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Oncology Clinical Trials

Canine Urinary Bladder Cancer

Zebularine ("Zeb") Treatment of TCC in Dogs

Primary Investigators:

Dr. Debbie Knapp, Dr. Chris Fulkerson

Background: 

What is a clinical trial?Zeb is an oral medicine in a new category of cancer drugs called demethylating agents. Demethylating agents work differently than traditional cancer drugs. Traditional cancer drugs stop DNA replication or block cancer cell division by similar means. Demethylating agents reactivate genes within the cancer cells called tumor suppressor genes. In humans and dogs that do not have cancer, tumor suppressor genes are working to prevent cancer from forming and growing. In dogs and humans that do have cancer, however, the tumor suppressor genes are not working correctly. An important mechanism that keeps these genes from working properly is through the attachment of methyl groups to a specific part of the gene. Zeb and similar drugs remove the methyl groups or prevent methyl groups from attaching, thereby allowing the tumor suppressor genes to return to their normal function, i.e. stopping cancer. Zeb has been very well tolerated with few side effects at the doses being used in dogs. There are two components to this study: (1) to determine how well zeb works by itself, and (2) to determine the beneficial effects of zeb given with a traditional chemotherapy drug called carboplatin.

Eligibility for Dogs to Participate in the Study:
  • Tissue biopsy diagnosis of TCC

  • Tumor mass in bladder or urethra measurable by ultrasound

  • Expected survival of at least 6 weeks

  • Informed written consent from the pet owner

What the Study Involves:

The study involves visits to the Purdue University Veterinary Teaching Hospital (PUVTH) to determine if the dog is eligible for the study and to be sure the study is the best option for the dog. Tests will include x-rays, ultrasound, and blood and urine test. Zeb will be given by mouth by the dog owner, and this will typically be done once per day. For dogs also receiving carboplatin, this drug will be given by an intravenous treatment every 3-4 weeks. The treatment can continue as long as the dog is benefiting from it and there are no bothersome side effects. If the treatment does not control the cancer as expected, or if the drug(s) initially work but fail at a later date, or if the study drugs cause any unacceptable side effects, then the dog would go off study and could receive other treatments for the TCC. Pet owners are asked to consider allowing a necropsy ("autopsy") at Purdue when the dog dies as very important information could be learned that would help other dogs and also potentially help humans.

Financial Support:

Once the dog is found to be eligible for the study and enrolls in the study, the expenses incurred at the PUVTH related to the drug(s), monitoring for antitumor effects, and monitoring for any side effects, are covered by the study as long as the dog is participating in the study. Even if the dog is no longer on the treatment study, expenses related to necropsy are also covered by the study. Expenses incurred that are related to other medical conditions, routine health care, and any expenses incurred outside of the PUVTH are the responsibility of the pet owner.

Appointments and Information:

Appointments for dogs with TCC or suspected TCC are usually handled through Dr. Knapp and the Bladder Cancer Clinic on Mondays, although emergency cases can be seen on other days of the week.

If you have questions or would like more information, please contact: Ms. Patty Bonney, RVT, at (765) 494-1130 or (765) 494-1107, or contact Dr. Christopher Fulkerson at (765) 494-1107. To make an appointment, you may talk to Ms. Bonney or you may call the Small Animal Clinic Reception area at (765) 494-1107.

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Folate-targeted Therapy ( EC0531, Folate-tubulysin) to Treat TCC in Dogs

Primary Investigator:  

Dr. Debbie Knapp

Background: 

Veterinarians in the PCOP have been working with Dr. Phil Low in the Chemistry Department at Purdue University and with Dr. Chris Leamon and colleagues at Endocyte, West Lafayette, IN to evaluate folate-targeted therapy for dogs with TCC. Briefly, Dr. Low's laboratory made an important discovery a few years ago that certain cancers in humans and animals take up much more of the vitamin folate than normal cells, sometimes 100 times more. This provides the opportunity to attach cancer treatment agents to folate in order to selectively "deliver" the cancer drugs to the cancer cells with much less exposure to normal cells. This is expected to allow more effective treatment of the cancer while having less risk of side effects. Folate-targeted therapy is already showing promise in clinical trials in humans with ovarian and lung cancer, but has not yet been studied in humans with bladder cancer. A study has already been completed at Purdue showing that folate attached to the chemotherapy drug vinblastine has good antitumor activity against TCC in dogs, and that the drug can be given safely. The new clinical trial for dogs will include a different folate-drug conjugate, folate attached to a cancer drug called tubulysin. Based on work in cell culture and work in laboratory animals, folate-tubulysin is expected to be even more effective than folate-vinblastine. It is important to note that the folate uptake in the cancer varies from dog to dog, and tests must be done to determine if an individual dog's tumor takes up the folate. One of the tests to detect folate uptake is a folate scan in which a folate imaging agent is given to the dog, and 2 hours later images of the dog made with a special "x-ray" machine called a gamma camera. The other test is performed on tumor tissue from the dog. If the cancer takes up folate, then it is likely the dog could benefit from folate-targeted therapy, and participation in the study could be considered. If the cancer does not take up folate, then it would be better to pursue different therapy for that particular dog.

Eligibility for Dogs to Participate in the Study:
  • Tissue biopsy diagnosis of TCC

  • Folate uptake noted on folate scan, folate receptor detected in tumor tissue

  • Tumor mass in the bladder or urethra measurable by ultrasound

  • Expected survival of at least 6 weeks

  • Informed written consent from the pet owner

What the Study Involves:

The study involves visits to the Purdue University Veterinary Teaching Hospital (PUVTH) to determine if the dog is eligible for the study and to be sure the study is the best option for the dog. Tests will include x-rays, ultrasound, and blood and urine tests. In the initial treatment, the folate-tubulysin will be given 2 times per week. If the dog is from out of town, some of the treatments can be done by a veterinarian in the dog's home town. The treatments can continue as long as they are being beneficial to the dog. If the folate-tubulysin does not control the cancer as expected, or if it initially works but fails at a later date, or if the drug causes unacceptable side effects (especially those that occur after changing the drug dose), then the dog would go off study and could receive other treatments for the TCC. The pet owners are asked to consider allowing a necropsy ("autopsy") at Purdue when the dog dies as very important information could be learned that would help other dogs and also potentially help humans.

Financial Support:

A grant from the Animal Cancer Foundation and support from private donations made for bladder cancer research in the Purdue University College of Veterinary Medicine will pay for most of the expenses related to the clinical study.

Appointments and Information:

An initial group of dogs has been enrolled.  We are now ready to enroll the next group, as of September 15, 2013.  Please contact us for more information.

Appointments for dogs with TCC or suspected TCC are usually handled through Dr. Knapp and the Bladder Cancer Clinic on Mondays, although emergency cases can be seen on other days of the week.

If you have questions or would like more information, please contact: Ms. Patty Bonney, RVT, or Ms. Lindsey Fourez, RVT, at (765) 494-1130 or (765) 494-1107. To make an appointment, you may talk to Ms. Bonney or Ms. Fourez, or you may call the Small Animal Clinic Reception area at (765) 494-1107.

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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. Patty Bonney, 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.

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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 PUVTH at (765) 494-1107 and ask to speak with Ms. Sarah Lahrman, RVT, or Dr. Michael Childress.

CHOP vs. CHO Chemotherapy for Canine Multicentric Lymphoma

Primary Investigator:

Dr. Michael Childress

Background: 

Combination chemotherapy with cyclophosphamide, doxorubicin, vincristine, and prednisone ("CHOP") is considered the standard of care for canine intermediate-to-high grade multicentric lymphoma. Previous therapy with prednisone is known to decrease remission duration and survival time for dogs with CHOP-treated lymphoma, likely by increasing chemotherapy drug resistance within tumor cells. It is unknown whether removal of prednisone from the CHOP protocol affects drug resistance. In this study, dogs will be randomly assigned to CHOP or CHO (CHOP without prednisone) chemotherapy protocols, and remission rate, remission duration, and survival time will be compared between treatment groups.

Eligibility for Dogs to Participate in the Study:
  • Histopathologically-confirmed (i.e. tissue biopsy) lymphoma

  • Primary multicentric (i.e. nodal) anatomic distribution

Exclusion Criteria:
  • Lymphoma of primary extranodal site (e.g. skin, gastrointestinal tract, mediastinum)

  • Previous treatment with chemotherapy (including prednisone)

Financial Support:
  • The cost of chemotherapy (approximately $5000-6000 over 6 months) will be discounted by 10%

  • Additional financial incentives may be applied to cost of biopsy and initial staging tests at Purdue

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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Application of Biodynamic Imaging for Personalized Chemotherapy in Canine Lymphoma

Primary Investigators:

Dr. Michael Childress, Dr. Michelle Custead

Background: 

Chemotherapy is the standard treatment for multicentric lymphomas in dogs.  Most canine lymphomas respond well to chemotherapy, but the duration of response can vary tremendously from dog to dog, and some dogs’ lymphomas do not respond to chemotherapy at all.  We are currently evaluating a new technology, called biodynamic imaging, as a method for predicting the sensitivity of canine multicentric lymphoma to doxorubicin chemotherapy.  Biodynamic imaging measures cellular and intracellular motion within living tissue samples.  In this study will apply biodynamic imaging to freshly harvested tumor biopsies from dogs with multicentric lymphoma.  Biodynamic imaging of tumor biopsy samples will be done both before and after treatment of the samples with doxorubicin.  All enrolled dogs will subsequently be treated with single-agent doxorubicin chemotherapy, a standard treatment for multicentric lymphoma.  We will subsequently evaluated how well biodynamic imaging predicts likelihood of cancer remission and duration of cancer remission in doxorubicin-treated dogs.

Eligibility for Dogs to Participate in the Study:
  • Cytologically or histopathologically diagnosed multicentric lymphoma

  • Body weight >15 kg (30 lbs)

  • No prior chemotherapy or radiation therapy, including prednisone

  • Expected survival time of at least 4 weeks with treatment

Exclusion Criteria:
  • Primary extranodal lymphoma (e.g. cutaneous, mediastinal, gastrointestinal, etc.)

  • Significant heart disease, including, but not limited to, cardiomyopathy, arrhythmias, or congestive heart failure

  • Significant organ dysfunction, including, but not limited to, kidney failure, liver failure, anemia, neutropenia, or thrombocytopenia

  • Body weight  <15 kg (30 lbs)

  • Prior chemotherapy or radiation therapy, including prednisone

Financial Support:
  • Initial biopsy and staging tests (CBC, serum chemistry, thoracic and abdominal radiographs, abdominal ultrasound, bone marrow aspirate) are funded by the study.

  • Doxorubicin chemotherapy is provided to owners of study dogs at a cost of $100 per month (normally $500 per month)

Trial Start Date:

Currently ongoing

For Questions, Please Call:

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

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Clinical Trial to Determine Activity of MLN0415 in Dogs with High-grade Multicentric Lymphomas

Primary Investigator:

Dr. Michael Childress

Background:

This study involves the use of a new oral chemotherapy agent (MLN0415) for the treatment of canine lymphomas. MLN0415 inhibits a protein known as IKK; this protein is known to contribute to cancer progression and drug resistance in human lymphomas, and the same is suspected in canine lymphomas. This is a pilot study to determine whether MLN0415 has activity against untreated or relapsed canine multicentric lymphomas. MLN0415 will be administered orally twice daily and dogs will be rechecked at Purdue at weekly intervals.

Eligibility for Dogs to Participate in the Study:
  • Histopathologically-diagnosed lymphoma

  • Primary multicentric (i.e. nodal) anatomic distribution

  • Normal kidney function

  • Both untreated and relapsed lymphomas are eligible

Exclusion Criteria:
  • Lymphoma of primary extranodal site (e.g. skin, gastrointestinal tract, mediastinum)

  • Concurrent treatment with other chemotherapy (dogs treated concurrently with prednisone may be eligible if their cancer is progressing in the face of prednisone; please call to inquire about eligibility)

  • Renal azotemia

  • Concurrent infection

Financial Support:

Pet owner financial responsibility is capped at $200 per month.

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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Clinical Trial to Determine Activity of Carboplatin as a Rescue Chemotherapy Agent for Dogs with High-grade Multicentric Lymphomas

Primary Investigator:

Dr. Michael Childress

Background:

Rescue chemotherapy is administered to dogs with lymphomas whose cancer has progressed in the face of first-line chemotherapy treatment. Rescue chemotherapy protocols are often expensive, and drugs used in these protocols have recently been subject to nationwide shortages. Carboplatin is commonly administered to dogs with a variety of cancers, and is well tolerated, relatively inexpensive, and readily available. The activity of carboplatin against canine lymphoma, however, has not been fully evaluated. This study is designed to determine the activity of single agent carboplatin in dogs with relapsed multicentric lymphoma. Dogs will be treated at Purdue with intravenous carboplatin once every 3 weeks.

Eligibility for Dogs to Participate in the Study:
  • Histopathologically-diagnosed lymphoma which has relapsed following first-line chemotherapy

  • Primary multicentric (i.e. nodal) anatomic distribution

  • Normal kidney function

Exclusion Criteria:
  • Lymphoma of primary extranodal site (e.g. skin, gastrointestinal tract, mediastinum)

  • Concurrent treatment with other chemotherapy (dogs treated concurrently with prednisone may be eligible if their cancer is progressing in the face of prednisone; please call to inquire about eligibility)

  • Renal azotemia

Financial Support:

Pet owner financial responsibility is capped at $100 per month.

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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COTC007b: Preclinical Comparison of Three Indenoisoquinolines Candidates in Tumor-bearing Dogs

Primary Investigator:

Dr. Michael Childress

Background:

This is a multi-institutional trial administered through a division of the National Cancer Institute. Purdue is one of a group of veterinary schools (collectively known as the Comparative Oncology Trials Consortium, or COTC) enrolling dogs in this clinical trial. The trial is designed to determine the pharmacokinetics, maximally tolerated dose, and anti-tumor activity of three new chemotherapy agents in dogs with lymphoma. Data from this trial will be used to design similar, follow-up trials in human cancer patients. Dogs enrolled in this study will be boarded at the Purdue for 7 days, and will receive chemotherapy treatment on 5 consecutive days within this span. Dogs whose cancers respond to chemotherapy will be eligible for additional treatments given for 5 consecutive days, once every 3 weeks.

Eligibility for Dogs to Participate in the Study:
  • Histopathologically or cytologically confirmed multicentric lymphoma

  • Absence of clinical signs of illness (substage a)

  • Both newly diagnosed and relapsed lymphomas are eligible

Exclusion Criteria:
  • Lymphoma of primary extranodal site (e.g. skin, gastrointestinal tract, mediastinum)

  • Dogs <15 kg

  • No corticosteroids or L-asparaginase for 7 days prior to study initiation

  • No chemotherapy or radiation therapy for 2 weeks prior to study initiation

  • Significant comorbid illness (i.e. substage b; please call to discuss eligibility of patients with clinical signs of illness)

Financial Support:
  • Significant funding is available. All costs related to therapy are covered by the study.

  • Owners enrolling their dogs in this study will also receive an incentive of $1,000 that may be used to pursue additional chemotherapy at Purdue once their dog is no longer enrolled in the 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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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

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