Oncology Clinical Trials

Canine Urinary Bladder Cancer

Urinary bladder cancer, and specifically invasive transitional cell carcinoma or "TCC" or "InvTCC" in dogs, is an ongoing focus of research in the Purdue Comparative Oncology Program. Information learned from pet dogs with TCC is expected to help the individual dog, other dogs with the same type of cancer, and potentially humans with invasive bladder cancer. Two new treatment studies for dogs with TCC have recently started at Purdue (as of April, 2013).

Scottish Terrier Screening Study

This study will begin September 1, 2014. For information, read this article by Dr. Marcia Dawson, Chairman of the Health Trust Fund (Scottish Terrier Club of America).

Click here for an exciting update on our Scottish Terrier Screening Study. Support TCC Bladder Cancer Research with a gift or pledge to the Scottish Terrier Screening Study.

We are thrilled to announce a most generous donation from the Scottish Terrier Club of Chicago Rescue group. Through the efforts primarily of Sue Severtsen and Caryl Alten, this group has raised over $22,000 which was presented to Dr. Knapp and her staff at the Purdue Comparative Oncology Program. This gift will be matched "dollar for dollar" and will go exclusively to the continuation of the Scottish Terrier Screening Study and to further Scottish Terrier bladder cancer studies.

"Because of this generous donation, we are well on our way to funding the second year of this very important study," said Dr. Debbie Knapp, director of the Oncology Program and canine bladder cancer researcher for over 25 years. "We see that the Chicago Club has set a 'high bar' that other individuals and groups will be encouraged to follow".

EGR-Directed Toxin

Primary Investigators: Dr. Deborah Knapp

By attaching a toxin to an “epidermal growth factor (“EGF”), it is expected to enter cancer cells more readily via the EGF receptor of TCC and EGFR expression than normal cells and to be better able to kill the cancer cells.  It is instilled directly into the bladder.

Eligibility: 

• Confirmed histopathology
• Measurable disease in the bladder than can be followed to assess antitumor effects
• Expected survival of 6 weeks or more
• Normal blood counts
• Pet owner consent

Compensation:  $100 per month.  All treatments must be done at Purdue.

UPCOMING STUDIES

A new targeted therapy to kill cancer cells that have a specific mutation is expected to be available for dogs in a clinical trial later this year.

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. Chris Royce, or Ms. Amalia de Gortari, at (765) 494-1130 or (765) 494-1107. Samples from high risk breed dogs can also be shipped directly to Dr. Ostrander's lab.

Canine Lymphoma

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

A Note on Prednisone: Please note that treatment of canine lymphoma with prednisone prior to initiation of multidrug chemotherapy has been associated with increased chemotherapeutic drug resistance and reduced remission and survival times. Therefore, dogs previously treated with prednisone are unfortunately not eligible for some of the ongoing trials. If you are a veterinarian interested in referring a canine patient with lymphoma to the Purdue University Veterinary Teaching Hospital (PUVTH) for treatment, please do not prescribe prednisone for that patient.

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.

Cutaneous Lymphoma

Phase 2 Study of External Beam Radiation Therapy for Dogs with Localized Epitheliotropic Cutaneous T-cell Lymphoma

Primary Investigators: Dr. Michael Childress, Dr. Nicholas Rancilio

Background:

Epitheliotropic cutaneous T-cell lymphoma (ETCL) is an uncommon form of skin cancer in dogs.  It is most often treated with the oral chemotherapy drug, lomustine.  However, lomustine rarely controls the cancer for longer than a few months.  Radiation therapy is an effective treatment for humans with ETCL, affording long-term cancer control to 70-80% of patients.  Limited reports also suggest radiation therapy would be highly effective to treat dogs with ETCL.  Unfortunately, the degree of benefit radiation would confer to the average dog with this cancer is impossible to estimate based upon the few published reports of its use.  The purpose of this study is therefore to determine the efficacy of a standardized radiation therapy treatment protocol for dogs with localized ETCL.

Eligibility for Dogs to Participate in the Study:

• Histopathologically-confirmed epitheliotropic T-cell lymphoma (histopathologic review of biopsy samples at Purdue Animal Disease Diagnostic Laboratory is necessary)
• Lymphoma confined to one anatomic region treatable within a single radiation field, or two abutting fields.  Dogs with disease spread to regional lymph nodes are eligible.
• Generally good performance status and absence of serious concurrent illness.

Exclusion Criteria:

• Lymphomas other than cutaneous T-cell lymphoma
• Lymphoma spread beyond the regional lymph node to organs such as distant lymph nodes, spleen, liver, or bone marrow
• Serious concurrent illness including, but not limited to, congestive heart failure, cardiac arrhythmias, life-threatening respiratory illness, or advanced stage liver or kidney disease

Financial Support:

• Radiation therapy is provided at a discounted rate of $3,000 (normal cost $4,000-4,500)
• Initial staging tests are provided at a discounted rate of $1,000 (normal cost $1,250)

Trial Start Date: Currently ongoing

For Questions, Please Call: MS. Sarah lahrman, RVT or Dr. Michael Childress at 765-494-1107

Canine Osteosarcoma

Prospective Clinical Trial of Amputation Plus Carboplatin and Piroxicam Chemotherapy for Dogs with Appendicular Skeletal Osteosarcoma

Primary Investigators: Dr. Michael Childress, Dr. Sonia Honkisz

Background:

The standard therapy for canine appendicular skeletal osteosarcoma is amputation of the affected leg followed by chemotherapy. However, this therapy is rarely curative, with most dogs living an average of 10-12 months following amputation. Piroxicam is a non-steroidal anti-inflammatory drug (NSAID) with antitumor effects against several cancers. We are investigating whether adding piroxicam to standard carboplatin chemotherapy will improve survival time in dogs with appendicular skeletal osteosarcoma following amputation.

Eligibility for Dogs to Participate in the Study:

• Histopathologically diagnosed appendicular skeletal osteosarcoma
• Normal kidney function
• Suitable candidate for limb amputation, if amputation has not already been performed

Exclusion Criteria:

• Axial skeletal or extraskeletal osteosarcoma
• Presence of measurable or radiographically detectable metastatic cancer
• Renal azotemia
• Unsuitable candidate for amputation (will be assessed on a patient-to-patient basis)

Financial Support:

• Laboratory tests related to the study will be discounted by 15%
• Fees for office visits will be waived

Trial Start Date: Currently ongoing

For Questions, Please Call: Dr. Michael Childress at 765-494-1107

Canine Soft Tissue Sarcoma

Pilot Study Involving a Novel Nanoparticle Radiosensitizer in Pet Dogs with Soft Tissue Sarcomas

Investigators: Dr. Michael Childress, Dr. Nicholas Rancilio

Background

Soft tissue sarcomas in dogs represent a diverse group of tumors with similar clinical characteristics (locally invasive growth, rare metastasis).  Surgical removal is the treatment of choice for soft tissue sarcoma, but is sometimes not possible due to their invasive growth.  Palliative radiation therapy is useful for temporarily controlling the growth of soft tissue sarcomas, but it cannot provide durable cures of these cancers.  In this study, we will be investigating how well a new calcium tungstate nanoparticle therapy developed by scientists at Purdue works to sensitize soft tissue sarcomas to radiation treatment.  This treatment may hold great promise for improving the effectiveness of radiation therapy to treat soft tissue sarcomas in dogs in the future.

Eligibility for Dogs to Participate in the Study:

• Biopsy-confirmed soft tissue sarcoma of the trunk or limbs that is not removable with surgery or for which the owner has declined surgical removal
• Generally good health and absence of serious concurrent illness

Exclusion Criteria: 

• Primary tumors located in the head/neck or pelvis
• Primary tumor significantly smaller than 4 cm or significantly larger than 6 cm in maximum diameter
• Serious concurrent illness (e.g. heart or lung disease, bleeding tendency) that would prevent general anesthesia or repeated tumor biopsy. 
• Presence of cancer metastasis to any organ

Risks and Benefits of the Procedure:

• Radiation therapy may cause side effects in the skin overlying the tumor similar to a hot spot or rash. These are called acute side effects and are usually mild and self-limiting. If acute side effects occur at all they will resolve. In traditional palliative radiation therapy the frequency of acute side effects is about 1 in 10 cases.
• The addition of the nanoparticle treatment to the radiation therapy protocol may make these side effects occur more frequently or more intensely, but they are still expected to be self-resolving. Acute side effects are managed with pain medications and topical medications to ease discomfort.
• By participating in this study your dog may incur benefit over and above what is expected from palliative radiation therapy. You will also be helping us to investigate new treatments for cancer in dogs and humans.

Financial Support

• All dogs in this study will receive once-daily radiation treatments for 5 consecutive days (M-F).  Each dog will receive an injection of the nanoparticle treatment directly into its tumor immediately prior to the first radiation treatment.  The dogs will also undergo 3 computed tomography (CT or “CAT”) scans, which will help to plan the radiation treatments and will provide a measure of how much the tumors shrink in response to radiation treatment.  Three small tumor tissue biopsy samples will be collected from each dog’s tumor at different time points during the course of treatment. 
• The total cost to clients of dogs enrolled in this study will be $1,000 (normal cost $5,760)

For Questions, Please Call: Dr. Michael Childress at 765-494-1107