysfunction
    • Serious blood clotting problems
  • Prior treatment with chemotherapy or radiation therapy for hemangiosarcoma
  • Prior treatment with herbal or holistic products – e.g. I’m-Yunity, yunnan baiyao, CBD oil

Financial Support:
  • Owners of dogs qualifying for the study will be responsible for $150 for the cost of initial staging diagnostic tests (regular cost approximately $1,100)
  • Owners of dogs qualifying for the study will be responsible for $100 towards each doxorubicin chemotherapy treatment involved in the study (maximum of 5 treatments, normal cost $475 each).
  • All other costs associated with trial participation (e.g. x-rays, ultrasonography for restaging; cost of propranolol) are borne by the study and are at no cost to the owner

Trial Starting Date:

  • Enrolling Now!

For Questions, please call:

Dr. Michael Childress at (765) 494-1107

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Canine Urinary Bladder Cancer

Enhancing the Immune System to Fight Bladder Cancer in Dogs

Primary Investigators: Dr. Debbie Knapp, Dr. Deepika Dhawan, and collaborators

DESCRIPTION OF THE WORK:

There is increasing recognition that the immune system is critical in combatting cancer and in making several types of cancer drugs work better. There is growing evidence that the drug, piroxicam, most likely has antitumor effects through augmenting the immune response to the cancer. The purpose of this study is to determine the effects of piroxicam on the immune response to bladder cancer in dogs. By obtaining this information, piroxicam treatment can be improved, and piroxicam can be used to make other cancer drugs (including emerging immunotherapy drugs) work more effectively.

What is involved for the dog? The dog will visit the Purdue University Veterinary Teaching Hospital for tests to assess the dog’s overall health, to determine how extensive the cancer is, and to obtain samples of the tumor collected noninvasively using an instrument called a cystoscope (a tube shaped instrument size of a urinary catheter) while the dog is under anesthesia. These tests typically take two days. After these tests, the dog will go home with a prescription for piroxicam capsules to be given by mouth once per day by the dog owner. The dog will come back to the Purdue University Veterinary Teaching Hospital a month later for repeat evaluation and cystoscopy. This will also likely be a two day visit. After this, the dog will be allowed to continue to receive piroxicam as long as the medication is controlling the cancer, the dog’s quality of life is good, and the dog can come to Purdue at ~6-week intervals for evaluation.

To be eligible for the study, the dog must have transitional cell carcinoma (TCC, also called urothelial carcinoma), normal kidney function, and a tumor mass that can be biopsied through a cystoscope. The dog cannot be receiving any nonsteroidal anti-inflammatory drugs (NSAIDs), and the dog cannot have received NSAIDs for more than 2 weeks in the previous 6 months. After discussing the study with the attending veterinarian, the dog owner will sign a consent form to allow the dog participate if the pet owner wishes for the dog to be part of the study.  

The first 2 months of the study are free to the dog owner, and subsequent costs to the owner are $150.00 (or less) every 6 weeks for the piroxicam and monitoring. Dogs that do not respond to piroxicam can receive other cancer therapies off study at the dog owner’s expense. To learn the most about the piroxicam effects on the TCC, the dog owner is asked to allow a necropsy (autopsy) when the dog dies.

For more information or to schedule an appointment, please contact Ms. Lindsey Fourez, Interim Clinical Trials Coordinator, at 765 494-1130, or email lfourez@purdue.edu.

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Study of the Causes and Outcome of TCC in Dogs

Primary Investigators: Dr. Debbie Knapp, Dr. Deepika Dhawan, and collaborators

Description of the Work:

Work is ongoing on several fronts to gain a better understanding of how TCC forms, what makes it respond to therapy or not, and what makes it progress. Veterinarians at Purdue are working diligently in this field, and have also teamed up with multiple scientists on campus and across the country to do molecular analyses to address these critical questions. In order to accomplish this work, it would be extremely helpful to obtain samples of blood, urine, and tumor tissue from dogs with TCC, and to be allowed to perform necropsies on dogs with TCC if they are to be euthanized due to declining quality of life related to the cancer or other conditions. This applies to dogs who are already patients of the Purdue University Veterinary Teaching Hospital and to other dogs that have not yet been to the Teaching Hospital, but which have confirmed or presumptive TCC.

Samples from dogs of any breed are very helpful. In addition to the work being done in dogs of any breed, dogs from breeds that have a higher risk of TCC (Scottish Terriers, West Highland White Terriers, Shetland Sheepdogs, Beagles) are also needed for a collaborative study with Dr. Elaine Ostrander at the National Institutes of Health. Work in these high risk breeds is defining underlying genetic factors that increase TCC risk, and that could lead to strategies to prevent TCC, or to find it earlier and treat it more effectively. Samples from dogs that already have TCC and samples from older dogs in high risk breeds that do not have cancer are needed.

To learn more about the TCC studies or to set up an appointment, please call: Ms. Lindsey Fourez at (765) 494-1130 or (765) 494-1107. Samples from high risk breed dogs can also be shipped directly to Dr. Ostrander's lab.

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Canine Lymphoma

We are currently recruiting dogs with multicentric lymphoma for multiple ongoing clinical studies.

We realize that lymphomas may progress rapidly and that prompt treatment is imperative for optimal patient care. We therefore make every effort to receive patients with a confirmed or tentative diagnosis of lymphoma as quickly as possible. Usually, appointments are available within 24-48 hours' notice.

If you are a veterinarian interested in referring a canine patient with lymphoma for treatment, or if you would like additional information about these studies, please call the VTH at (765) 494-1107 and ask to speak with Ms. Sarah Lahrman, RVT, or Dr. Michael Childress.

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Multicentric Lymphoma

Biodynamic Imaging (BDI) as a Promising Strategy for Personalized Therapy of Canine Diffuse Large B-cell Lymphoma

Primary Investigator:

Dr. Michael Childress

Background:

Diffuse large B-cell lymphoma (DLBCL), the most common type of lymphoma in dogs, is associated with varying degrees of clinical aggressiveness.  The standard treatment for DLBCL, combination chemotherapy with cyclophosphamide, doxorubicin, vincristine, and prednisone (i.e. “CHOP”) affords cancer remission to 80-90% of affected dogs and significantly extends survival in most cases.  However, some dogs with DLBCL derive little benefit from CHOP, a therapy that is expensive and may produce serious side effects in some dogs.  Methods to accurately predict which dogs are and are not likely to benefit from CHOP are therefore desirable.  We have recently shown that a novel tumor tissue imaging technology called biodynamic imaging (BDI) predicts the responsiveness of canine DLBCL to CHOP with approximately 84% accuracy.  The purpose of this study will be to expand the use of BDI in a larger population of dogs with DLBCL to more fully define its predictive capability.  Tissue biopsy samples will be collected from all dogs in this study prior to administering chemotherapy and at the time that their cancer first relapses after receiving chemotherapy.  These biopsy samples will be analyzed using BDI in order to develop a more complete understanding of the ability of this technology to predict the response of DLBCL in dogs to CHOP chemotherapy.     

Eligibility for Dogs to Participate in the Study:

  • Cytologically-confirmed lymphoma primarily affecting peripheral lymph nodes
  • At least one peripheral lymph node ≥2 cm in longest diameter
  • Expected survival time of ≥ 4 weeks with treatment
  • No prior therapy for the lymphoma, including corticosteroids such as prednisone and dexamethasone 

Exclusion Criteria:

  • Confirmed or suspected T-cell lymphoma or lymphoma other than DLBCL
    • Dogs with hypercalcemia
    • Dogs with cranial mediastinal masses
    • Dogs at high risk for T-cell lymphoma – Boxer, Asian/Arctic breeds (unless confirmed to have DLBCL by histopathology)
    • Lymphoma originating at extranodal sites (e.g. mediastinum, skin, gastrointestinal tract)
    • Dogs at risk for the ABCB1-1D mutation (p-glycoprotein mutation)
      • Collie, Border collie, Shetland sheepdog, Australian shepherd, Old English sheepdog
      • These dogs are at increased risk for adverse reactions to cancer chemotherapy drug treatment, and may not tolerate standard drug doses used in CHOP
      • Dogs weighing <15 kg
      • Dogs displaying significant lymphoma-associated illness (i.e. “substage B”) or with serious comorbid diseases
      • Dogs that have received prior chemotherapy (including prednisone or other corticosteroids) or radiation therapy to treat their lymphoma

Financial Support:

  • The cost of initial tumor biopsy is discounted by $250.
  • The cost of tumor biopsy at the time of cancer relapse is fully covered by the study.
  • CHOP chemotherapy is provided at a discounted rate to dogs enrolled in this study.

Trial Start Date:

Currently ongoing

For Questions, Please Call:

Ms. Sarah Lahrman, RVT, or Dr. Michael Childress at (765) 494-1107

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Biodynamic Testing of Chemotherapy Sensitivity in Dogs Receiving Gemcitabine for Cutaneous T-cell Lymphoma

Primary Investigator:

Dr. Michael Childress

Background:

Epitheliotropic cutaneous T-cell lymphoma (ETCL) in dogs is a skin cancer for which few effective therapies exist.  The chemotherapy drug gemcitabine is commonly used to treat humans with this cancer.  Although gemcitabine has been shown to be well-tolerated in dogs, its use as a treatment for dogs with ETCL has not been described.  In this clinical trial, we will enroll 10 dogs with ETCL to test the efficacy of gemcitabine against this cancer.  In addition, we will test the ability of a novel tissue imaging technology, biodynamic imaging (BDI), to predict the responsiveness of ETCL to gemcitabine.  We have shown in previous studies BDI predicts the response of primary nodal lymphomas in dogs to chemotherapy with approximately 80-90% accuracy.  This will be the first time that BDI is used to predict the response of canine ETCL to a chemotherapy drug.  All dogs enrolled in this study will undergo biopsy of one or more skin tumors at the time of trial entry to provide tissue for BDI.  All dogs will then receive 6 gemcitabine infusions over a period of 8 weeks while participating in this study.

Eligibility for Dogs to Participate in the Study:

  • Histopathologically-confirmed ETCL (tumors diagnosed outside of Purdue must undergo pathology review at the Purdue Animal Disease Diagnostic Laboratory (ADDL) before dogs can be enrolled)
  • Dogs with any stage of disease are eligible.  However, dogs must have at least 2 grossly apparent ETCL lesions, one of which must be suitable for biopsy to provide tissue for BDI.
  • No chemotherapy or radiotherapy in the past 2 weeks.  Dogs must not have received any corticosteroids for at least 7 days prior to study enrollment.
  • Expected survival of at least 2 months with treatment
  • Absence of serious comorbid disease

Exclusion Criteria:

  • Non-epitheliotropic cutaneous T-cell lymphoma or other cutaneous lymphomas
  • Disease lesions too limited for biopsy
  • Organ dysfunction considered likely to affect tolerability of sedation/biopsy or gemcitabine:
    • Hematocrit <25%
    • Neutrophils <2,500/ml
    • Platelets <50,000/ml
    • Creatinine ≥2.1 mg/dl
    • Increased bilirubin
    • Serum ALT >4X normal without concurrent increase in ALP
    • Evidence of hepatic synthetic failure
    • Clinically evident coagulopathy
    • Serious cardiorespiratory disease
    • Prior chemotherapy or radiotherapy within past 14 days
    • Prior prednisone or other glucocorticoids within past 7 days
    • Body weight <15 kg

Financial Support:

  • Pet owners will be responsible for $100 towards the cost of initial office visit and clinical evaluation to determine their dog’s eligibility for participation in the study (normal cost approximately $450).
  • Pet owners will be responsible for $25 for each gemcitabine treatment given to their dog while it is enrolled in the study, up to a maximum of 6 treatments (normal cost approximately $200 per treatment).

Trial Start Date:

Currently Ongoing

For Questions, Please Call:

Ms. Sarah Lahrman, RVT, or Dr. Michael Childress at (765) 494-1107 

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Dogs With Any Biopsy-confirmed Cancer

Piroxicam with Omeprazole or Famotidine (POOF) Clinical Trial for Dogs with Cancer

Primary Investigator:

Dr. Christopher Fulkerson

Background:

Piroxicam is a non-steroidal anti-inflammatory drug (NSAID) commonly prescribed as a treatment for dogs with cancers.  It has been shown to produce measurable tumor regression in dogs with bladder cancer (transitional cell carcinoma), squamous cell carcinoma, mammary cancer, and other cancer types.  However, piroxicam also may cause gastrointestinal side effects, such as vomiting, diarrhea, or loss of appetite, in some dogs.  Drugs to protect the gastrointestinal tract (i.e. gastroprotectant drugs) are often prescribed in an attempt to limit these side effects of piroxicam.  However, it is not clear whether these drugs actually have a protective effect in this setting.  In fact, some evidence suggests that gastroprotectant drugs may unexpectedly increase the risk of piroxicam-related gastrointestinal side effects in cancer-bearing dogs.  This clinical trial will more clearly define the influence of gastroprotectant medications on the side effects of piroxicam.  Dogs in this trial will be randomly assigned to treatment with piroxicam alone, or piroxicam plus one of two gastroprotectant medications – omeprazole (Prilosec) or famotidine (Pepcid AC).  The rate of gastrointestinal side effects in these three groups of dogs will be evaluated over a 3-month treatment period.

Eligibility for Dogs to Participate in the Study:

  • This study is open to all dogs with a histopathologically-confirmed cancer.

Exclusion Criteria:

  • Evidence of kidney dysfunction (abnormal serum BUN, creatinine concentrations)
  • Evidence of liver dysfunction (increased bilirubin, ALT, ALP).
  • Prior history of side effects after receiving other NSAID drugs (e.g. Deramaxx, Previcoxx, Rimadyl, Metacam, aspirin).
  • Concurrent use of gastroprotectant drugs or other drugs for gastrointestinal disease signs
    • Famotidine, ranitidine, cimetidine
    • Omeprazole
    • Maropitant (Cerenia)
    • Ondansetron (Zofran), dolasetron (Anzemet)
    • Sucralfate
    • Misoprostol
    • Signs of gastrointestinal disease (e.g. vomiting, diarrhea, loss of appetite, weight loss, blood in stools) at the time of study entry.
    • Prior chemotherapy, radiation therapy, NSAIDs, or corticosteroid drugs (e.g. prednisone, dexamethasone) for past 2 weeks

Financial Support:

  • Pet owners will receive a financial incentive of $65 per monthly visit while their dog is participating in this trial.  This will cover the cost of piroxicam therapy for each dog.
  • Office visit fees will be waived for dogs participating in this study, and the cost of laboratory diagnostic tests (e.g. blood tests, urinalysis) will be discounted by 15%.

Trial Start Date:

TRIAL CURRENTLY ON HOLD

For Questions, Please Call:

Dr. Christopher Fulkerson or Dr. Marejka Shaevitz at (765) 494-1107

 

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